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New drug KarXT aims to tame bipolar mania in major trial

NCT ID NCT06951711

Symptom relief Sponsor: Bristol-Myers Squibb Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 04, 2026 · Updated 5 times

Summary

This study tests whether the drug KarXT can reduce symptoms of mania in people with Bipolar I disorder who are currently hospitalized for a manic episode. About 274 participants will receive either KarXT or a placebo for 3 weeks while staying in the hospital. The main goal is to see if KarXT improves manic symptoms better than a placebo.

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

About 274 people

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

Started

Jun 2025

Expected to finish

Nov 2026

An estimate. End dates often move.

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: * Participants must have a primary diagnosis of Bipolar-I disorder established by a comprehensive psychiatric evaluation. * Participants must be experiencing an acute episode or relapse of mania or mania with mixed features (≤ 3 weeks). * Participants must require hospitalization for the acute exacerbation or relapse of mania. * Participants must have all psychotropic medications washed out in no more than 14 days prior to the first dose of the study drug. * Participants must have a Young Mania Rating Scale (YMRS) score of ≥ 20 at Screening and at Baseline. * Participants must have a Clinical Global Impressions-Bipolar (CGI-BP) ≥ 4 at Screening and at Baseline. Exclusion Criteria: * Participants must not have any primary Diagnostic and Statistical Manual of Mental Disorders (5th Edition, Text Revision) (DSM-5-TR) disorder, other than BP-I with mania or mania with mixed features within 12 months before screening, including BP-I with depression (for previous 3 months only), BP-II disorder, borderline personality disorder, major depressive disorder, and primary psychotic disorder, with the exception of mild anxiety disorders. * Participants must not have a primary diagnosis of BP-I with rapid cycling (≥ 4 distinct mood episodes in one year). * Participants must not have a DSM-5-TR diagnosis of moderate to severe substance use disorder (except tobacco use disorder) within the 12 months before screening, or current use as determined by urine toxicology screen or alcohol test. * Participants must not be at risk for suicidal behavior at screening or the baseline visit as determined by the Investigator's clinical assessment and the Columbia-Suicide Severity Rating Scale (C-SSRS). * Participants must not have cirrhosis, liver cancer, clinically significant liver disease based on the liver function test results. * Other protocol-defined Inclusion/Exclusion criteria apply.

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Conditions

The condition(s) this trial relates to.

bipolar I disorder Mania

As listed by the trial registrant

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

Bipolar disorder type I with mania or mania with mixed features

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    68 sites in 9 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Adams Clinical Dallas

    RECRUITING

    DeSoto, Texas, 75115, United States

  • Arch Clinical Trials

    RECRUITING

    St Louis, Missouri, 63141, United States

  • Asha Hospital - Hyderabad

    RECRUITING

    Hyderabad, Telangana, 500034, India

  • Atlanta Center for Medical Research

    RECRUITING

    Atlanta, Georgia, 30331, United States

  • Be'er Sheva Mental Health Center

    RECRUITING

    Beersheba, Southern District, 8461144, Israel

  • Behavioral Clinical Research

    RECRUITING

    Hollywood, Florida, 33021, United States

  • CBH Health

    RECRUITING

    Gaithersburg, Maryland, 20877, United States

  • CenExel iResearch, LLC

    RECRUITING

    Decatur, Georgia, 30030, United States

  • Centrul de Evaluare și Tratament a Toxicodependenței pentru Tineri Sf.Stelian

    RECRUITING

    Bucharest, 060222, Romania

  • Chethana Center for Neuropsychiatry

    RECRUITING

    Kozhikode, Kerala, 673009, India

  • Clinical Innovations, Inc. dba CITrials

    RECRUITING

    Riverside, California, 92506, United States

  • Collaborative Neuroscience Research, LLC

    RECRUITING

    Torrance, California, 90502, United States

  • Crystal Comfort

    RECRUITING

    Vranov nad Topľou, Presov, 093 01, Slovakia

  • Dayanand Medical College and Hospital

    RECRUITING

    Ludhiana, Punjab, 141001, India

  • GMERS Medical College and General Hospital

    RECRUITING

    Vadodara, Gujarat, 390021, India

  • Hassman Research Institute Marlton Site

    RECRUITING

    Marlton, New Jersey, 08053, United States

  • Health Synergy Clinical Research

    RECRUITING

    West Palm Beach, Florida, 33407, United States

  • Innovative Clinical Research, Inc.

