Assess the Safety and Pharmacokinetics of Ascending, Multiple Oral Doses of SPD489 in Adults With Schizophrenia

A Phase 1, Randomized, Double-blind, Placebo Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ascending, Multiple Oral Doses of SPD489 (Lisdexamfetamine Dimesylate) in Clinically Stable Adults With Schizophrenia

This is a multiple ascending dose study; the purpose of this study is to examine the safety, tolerability and pharmacokinetics (levels of drug in the blood) of SPD489 in Schizophrenic Patients who are currently maintained on a stable dose of an antipsychotic medication.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: SPD489 (Lisdexamfetamine dimesylate); Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Glendale, California, United States, 91206
      • California Clinical Trials
    • Long Beach, California, United States, 90806
      • Collaborative Neuroscience Network, Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Subjects must be diagnosed with schizophrenia, on a stable dose of an antipsychotic and not have any cardiac risk factors

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo Capsule(s) for oral use taken once daily for 30 days
Experimental: SPD489 (Lisdexamfetamine dimesylate)	Drug: SPD489 (Lisdexamfetamine dimesylate); SPD489 administered orally in ascending doses (50mg, 70mg, 100mg, 150mg, 200mg, 250mg). Each of these doses will be administered once daily for 5 days. Total number of days dosed is 30 days.; Other Names: Vyvanse, LDX

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Systolic Blood Pressure at Day 5: 50 mg	Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.	Baseline and day 5
Change From Baseline in Systolic Blood Pressure at Day 5: 70 mg	Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.	Baseline and day 5
Change From Baseline in Systolic Blood Pressure at Day 5: 100 mg	Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.	Baseline and day 5
Change From Baseline in Systolic Blood Pressure at Day 5: 150 mg	Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.	Baseline and day 5
Change From Baseline in Systolic Blood Pressure at Day 5: 200 mg	Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.	Baseline and day 5
Change From Baseline in Systolic Blood Pressure at Day 5: 250 mg	Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.	Baseline and day 5
Change From Baseline in Diastolic Blood Pressure at Day 5: 50 mg	Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.	Baseline and day 5
Change From Baseline in Diastolic Blood Pressure at Day 5: 70 mg	Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.	Baseline and day 5
Change From Baseline in Diastolic Blood Pressure at Day 5: 100 mg	Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.	Baseline and day 5
Change From Baseline in Diastolic Blood Pressure at Day 5: 150 mg	Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.	Baseline and day 5
Change From Baseline in Diastolic Blood Pressure at Day 5: 200 mg	Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.	Baseline and day 5
Change From Baseline in Diastolic Blood Pressure at Day 5: 250 mg	Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.	Baseline and day 5
Change From Baseline in Pulse Rate at Day 5: 50 mg	Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.	Baseline and day 5
Change From Baseline in Pulse Rate at Day 5: 70 mg	Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.	Baseline and day 5
Change From Baseline in Pulse Rate at Day 5: 100 mg	Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.	Baseline and day 5
Change From Baseline in Pulse Rate at Day 5: 150 mg	Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.	Baseline and day 5
Change From Baseline in Pulse Rate at Day 5: 200 mg	Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.	Baseline and day 5
Change From Baseline in Pulse Rate at Day 5: 250 mg	Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.	Baseline and day 5

