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Which pill works best for bipolar depression? huge study aims to find out

NCT ID NCT06433635

Disease control Sponsor: Massachusetts General Hospital 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This large study compares four FDA-approved medications for bipolar depression to see which one helps people feel better. Over 2,700 adults with bipolar I or II disorder and current depression will be randomly assigned to one of the drugs. The goal is to find which treatment leads to remission, meaning fewer depressive symptoms and improved well-being.

What this could mean

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

Active substance
Cariprazine, Quetiapine, Lurasidone, Aripiprazole/Escitalopram
What this could lead to
If successful, this trial could identify which medication is most effective for treating bipolar depression, helping doctors choose better treatments.
What could go wrong
This is a pragmatic trial comparing existing drugs, so no new breakthrough is expected. Results may not apply to all patients, and side effects like nausea or sedation 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

About 2,726 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

Feb 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 to 75 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: 1. Aged between 18 years to 75 years 2. Meets criteria for DSM-V Bipolar I or II disorder with a history of manic or hypomanic episodes and current major depressive episode lasting at least 2 weeks 3. Can be managed as an outpatient and participate in the study 4. Willing to be randomized; able to perform study assessments 5. Women of childbearing potential must agree to use adequate contraception (e.g. oral contraceptives, intrauterine device, barrier methods, or total abstinence; Depo Provera is acceptable if it is started 3 months prior to enrollment), and inform staff of their plans to conceive. Exclusion Criteria: 1. Meets current criteria for a manic episode, rapid cycling within the past year (history of 4 or more mood episodes per year) 2. History of schizophrenia or other nonaffective psychosis 3. Current substance use disorder that will interfere with participation in the study 4. Currently taking the study medications or a history of serious adverse events to any of the study medications, to the extent that as determined by site PI, another trial would not be clinically indicated 5. A history of non-response for depressive episodes, to any of the study medications, when given at adequate doses for at least 6 weeks 6. Current acute suicidal risk that requires inpatient treatment 7. Pregnancy or breastfeeding

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Conditions

The condition(s) this trial relates to.

bipolar I disorder bipolar II disorder Depression depressive disorder major depressive disorder

As listed by the trial registrant

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

Bipolar I disorder Depression

Contacts and locations

Locations

  • Case Western Reserve University

    Cleveland, Ohio, 44106-1712, United States

  • John Hopkins

    Baltimore, Maryland, 21218, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • McLean Hospital

    Belmont, Massachusetts, 02478, United States

  • Montefiore Medical Center and Albert Einstein College of Medicine

    New York, New York, 10461, United States

  • Nagy Youssef

    Grand Rapids, Michigan, 49548, United States

  • New York University Grossman School of Medicine NYU

    New York, New York, 10016, United States

  • Steve Strakowski

    Bloomington, Indiana, 47405, United States

  • UT Health Houston Texas

    Houston, Texas, 77030, United States

  • UT Southwestern Medical Center

    Dallas, Texas, 75390-7208, United States

  • University of Alabama Birmingham

    Birmingham, Alabama, 35294, United States

  • University of British Columbia

    Vancouver, British Columbia, V6T 1Z4, Canada

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • University of New Mexico Health Sciences Center Albuquerque

    Albuquerque, New Mexico, 87131-0001, United States

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15260, United States

  • University of Texas at Austin

    Austin, Texas, 78712, United States

More trials for these conditions

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