    RECRUITING

    Miami Lakes, Florida, 33016, United States

  • KLES Dr. Prabhakar Kore Hospital & M.R.C

    RECRUITING

    Belagavi, Karnataka, 590010, India

  • Kfar Shaul Mental Health Center

    RECRUITING

    Jerusalem, 9546105, Israel

  • Klinika za psihijatriju "Vrapče"

    RECRUITING

    Zagreb, 10090, Croatia

  • Klinika za psihijatriju "Vrapče"

    RECRUITING

    Zagreb, 10090, Croatia

  • Klinika za psihijatriju "Vrapče"

    RECRUITING

    Zagreb, 10090, Croatia

  • LCC Medical Research Institute

    RECRUITING

    Miami, Florida, 33126, United States

  • Local Institution - 0001

    WITHDRAWN

    Milan, Lombardy, 20122, Italy

  • Local Institution - 0007

    WITHDRAWN

    Siena, Tuscany, 53100, Italy

  • Local Institution - 0009

    WITHDRAWN

    Zagreb, City of Zagreb, 10090, Croatia

  • Local Institution - 0019

    WITHDRAWN

    Tampa, Florida, 33618, United States

  • Local Institution - 0020

    NOT_YET_RECRUITING

    Chicago, Illinois, 60640, United States

  • Local Institution - 0028

    WITHDRAWN

    Houston, Texas, 77021, United States

  • Local Institution - 0031

    WITHDRAWN

    Marlton, New Jersey, 08053, United States

  • Local Institution - 0036

    WITHDRAWN

    Hialeah Gardens, Florida, 33016, United States

  • Local Institution - 0039

    COMPLETED

    Bilbao, Basque Country, 48013, Spain

  • Local Institution - 0040

    WITHDRAWN

    Genova, 16132, Italy

  • Local Institution - 0041

    WITHDRAWN

    Ancona, 60126, Italy

  • Local Institution - 0044

    COMPLETED

    Barcelona, Catalunya [Cataluña], 08036, Spain

  • Local Institution - 0047

    NOT_YET_RECRUITING

    Iași, 700282, Romania

  • Local Institution - 0055

    NOT_YET_RECRUITING

    Hyderabad, Telangana, 500082, India

  • Local Institution - 0056

    WITHDRAWN

    Pisa, Tuscany, 56126, Italy

  • Local Institution - 0058

    NOT_YET_RECRUITING

    Petah Tikva, Central District, 4910002, Israel

  • Local Institution - 0067

    WITHDRAWN

    Uppsala, Uppsala Län [se-03], 751 85, Sweden

  • Local Institution - 0069

    COMPLETED

    Barcelona, Barcelona [Barcelona], 08035, Spain

  • Local Institution - 0070

    WITHDRAWN

    Gothenburg, Västra Götalands Län [se-14], 413 45, Sweden

  • Local Institution - 0073

    NOT_YET_RECRUITING

    Košice, Košice Region, 040 01, Slovakia

  • Local Institution - 0075

    WITHDRAWN

    Charlotte, North Carolina, 28211, United States

  • Local Institution - 0076

    WITHDRAWN

    North Las Vegas, Nevada, 89030, United States

  • Local Institution - 0084

    NOT_YET_RECRUITING

    Kropyvnytskyi, 25491, Ukraine

  • Local Institution - 0085

    NOT_YET_RECRUITING

    Vinnytsia, Vinnytsia Oblast, 21037, Ukraine

  • Local Institution - 0088

    NOT_YET_RECRUITING

    Dnipro, Dnipropetrovsk Oblast, 49115, Ukraine

  • Local Institution - 0090

    NOT_YET_RECRUITING

    Poltava, 36013, Ukraine

  • Local Institution - 0092

    NOT_YET_RECRUITING

    Hlevakha, Kyivska Oblast, 08631, Ukraine

  • Local Institution - 0093

    NOT_YET_RECRUITING

    Oleksandrivka, Odesa Oblast, 67513, Ukraine

  • Local Institution - 0094

