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Can an antipsychotic boost antidepressants for Hard-to-Treat depression?

NCT ID NCT00095823

NEW 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Oct 13, 2026 · Last updated Oct 13, 2026

Summary

Researchers are testing whether adding aripiprazole, an antipsychotic also known as Abilify, to an ongoing antidepressant helps adults with major depressive disorder who have not responded well to antidepressants alone. The trial enrolls about 1,200 men and women aged 18 to 65 who have had a depressive episode for at least 8 weeks and whose symptoms did not improve enough on one to three antidepressants. Participants take either aripiprazole or a placebo alongside their current antidepressant for 6 weeks, after an 8-week baseline phase. The study measures changes in depression, disability, and overall clinical impression.

What this could mean

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

Active substance
aripiprazole, an antipsychotic medicine also known as Abilify, added to an ongoing antidepressant
What this could lead to
If it works, adding aripiprazole could become a standard option for people whose depression does not improve enough on an antidepressant alone.
What could go wrong
Aripiprazole can cause weight gain, restlessness, and other side effects, and adding a second medicine may not help everyone. Results from this trial may not apply to all people with depression.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

1,200 people

Start date

Jun 2004

Finished

Aug 2006

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 65 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: * Men and women, 18-65 years old * Experienced a Major Depressive Disorder with the current episode of minimally 8 weeks in duration. * Treatment history of an inadequate response to at least one and no more than three antidepressants.

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Conditions

The condition(s) this trial relates to.

major depressive disorder

As listed by the trial registrant

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

Major depressive disorder

Contacts and locations

Locations

  • Local Institution

    Garden Grove, California, United States

  • Local Institution

    Northridge, California, United States

  • Local Institution

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

  • Local Institution

    Jacksonville, Florida, United States

  • Local Institution

    Chicago, Illinois, United States

  • Local Institution

    Edwardsville, Illinois, United States

  • Local Institution

    Rockville, Maryland, United States

  • Local Institution

    Springfield, Massachusetts, United States

  • Local Institution

    Farmington Hills, Michigan, United States

  • Local Institution

    Okemos, Michigan, United States

  • Local Institution

    Staten Island, New York, United States

  • Local Institution

    Portland, Oregon, United States

  • Local Institution

    Philadelphia, Pennsylvania, United States

  • Local Institution

    Austin, Texas, United States

  • Local Institution

    Salt Lake City, Utah, United States

  • Local Institution

    Woodstock, Vermont, United States

  • Local Institution

    Charlottesville, Virginia, United States

  • Local Institution

    Bellevue, Washington, United States

  • Local Institution

    Seattle, Washington, United States

  • Local Institution

    Middleton, Wisconsin, United States

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