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Real-World study shows cariprazine eases depression in bipolar i patients

NCT ID NCT06256367

Symptom relief Sponsor: AbbVie 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 followed 120 adults with bipolar I disorder who were having a major depressive episode and starting cariprazine (Vraylar). Researchers measured changes in depression symptoms, daily functioning, and quality of life over 24 weeks in a real-world clinic setting. The goal was to see how well the medication works outside of strict clinical trials.

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.

Participants

120 people

The number who actually took part.

Started

Apr 2024

Finished

Jan 2026

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.

Who is studied

Patients with a bipolar I disorder diagnosis experiencing a major depressive episode (with or without mixed features) requiring treatment and being prescribed cariprazine by their physician; irrespective of study participation.

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: * Have a physician-confirmed diagnosis of BP-I, with or without comorbidities. * Prescribed cariprazine as part of routine clinical practice with the intention of treating as per the approved market label, respective country indications, and by the physician under usual and customary practice of physician prescription. * Have a Montgomery-Åsberg Depression Rating Scale (MADRS) score \>= 20 at baseline. * Have a Functioning Assessment Short Test (FAST) score \>= 21 at baseline. * Naïve to cariprazine in the current major depressive episode. Exclusion Criteria: * Have a medical or psychiatric condition, or planned surgical procedure, which will interfere with study participation, as judged by the investigator. * Have a known contraindication to cariprazine including any of the following: * Hypersensitivity to cariprazine or any ingredient in the formulation * For all sites, concomitant use of strong cytochrome P450 (CYP) 3A4 inhibitors and inducers * For Canadian sites, as per country label, concomitant use of moderate CYP 3A4 inhibitors and inducers * Current major depressive episode duration \> 12 months.

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Conditions

The condition(s) this trial relates to.

bipolar I disorder

As listed by the trial registrant

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

Bipolar I disorder

Contacts and locations

Locations

  • Betts Psychiatric, PC /ID# 259737

    Eugene, Oregon, 97401-6008, United States

  • Bowman Medical Group /ID# 259989

    Beverly Hills, California, 90212-1910, United States

  • Chatham-Kent Clinical Trials /ID# 262414

    Chatham, Ontario, N7L 1C1, Canada

  • Clinique Woodward /ID# 264050

    Sherbrooke, Quebec, J1G 2N5, Canada

  • Douglas Mental Health University Institute /ID# 262048

    Verdun, Quebec, H4H 1R2, Canada

  • Georgia Psychiatric Consultants & Advanced Discovery Research /ID# 259975

    Atlanta, Georgia, 30318-3102, United States

  • Grand River Hospital /ID# 263962

    Kitchener, Ontario, N2G 1G3, Canada

  • Institut universitaire en santé mentale de Montréal /ID# 264665

    Montreal, Quebec, H1N 3M5, Canada

  • Montano Wellness LLC /ID# 259837

    Cromwell, Connecticut, 06416, United States

  • North Star Medical Research LL /ID# 259730

    Middleburg Heights, Ohio, 44130, United States

  • Omaha Insomnia and Psychiatric Services /ID# 259961

    Omaha, Nebraska, 68144-2359, United States

  • Quest Therapeutics of Avon /ID# 259838

    Avon Lake, Ohio, 44012-1004, United States

  • Rivus Wellness And Research Institute /ID# 259966

    Oklahoma City, Oklahoma, 73112, United States

  • START Clinic for Mood and Anxiety Disorders /ID# 262416

    Toronto, Ontario, M4W 2N4, Canada

  • Southlake Regional Health Centre /ID# 264212

    Newmarket, Ontario, L3Y 2P9, Canada

  • Sunny Johnson Medical Research Associates /ID# 267713

    Mississauga, Ontario, L5M 4N4, Canada

  • UC Davis /ID# 259723

    Sacramento, California, 95817-2310, United States

  • University of Alabama at Birmingham - Main /ID# 260000

    Birmingham, Alabama, 35233, United States

  • Ut Southwestern Medical Center /Parkland Health and Hospital System /Id# 260001

    Dallas, Texas, 75235-7709, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.