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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 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 206

Last updated 2017-05-15

No results posted yet for this study

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.

Conditions

  • Depressive Disorder, Treatment-Resistant

Interventions

DRUG

AVP-786 (d6-dextromethorphan hydrobromide and quinidine sulfate combination)

AVP-786 capsules administered twice a day over a 10-week period

DRUG

Placebo

Placebo capsules administered twice a day over a 10-week period

Sponsors & Collaborators

  • Avanir Pharmaceuticals

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2016-02-29
Completion
2016-02-29

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02153502 on ClinicalTrials.gov