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

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Sequential Parallel Comparison Design (SPCD) 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