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

NCT ID: NCT02153502

Last Updated: 2017-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 206 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2016-02-29

Brief 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.

Detailed Description

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.

Conditions

Depressive Disorder, Treatment-Resistant

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

AVP-786

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

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

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• History of myasthenia gravis.
• Have cardiovascular concerns such as:

• History of complete heart block, QT interval corrected for heart rate (QTc) prolongation, or torsades de pointes.
• QTc using the Fridericia's formula (QTcF) at screening > 450 msec for males and > 470 msec for females based on central review at the screening visit, unless due to ventricular pacing.
• Any family history of congenital QT interval prolongation syndrome.
• Known hypersensitivity/intolerance to DM, Q, opiate drugs (codeine, etc.), or any other ingredient of the study medication.
• Pose a current suicide risk, as evidenced by any of the following:

• It is the judgment of the investigator that the subject may be at risk for suicide.
• The subject is rated a "yes" to question 4 or question 5 on the Baseline C-SSRS, if the most recent episode occurred within the past 12 months.
• The subject has attempted suicide within the past 6 months
• Presence of any other current DSM-IV-TR Axis I disorders with the exception of: generalized anxiety disorder (GAD: 300.02), social anxiety disorder (300.23), dysthymic disorder (300.4), or specific phobia (300.29). Patients with co-morbid GAD, social anxiety disorder, or specific phobia are ineligible if the co-morbid condition is clinically unstable, or has been the primary focus of treatment within the 6 month period prior to screening
• Axis I diagnosis of:

• Delirium, dementia, amnestic, or other cognitive disorder;
• Schizophrenia or other psychotic disorder, based on the M.I.N.I.;
• Bipolar I or II disorder, based on the M.I.N.I.
• Clinically significant Axis II (DSM-IV-TR) diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal or histrionic personality disorder.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Avanir Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Birmingham, Alabama, United States

Birmingham, Alabama, United States

Bellflower, California, United States

Costa Mesa, California, United States

Garden Grove, California, United States

Lomita, California, United States

Oceanside, California, United States

Riverside, California, United States

Santa Ana, California, United States

Sherman Oaks, California, United States

Denver, Colorado, United States

Bradenton, Florida, United States

Jacksonville, Florida, United States

Miami, Florida, United States

Orange City, Florida, United States

Orlando, Florida, United States

Decatur, Georgia, United States

Hoffman Estates, Illinois, United States

Valparaiso, Indiana, United States

Baltimore, Maryland, United States

Glen Burnie, Maryland, United States

Boston, Massachusetts, United States

Brooklyn, New York, United States

New York, New York, United States

Staten Island, New York, United States

Garfield Heights, Ohio, United States

Oklahoma City, Oklahoma, United States

Oklahoma City, Oklahoma, United States

Tulsa, Oklahoma, United States

Philadelphia, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Murray, Utah, United States

Countries

United States

Other Identifiers

14-AVP-786-201

Identifier Type: -

Identifier Source: org_study_id