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

Study Overview
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Brief Summary
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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.

Detailed Description
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Not required

Official Title
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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

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: SPD489


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Not Required