Adjunctive SPD489 to Antipsychotic Medication in Clinically Stable Adults With Persistent Predominant 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 whether SPD489 40 mg, 100 mg, and 160 mg are effective and safe in the treatment of Negative Symptoms of Schizophrenia (NSS).

Official Title
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A Phase 3 Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, 12-week, Forced-dose Titration Study to Evaluate the Efficacy, Safety, and Tolerability of SPD489 40mg, 100mg, or 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

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: SPD489 40mg
* Drug: SPD489 100mg
* Drug: SPD489 160mg
* Drug: Placebo


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 day

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SPD489 40mg<br> | Drug: SPD489 40mg<br>* Oral administration of 40 mg once-daily for up to 12 weeks<br>* Other names: lisdexamfetamine dimesylate, LDX, Vyvanse;|
| Experimental: SPD489 100mg<br> | Drug: SPD489 100mg<br>* Oral administration of 100 mg once-daily for up to 12 weeks<br>* Other names: lisdexamfetamine dimesylate, LDX, Vyvanse;|
| Experimental: SPD489 160mg<br> | Drug: SPD489 160mg<br>* Oral administration of 160 mg once-daily for up to 12 weeks<br>* Other names: lisdexamfetamine dimesylate, LDX, Vyvanse;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Oral administration once-daily for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Negative Symptom Assessment - 16-item (NSA-16) Total Score at 12 Weeks |  | Baseline and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in the Personal and Social Performance Scale (PSP) Score at 12 Weeks |  | Baseline and 12 weeks | 
| Change From Baseline in Simpson Angus Scale (SAS) Total Score at 12 Weeks |  | Baseline and 12 weeks | 
| Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at 12 Weeks |  | Baseline and 12 weeks | 
| Change From Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at 12 Weeks |  | Baseline and 12 weeks | 
| Change From Baseline in the Abnormal Involuntary Movement Scale (AIMS) at 12 Weeks |  | Baseline and 12 weeks | 
| Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Scores at 12 Weeks |  | Baseline and 12 weeks | 
| Change From Baseline in Cognitive Test Battery (CogState Battery) Score at 12 Weeks |  | Baseline and 12 weeks | 
| Change From Baseline in Social Functioning Scale (SFS) at 12 Weeks |  | Baseline and 12 weeks | 
| Change From Baseline in Clinical Evaluation of Harmful Behavior (CEHB) Scale at 12 Weeks |  | Baseline and 12 weeks | 
| Clinical Global Impression-Schizophrenia Severity of Illness (CGI-SCH-S) Scale |  | Baseline and week 12 | 
| Clinical Global Impression-Schizophrenia Degree of Change (CGI-SCH-C) Scale |  | Up to 12 weeks | 
| Columbia-Suicide Severity Rating Scale (C-SSRS) |  | Up to 12 weeks | 
| Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) at 12 Weeks |  | Baseline and 12 weeks | 
| Ambulatory Blood Pressure Monitoring (ABPM) |  | Baseline and Weeks 4 and 10 |