Depressive Disorder, Treatment-Resistant Clinical Trial
Official title:
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 (Deuterium Modified Dextromethorphan Hydrobromide/Quinidine Sulfate) as an Adjunctive Therapy in Patients With Major Depressive Disorder With an Inadequate Response to Antidepressant Treatment
The objectives of this 10-week study are to evaluate the efficacy, safety, and tolerability of AVP 786 as an adjunctive therapy compared with placebo in patients with major depressive disorder (MDD) who have shown an inadequate response to standard antidepressant treatment. A secondary objective of this study is to assess the pharmacokinetics (PK) of AVP-786 and potential correlations with pharmacodynamic effects.
It is estimated that up to approximately 200 patients will participate in the study at
approximately 30 enrolling centers in the US.
Eligible patients for this study must have MDD as defined by the Diagnostic and Statistical
Manual of Mental Disorders (DSM-IV-TR) criteria, and have shown an inadequate response to
standard antidepressant treatment.
This is a multicenter, randomized, double-blind, placebo-controlled, study of 10 weeks
duration.
Following screening procedures for assessment of inclusion and exclusion criteria, eligible
patients will be randomized into the study. Study medication will be administered orally
twice a day (BID) (1 capsule in the morning and 1 capsule in the evening, approximately 12
hours apart) throughout the treatment period.
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