Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Negative Symptoms of Schizophrenia

Study Overview
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Brief Summary
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This study will be conducted to evaluate the efficacy, safety, and tolerability of AVP-786, as compared with placebo, for the treatment of negative symptoms of schizophrenia.

Official Title
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A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-arm Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Negative Symptoms of Schizophrenia

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: Placebo
* Drug: AVP-786


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants who meet the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-V) diagnostic criteria for schizophrenia confirmed by the Mini International Neuropsychiatric Interview (M.I.N.I) Version 7.0.2 Participants must have well-controlled positive symptoms and prominent negative symptoms as defined by Positive and Negative Syndrome Scale (PANSS) criteria. Participants currently receiving a second-generation atypical antipsychotic drug (SGA) are eligible if they are stable and adherent to their dosing schedule. Participants must have a reliable informant (e.g., case manager, social worker, family member). The informant should be able to spend an adequate amount of time with the participant to be able to address behaviors, activities, and symptoms. Exclusion Criteria: Participants with current major depressive disorder (MDD) Participants with pseudo-parkinsonism secondary to their ongoing antipsychotic medication Participants currently using anticholinergic medications Participants recently hospitalized as in-patients

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo capsules will be administered orally twice a day over a 15-week period. | Drug: Placebo<br>* oral capsules<br>|
| Experimental: AVP-786<br>AVP-786 capsules will be administered orally twice a day over a 15-week period. | Drug: AVP-786<br>* oral capsules<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline to Week 15 in the Positive and Negative Syndrome Scale (PANSS) Marder Negative Factors Score |  | Baseline; Week 15 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline to Week 15 in the Negative Symptom Assessment-16 (NSA-16) Global Negative Symptom Score |  | Baseline; Week 15 | 
| Change from Baseline to Week 15 in the Patient Global Impression of Severity (PGI-S) Score |  | Baseline; Week 15 | 
| Change from Baseline to Week 15 in the Patient Global Impression of Change (PGI-C) Score |  | Baseline; Week 15 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Negative Symptoms, Schizophrenia, AVP-786