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Could adding aripiprazole to lamotrigine keep bipolar i patients stable?

NCT ID NCT00277212

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tested whether adding aripiprazole (Abilify) to the standard mood stabilizer lamotrigine helps prevent relapse in people with bipolar I disorder who recently had a manic or mixed episode. Over 1,100 adults took part, receiving either the combination or lamotrigine alone for up to 52 weeks. The goal was to see if the combination reduced the chance of another manic, mixed, or depressive episode.

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) and lamotrigine
What this could lead to
If it works, this combination could offer a more effective way to prevent manic or mixed episodes in people with bipolar I disorder.
What could go wrong
This is a completed phase 4 study, so results are already known. The benefit may be modest, and side effects from the drugs (e.g., weight gain, dizziness) are possible.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

1,169 people

The number who actually took part.

Started

Dec 2005

Finished

Jul 2009

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: * Men and women ≥ 18 years of age meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (Text Revision) (DSM-IV-TR) criteria for bipolar I disorder, recently experiencing a manic or mixed episode with a history of one or more manic or mixed episodes of sufficient severity to require treatment with a mood stabilizer or antipsychotic Exclusion Criteria: * First manic episode * Current manic or mixed episode with \> 2 years duration * Treated with aripiprazole within the past 3 months * Allergic, intolerant, hypersensitive or refractory to aripiprazole or lamotrigine

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Conditions

The condition(s) this trial relates to.

bipolar disorder bipolar I disorder

As listed by the trial registrant

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

Bipolar disorder

Contacts and locations

Locations

  • Act Clinical Research Institute, Llc

    Daytona Beach, Florida, 32124, United States

  • Alamo Superior Research

    San Antonio, Texas, 78229, United States

  • Aurora Health Care

    Milwaukee, Wisconsin, 53233, United States

  • Aurora-Cuervo Clinical Trials

    Miami, Florida, 33143, United States

  • Bayou City Research, Ltd.

    Houston, Texas, 77007, United States

  • Belmont Center For Comprehensive Treatment

    Philadelphia, Pennsylvania, 19131, United States

  • Buffalo Psychiatric Center

    Buffalo, New York, 14213, United States

  • Capital Clinical Research Associates

    Rockville, Maryland, 20852, United States

  • Clinco

    Terre Haute, Indiana, 47802, United States

  • Clinical Insights

    Glen Burnie, Maryland, 21061, United States

  • Clinical Research Institute

    Wichita, Kansas, 67213, United States

  • Clinical Trials Technology, Inc

    Prairie Village, Kansas, 66206, United States

  • Cns Clinical Research Group

    Coral Springs, Florida, 33065, United States

  • Cns Research Institute

    Philadelphia, Pennsylvania, 19149, United States

  • College Hospital Costa Mesa

    Costa Mesa, California, 92627, United States

  • Community Research

    Cincinnati, Ohio, 45227, United States

  • Comprehensive Neuroscience, Inc

    Atlanta, Georgia, 30328, United States

  • Cutting Edge Research

    Oklahoma City, Oklahoma, 73116, United States

  • Dubois Regional Medical Center

    DuBois, Pennsylvania, 15801, United States

  • Duke University Medical Center

    Durham, North Carolina, 27705, United States

  • Excell Research

    Oceanside, California, 92056, United States

  • Finger Lakes Clinical Research

    Rochester, New York, 14618, United States

  • Freimer, Martin

    East Stroudsburg, Pennsylvania, 18301, United States

  • Gulf Coast Medical Research

    Port Charlotte, Florida, 33952, United States

  • Harmony Research, Llc

    Piney Flats, Tennessee, 37686, United States

  • Health Research Center

    Morgantown, West Virginia, 26506, United States

  • Health Sciences America, Llc

    Boca Raton, Florida, 33432, United States

  • Horizon Medical Services

    Bismarck, North Dakota, 58501, United States

  • Janus Center For Psychiatric Research

    West Palm Beach, Florida, 33407, United States

  • Lehigh Center For Clinical Research

    Allentown, Pennsylvania, 18104, United States

  • Lehigh Valley Hospital

    Allentown, Pennsylvania, 18103, United States

  • Local Institution

    Cabo Rojo, 00623, Puerto Rico

  • Local Institution

    Ponce, 00731, Puerto Rico

  • Local Institution

    Rio Piedras, 00926, Puerto Rico

  • Local Institution

    San Juan, 00918, Puerto Rico

  • Los Angeles Biomedical Research Institute

    Torrance, California, 90502, United States

  • Neuro Behavioral Clinical Research, Inc.

    Canton, Ohio, 44708, United States

  • Neuropsychiatric Research Center Of Southwest Florida

    Fort Myers, Florida, 33912, United States

  • Owensboro Behavioral Care

    Owensboro, Kentucky, 42301, United States

  • Pacific Clinical Research Medical Group

    Upland, California, 91786, United States

  • Pacific Institute For Medical Research, Inc.

    Los Angeles, California, 90024, United States

  • Pacific Institute Of Medical Sciences

    Bothell, Washington, 98011, United States

  • Pravin Kansagra, M.D.

    Anaheim, California, 92801, United States

  • Precise Research Centers

    Flowood, Mississippi, 39232, United States

  • Psychiatric Consultants, Pc

    Nashville, Tennessee, 37203, United States

  • Psychopharmacology Research Corporation

    Farmington Hills, Michigan, 48334, United States

  • Regions Hospital

    Saint Paul, Minnesota, 55101, United States

  • Richmond Behavioral Associates

    Staten Island, New York, 10312, United States

  • Saroj Brar Md, Inc

    Cleveland, Ohio, 44113, United States

  • Sheppard Pratt Health System

    Baltimore, Maryland, 21285, United States

  • Southern Ca Clinical Research, Inc.

    Pasadena, California, 91106, United States

  • Southwest Biomedical Research Foundation

    Tucson, Arizona, 85712, United States

  • Stanford University

    Stanford, California, 94305, United States

  • Summit Research Network

    Portland, Oregon, 97210, United States

  • Summit Research Network (Seattle) Llc

    Seattle, Washington, 98104, United States

  • University Of Alabama At Birmingham

    Birmingham, Alabama, 35205, United States

  • University Of Kentucky, Dept. Of Psychiatry

    Lexington, Kentucky, 40509, United States

  • University Of Medicine & Dentistry Of New Jersey

    Cherry Hill, New Jersey, 08002, United States

  • University Of Minnesota

    Minneapolis, Minnesota, 55455, United States

  • University Of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104, United States

  • University Of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • University Of Virginia Health System

    Charlottesville, Virginia, 22903, United States

  • Ut Medical Group/Odyssey Research

    Memphis, Tennessee, 38105, United States

  • Valle Vista Health System

    Greenwood, Indiana, 46143, United States

  • Windwood Centre

    Virginia Beach, Virginia, 23452, United States

  • Zarzar Psychiatric Associates, Pllc

    Raleigh, North Carolina, 27607, United States

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