| Study name |
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 |
| Methods |
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 |
| Participants |
Clinical diagnosis of major depressive episode ≤ 24 months in duration HAM‐D17 score ≥ 20 Documented to not have a significant (25% or greater) change in QIDS‐SR16 score between Screening and Baseline visits Patients have been deemed to have an inadequate response (less than 50% symptom reduction) to at least 1 but no more than 3 adequate antidepressant trials during the current depressive episode Patients must be receiving ongoing treatment with an adequate dose of antidepressants Body Mass Index (BMI) of 18‐35 kg/m² |
| Interventions |
AVP‐786 versus placebo |
| Outcomes |
Primary outcome measures: Montgomery‐Ǻsberg Depression Rating Scale (MADRS) total score |
| Starting date |
July 2014 |
| Contact information |
mailto:ldoan%40avanir.com?subject=NCT02153502, 14‐AVP‐786‐201, 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 |
| Notes |
NCT02153502 |
