Could adding abilify to antidepressants lift Treatment-Resistant depression?

NCT ID NCT00095758

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 phase 3 trial investigates whether adding aripiprazole (Abilify) to an antidepressant improves symptoms in adults with major depressive disorder who have not responded adequately to antidepressants alone. Participants take either aripiprazole or a placebo alongside their usual antidepressant for 6 weeks. The study measures changes in depression severity and daily functioning.

What this could mean

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

Active substance
aripiprazole (Abilify)
What this could lead to
If successful, this could offer a new option for people with major depression who do not get enough relief from antidepressants alone.
What could go wrong
This is a relatively short trial (6 weeks of treatment), and the added benefit over placebo may be modest. Aripiprazole can cause side effects like weight gain, restlessness, and sleepiness.

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

1,151 people

The number who actually took part.

Started

Sep 2004

Finished

Dec 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.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Local Institution

    Beverly Hills, California, United States

  • Local Institution

    Burbank, California, United States

  • Local Institution

    National City, California, United States

  • Local Institution

    Orange, California, United States

  • Local Institution

    Pasadena, California, United States

  • Local Institution

    Denver, Colorado, United States

  • Local Institution

    Farmington, Connecticut, United States

  • Local Institution

    Jacksonville, Florida, United States

  • Local Institution

    Orlando, Florida, United States

  • Local Institution

    Atlanta, Georgia, United States

  • Local Institution

    Rockville, Maryland, United States

  • Local Institution

    Albuquerque, New Mexico, United States

  • Local Institution

    Brooklyn, New York, United States

  • Local Institution

    New York, New York, United States

  • Local Institution

    Cincinnati, Ohio, United States

  • Local Institution

    Toledo, Ohio, United States

  • Local Institution

    Portland, Oregon, United States

  • Local Institution

    Pittsburgh, Pennsylvania, United States

  • Local Institution

    Memphis, Tennessee, United States

  • Local Institution

    Dallas, Texas, United States

  • Local Institution

    Houston, Texas, United States

  • Local Institution

    Arlington, Virginia, United States

  • Local Institution

    Herndon, Virginia, United States

  • Local Institution

    Richmond, Virginia, United States

  • Local Institution

    Bellevue, Washington, United States

  • Local Institution

    Seattle, Washington, United States

  • Local Institution

    Brown Deer, Wisconsin, United States

  • Local Institution

    Middleton, Wisconsin, United States

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