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 50 mg	AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.	Day 5 (12-hour sampling period post-dose)
Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 70 mg	AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.	Day 5 (12-hour sampling period post-dose)
Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 100 mg	AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.	Day 5 (12-hour sampling period post-dose)
Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 150 mg	AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.	Day 5 (12-hour sampling period post-dose)
Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 200 mg	AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.	Day 5 (12-hour sampling period post-dose)
Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 250 mg	AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.	Day 5 (12-hour sampling period post-dose)
Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 50 mg	Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.	Day 5 (12-hour sampling period post-dose)
Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 70 mg	Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.	Day 5 (12-hour sampling period post-dose)
Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 100 mg	Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.	Day 5 (12-hour sampling period post-dose)
Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 150 mg	Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.	Day 5 (12-hour sampling period post-dose)
Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 200 mg	Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.	Day 5 (12-hour sampling period post-dose)
Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 250 mg	Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.	Day 5 (12-hour sampling period post-dose)
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 50 mg	The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment.	Baseline and Day 5
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 70 mg	The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment.	Baseline and Day 5
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 100 mg	The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment.	Baseline and Day 5
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 150 mg	The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment.	Baseline and Day 5
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 200 mg	The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment.	Baseline and Day 5
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 250 mg	The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment.	Baseline and Day 5
Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 50 mg	The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.	Baseline and Day 5
Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 70 mg	The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.	Baseline and Day 5
Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 100 mg	The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.	Baseline and Day 5
Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 150 mg	The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.	Baseline and Day 5
Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 200 mg	The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.	Baseline and Day 5
Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 250 mg	The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.	Baseline and Day 5
Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 50 mg	CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression.	Baseline and Day 5
Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 70 mg	CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression.	Baseline and Day 5
Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 100 mg	CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression.	Baseline and Day 5
Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 150 mg	CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression.	Baseline and Day 5
Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 200 mg	CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression.	Baseline and Day 5
Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 250 mg	CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression.	Baseline and Day 5
Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 50 mg	SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment.	Baseline and Day 5
Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 70 mg	SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment.	Baseline and Day 5
Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 100 mg	SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment.	Baseline and Day 5
Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 150 mg	SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment.	Baseline and Day 5
Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 200 mg	SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment.	Baseline and Day 5
Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 250 mg	SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment.	Baseline and Day 5
Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 50 mg	BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness.	Baseline and Day 5
Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 70 mg	BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness.	Baseline and Day 5
Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 100 mg	BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness.	Baseline and Day 5
Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 150 mg	BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness.	Baseline and Day 5
Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 200 mg	BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness.	Baseline and Day 5
Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 250 mg	BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness.	Baseline and Day 5
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 50 mg	This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).	Baseline and Day 5
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 70 mg	This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).	Baseline and Day 5
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 100 mg	This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).	Baseline and Day 5
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 150 mg	This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).	Baseline and Day 5
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 200 mg	This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).	Baseline and Day 5
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 250 mg	This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).	Baseline and Day 5
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 50 mg	This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).	Baseline and Day 5
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 70 mg	This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).	Baseline and Day 5
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 100 mg	This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).	Baseline and Day 5
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 150 mg	This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).	Baseline and Day 5
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 200 mg	This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).	Baseline and Day 5
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 250 mg	This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).	Baseline and Day 5
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 50 mg	This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).	Baseline and Day 5
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 70 mg	This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).	Baseline and Day 5
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 100 mg	This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).	Baseline and Day 5
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 150 mg	This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).	Baseline and Day 5
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 200 mg	This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).	Baseline and Day 5
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 250 mg	This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).	Baseline and Day 5
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 50 mg	This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).	Baseline and Day 5
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 70 mg	This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).	Baseline and Day 5
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 100 mg	This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).	Baseline and Day 5
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 150 mg	This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).	Baseline and Day 5
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 200 mg	This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).	Baseline and Day 5
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 250 mg	This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).	Baseline and Day 5

Collaborators and Investigators

• Sponsor: Shire

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2011
• Primary Completion (Actual): January 20, 2012
• Study Completion (Actual): January 20, 2012

Study Registration Dates

• First Submitted: October 19, 2011
• First Submitted That Met QC Criteria: October 19, 2011
• First Posted (Estimate): October 21, 2011

Study Record Updates

• Last Update Posted (Actual): June 3, 2021
• Last Update Submitted That Met QC Criteria: May 13, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Schizophrenia
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Agents; Dopamine Uptake Inhibitors; Central Nervous System Stimulants; Lisdexamfetamine Dimesylate
• Other Study ID Numbers: SPD489-119

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No