drugset / Trial / NCT02153502

Efficacy, Safety, and Tolerability Study of AVP-786 as an Adjunctive Therapy in Patients With Major Depressive Disorder With an Inadequate Response to Antidepressant Treatment

NCT02153502

RandomizedParallel-groupQuadruple-blindTreatment

Summary

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.

Timeline

Start
2014-07-01
Primary completion
2016-02-01
Completion
2016-02-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Deudextromethorphan Unknown Oral
Subject Quinidine Small molecule Oral