SPD489 Low Dose and High Dose Ranges When Added to Stable Doses of Antipsychotic Medications in Clinically Stable Adults With Negative Symptoms of Schizophrenia

A Phase 3 Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, 26-week, Dose-optimization Study to Evaluate the Efficacy, Safety, and Tolerability of SPD489 Low Dose Range (40mg, 80mg, 100mg) and High Dose Range (120mg, 140mg, 160mg) 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 whether SPD489 low dose range (40, 80, or 100mg) and high dose range (120, 140, or 160mg) are effective in the treatment of Negative Symptoms.

Study Overview

• Status: Terminated
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: SPD489 low dose range (40mg, 80mg, and 100mg); Drug: SPD489 high dose range (120mg, 140mg and 160mg); Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami Springs, Florida, United States, 33166
      • Galiz Research
  • Missouri
    • O'Fallon, Missouri, United States, 63368
      • Psychiatric Care and Research Center
    • Saint Charles, Missouri, United States, 63304
      • St. Charles Psychiatric Associates
  • 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: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; One capsule a day for 26 weeks
Experimental: SPD489 Low Dose Range	Drug: SPD489 low dose range (40mg, 80mg, and 100mg); Capsule, dose titration,; 40 mg capsule once-daily for 1 week; then; 80 mg capsule once-daily for 4 weeks; then,; 100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks;; if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks; Other Names: lisdexamfetamine dimesylate, LDX, Vyvanse
Experimental: SPD489 High Dose Range	Drug: SPD489 high dose range (120mg, 140mg and 160mg); Capsule, dose titration,; 40 mg capsule once-daily for 1 week; then; 80 mg capsule once daily for 1 week; then; 120 mg capsule once-daily for 1 week, then,; 140 mg capsule once-daily for 2 weeks, then; 160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks;; if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks; Other Names: lisdexamfetamine dimesylate, LDX, Vyvanse

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change From Baseline in Negative Symptom Assessment (NSA-16) Total Score at 26 Weeks	Baseline and 26 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Change From Baseline in the Personal and Social Performance (PSP) Scale Score at 26 Weeks	Baseline and 26 weeks
Change From Baseline in Simpson Angus Scale (SAS) Total Score at 26 Weeks	Baseline and 26 weeks
Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at 26 Weeks	Baseline and 26 weeks
Change From Baseline in the Abnormal Involuntary Movement Scale (AIMS) at 26 Weeks	Baseline and 26 weeks
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Scores at 26 Weeks	Baseline and 26 weeks
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at 26 Weeks	Baseline and 26 weeks
Change From Baseline in Social Functioning Scale (SFS) at 26 Weeks	Baseline and 26 weeks
Clinical Global Impression-Schizophrenia Severity of Illness (CGI-SCH-S) Scale	Baseline and week 26
Clinical Global Impression-Schizophrenia Degree of Change (CGI-SCH-C) Scale	Up to 26 weeks
Change From Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at 26 Weeks	Baseline and 26 weeks
Change From Baseline in Clinical Evaluation of Harmful Behavior (CEHB) Scale at 26 Weeks	Baseline and 26 weeks
Columbia-Suicide Severity Rating Scale (C-SSRS)	Up to 26 weeks
Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) at 26 Weeks	Baseline and 26 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 3, 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

• 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: SPD489-335; 2012-003919-57 (EudraCT Number)