Long-term Safety of SPD489 When Added to Stable Doses of Antipsychotic Medications in Clinically Stable Adults With Negative Symptoms of Schizophrenia

A Phase 3, Long-term, Open-label, Multicenter, 52-week, Flexible-dose Safety Study of SPD489 as Adjunctive Treatment to Established Maintenance Doses of Antipsychotic Medications on Negative Symptoms in Clinically Stable Adults Who Have Persistent Predominant Negative Symptoms of Schizophrenia

The primary purpose of this study is to determine if the long-term use of SPD489 (40, 80, 100, 120, 140, and 160mg) administered as a daily morning is safe and tolerable.

Study Overview

• Status: Terminated
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: SPD489

Detailed Description

Not required

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • SP Research PLLC/Oklahoma Clinical Research Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19139
      • CRI Lifetree

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

Inclusion Criteria:

• 18 to 65 years of age
• Has a reliable informant (eg, family member, social worker, caseworker, or nurse that spends >4 hours/week with the subject)
• Fixed home/place of residence and can be reached by telephone
• On a stable dose of antipsychotic medications
• Able to swallow capsules

Exclusion Criteria:

• -Taking lithium, carbamazepine, lamotrigine, gabapentin, cholinesterase inhibitors, modafinil, or other stimulants such as methylphenidate and other amphetamine products
• Treated with clozapine in past 30 days
• Lifetime history of stimulant, cocaine, or amphetamine abuse or dependence
• History of seizures (other than infantile febrile seizures), any tic disorder, or current diagnosis and/or a known family history of Tourette's Disorder, serious neurological disease, history of significant head trauma, dementia, cerebrovascular disease, Parkinson's disease, or intracranial lesions
• Uncontrolled hypertension
• History of thyroid disorder that has not been stabilized on thyroid medication
• Glaucoma
• Pregnant or nursing
• Subject has received an investigational product or participated in a clinical study within 30 days

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SPD489	Drug: SPD489; Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks; Other Names: lisdexamfetamine dimesylate, LDX, Vyvanse

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Scores at 52 Weeks	Basline and 52 weeks
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at 52 Weeks	Baseline and 52 weeks
Columbia-Suicide Severity Rating Scale (C-SSRS)	Up to 52 weeks
Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) at 52 Weeks	Baseline and 52 weeks
Change From Baseline in Simpson Angus Scale (SAS) Total Score at 52 Weeks	Baseline and 52 weeks
Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at 52 Weeks	Baseline and 52 weeks
Change From Baseline in the Abnormal Involuntary Movement Scale (AIMS) at 52 Weeks	Baseline and 52 weeks
Change From Baseline in Clinical Evaluation of Harmful Behavior (CEHB) Scale at 52 Weeks	Baseline and 52 weeks
Change From Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at 52 Weeks	Baseline and 52 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Change From Baseline in Negative Symptom Assessment (NSA-16) Total Score at 52 Weeks	Baseline and 52 weeks
Change From Baseline in the Personal and Social Performance (PSP) Scale Score at 52 Weeks	Baseline and 52 weeks
Clinical Global Impression-Schizophrenia Severity of Illness (CGI-SCH-S) Scale	Baseline and week 52
Clinical Global Impression-Schizophrenia Degree of Change (CGI-SCH-C) Scale	Up to 52 weeks
Change From Baseline in Social Functioning Scale (SFS) at 52 Weeks	Baseline and 52 weeks

Collaborators and Investigators

• Sponsor: Shire

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2013
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: January 2, 2013
• First Submitted That Met QC Criteria: January 2, 2013
• First Posted (Estimate): January 4, 2013

Study Record Updates

• Last Update Posted (Actual): June 22, 2021
• Last Update Submitted That Met QC Criteria: May 29, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Not Required
• 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: SPD489-336; 2012-003920-18 (EudraCT Number)