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



Status:Completed
Conditions:Schizophrenia
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 60
Updated:8/3/2018
Start Date:September 2015
End Date:July 21, 2017

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A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety and Tolerability of AVP-786 (Deuterated [d6]-Dextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) as an Adjunctive Treatment for Patients With Residual Schizophrenia.

The objectives of this 12-week study are to evaluate the efficacy, safety, and tolerability
of AVP-786 as an adjunctive treatment compared with placebo in patients with residual
schizophrenia.


Inclusion Criteria:

- Patients who meet DSM-IV-TR diagnostic criteria for schizophrenia using the M.I.N.I.
version 6.0.

- Patients must meet PANSS criteria

- Patients currently receiving atypical antipsychotics are eligible provided they are on
a stable dose

Exclusion Criteria:

- Patients with current major depressive disorder (MDD)

- Patients with extrapyramidal syndrome secondary to their ongoing antipsychotic
medication

- Patients currently using anticholinergic medications

- Recent in-patient hospitalization
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17
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1919
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Atlanta, GA
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Augusta, GA
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Boston, MA
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Cerritos, CA
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Chicago, IL
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Garden Grove, CA
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Jamaica, NY
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National City, California 91950
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National City, CA
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New York, NY
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350
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Oakland, CA
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Rochester, NY
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105
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San Diego, CA
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Washington,
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2540
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Worcester, MA
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