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Experimental depression drug aims to help when standard meds fail

NCT ID NCT02153502

Disease control Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 13, 2026 · Last updated Jul 14, 2026 · Updated 1 time

Summary

This study tests whether a new drug called AVP-786 can help people with major depressive disorder who have not gotten enough relief from standard antidepressants. Participants take AVP-786 or a placebo alongside their current antidepressant for 10 weeks. The main goal is to see if the drug reduces depression symptoms more than placebo.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AVP-786 (deuterium-modified dextromethorphan hydrobromide and quinidine sulfate combination)
What this could lead to
If successful, this could offer a new option for people with depression that hasn't improved with standard treatments, potentially improving mood and daily function.
What could go wrong
This is an early-phase trial with a small number of participants, so results may not apply to everyone. The drug may cause side effects or prove no better than placebo.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

206 people

The number who actually took part.

Started

Jul 2014

Finished

Feb 2016

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

depressive disorder Depressive Disorder, Treatment-Resistant major depressive disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Depressive disorder, treatment-resistant

Contacts and locations

Locations

  • Study site

    Birmingham, Alabama, 35213, United States

  • Study site

    Birmingham, Alabama, 35294, United States

  • Study site

    Bellflower, California, 90706, United States

  • Study site

    Costa Mesa, California, 92626, United States

  • Study site

    Garden Grove, California, 92845, United States

  • Study site

    Lomita, California, 90717, United States

  • Study site

    Oceanside, California, 92056, United States

  • Study site

    Riverside, California, 92506, United States

  • Study site

    Santa Ana, California, 92706, United States

  • Study site

    Sherman Oaks, California, 91403, United States

  • Study site

    Denver, Colorado, 80239, United States

  • Study site

    Bradenton, Florida, 34201, United States

  • Study site

    Jacksonville, Florida, 32256, United States

  • Study site

    Miami, Florida, 33155, United States

  • Study site

    Orange City, Florida, 32763, United States

  • Study site

    Orlando, Florida, 32801, United States

  • Study site

    Decatur, Georgia, 30030, United States

  • Study site

    Hoffman Estates, Illinois, 60169, United States

  • Study site

    Valparaiso, Indiana, 46383, United States

  • Study site

    Baltimore, Maryland, 21285, United States

  • Study site

    Glen Burnie, Maryland, 21061, United States

  • Study site

    Boston, Massachusetts, 02131, United States

  • Study site

    Brooklyn, New York, 11241, United States

  • Study site

    New York, New York, 10003, United States

  • Study site

    Staten Island, New York, 10312, United States

  • Study site

    Garfield Heights, Ohio, 44125, United States

  • Study site

    Oklahoma City, Oklahoma, 73103, United States

  • Study site

    Oklahoma City, Oklahoma, 73112, United States

  • Study site

    Tulsa, Oklahoma, 74101, United States

  • Study site

    Philadelphia, Pennsylvania, 19104, United States

  • Study site

    Philadelphia, Pennsylvania, 19139, United States

  • Study site

    Murray, Utah, 84123, United States

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