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Could a new combo drug help with Schizophrenia's 'Negative' symptoms?

NCT ID NCT02477670

Symptom relief 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 2 trial tested whether AVP-786, a combination of two drugs, can reduce negative symptoms (like lack of emotion or motivation) in people with schizophrenia. 145 adults on stable antipsychotics received either AVP-786 or a placebo for 12 weeks. The study measured changes in symptom scales to see if the drug helps where current treatments fall short.

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 (deuterated dextromethorphan/quinidine)
What this could lead to
If it works, this could offer a new option to ease negative symptoms like social withdrawal and lack of motivation in people with schizophrenia.
What could go wrong
This is an early Phase 2 trial with only 145 people, so results may not apply broadly. The drug may not work better than placebo or could cause side effects.

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

145 people

The number who actually took part.

Started

Sep 2015

Finished

Jul 2017

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 to 60 years

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: * Patients who meet DSM-IV-TR diagnostic criteria for schizophrenia using the M.I.N.I. version 6.0. * Patients must meet PANSS criteria * Patients currently receiving atypical antipsychotics are eligible provided they are on a stable dose Exclusion Criteria: * Patients with current major depressive disorder (MDD) * Patients with extrapyramidal syndrome secondary to their ongoing antipsychotic medication * Patients currently using anticholinergic medications * Recent in-patient hospitalization

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Conditions

The condition(s) this trial relates to.

schizophrenia

As listed by the trial registrant

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

Schizophrenia

Contacts and locations

Locations

  • Study site

    Cerritos, California, United States

  • Study site

    Garden Grove, California, United States

  • Study site

    National City, California, United States

  • Study site

    Oakland, California, United States

  • Study site

    San Diego, California, United States

  • Study site

    Washington D.C., District of Columbia, United States

  • Study site

    Orlando, Florida, United States

  • Study site

    Atlanta, Georgia, United States

  • Study site

    Augusta, Georgia, United States

  • Study site

    Chicago, Illinois, United States

  • Study site

    Boston, Massachusetts, United States

  • Study site

    Worcester, Massachusetts, United States

  • Study site

    Grand Rapids, Michigan, United States

  • Study site

    Marlton, New Jersey, United States

  • Study site

    Jamaica, New York, United States

  • Study site

    New York, New York, United States

  • Study site

    Rochester, New York, United States

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