    NOT_YET_RECRUITING

    Odesa, 65006, Ukraine

  • Local Institution - 0096

    NOT_YET_RECRUITING

    Kolkata, West Bengal, 700025, India

  • Local Institution - 0097

    NOT_YET_RECRUITING

    Bucharest, Bucharest, 11241, Romania

  • Local Institution - 0103

    NOT_YET_RECRUITING

    Beijing, Beijing Municipality, 100088, China

  • Local Institution - 0104

    NOT_YET_RECRUITING

    Tianjin, Tianjin Municipality, 300022, China

  • Local Institution - 0105

    NOT_YET_RECRUITING

    Jining Shi, Shandong, 272051, China

  • Local Institution - 0106

    NOT_YET_RECRUITING

    Beijing, Beijing Municipality, 100088, China

  • Local Institution - 0107

    NOT_YET_RECRUITING

    Changsha, Hunan, 410007, China

  • Local Institution - 0108

    NOT_YET_RECRUITING

    Wuhan, Hubei, 430012, China

  • Nacka Local Hospital

    RECRUITING

    Nacka, Stockholms Län [se-01], 131 45, Sweden

  • Ness Ziona Mental Health Center

    RECRUITING

    Ness Ziona, Central District, 7410001, Israel

  • Neuro-Behavioral Clinical Research

    RECRUITING

    North Canton, Ohio, 44720, United States

  • Nil Ratan Sircar Medical College and Hospital

    RECRUITING

    Kolkata, West Bengal, 700014, India

  • Pillar Clinical Research

    RECRUITING

    Richardson, Texas, 75080, United States

  • Pillar Clinical Research - Richardson

    RECRUITING

    Richardson, Texas, 75080, United States

  • Pillar Clinical Research- Little Rock

    RECRUITING

    Little Rock, Arkansas, 72204, United States

  • Precise Research Centers

    RECRUITING

    Flowood, Mississippi, 39232, United States

  • Prof. Dr. Alexandru Obregia Psychiatry Hospital

    RECRUITING

    Bucharest, Bucharest, 041914, Romania

  • Prof. Dr. Alexandru Obregia Psychiatry Hospital

    RECRUITING

    Bucharest, Bucharest, 041914, Romania

  • Prof. Dr. Alexandru Obregia Psychiatry Hospital

    RECRUITING

    Bucharest, Bucharest, 041914, Romania

  • Prof. Dr. Alexandru Obregia Psychiatry Hospital

    RECRUITING

    Bucharest, Bucharest, 041914, Romania

  • Prof. Dr. Alexandru Obregia Psychiatry Hospital

    RECRUITING

    Bucharest, Bucharest, 041914, Romania

  • Prof. Dr. Alexandru Obregia Psychiatry Hospital

    RECRUITING

    Bucharest, Bucharest, 041914, Romania

  • Proscience Research Group

    RECRUITING

    Culver City, California, 90230, United States

  • Psihijatrijska bolnica "Sveti Ivan"

    RECRUITING

    Zagreb, 10090, Croatia

  • Shalvata Mental Health Center

    RECRUITING

    Hod HaSharon, Central District, 4534708, Israel

  • Sheba Medical Center

    RECRUITING

    Ramat Gan, Central District, 5265601, Israel

  • South Florida Research Phase I-IV

    RECRUITING

    Miami Springs, Florida, 33166, United States

  • Spitalul Universitar de Urgenta Militar Central Dr. Carol Davila

    RECRUITING

    Bucharest, 0, Romania

  • Spitalul de Psihiatrie și Neurologie Brașov

    RECRUITING

    Sanpetru /Brasov, 507190, Romania

  • University of Cincinnati Medical Center

    RECRUITING

    Cincinnati, Ohio, 45219, United States

  • Univerzitna Nemocnica L. Pasteura Kosice

    RECRUITING

    Košice, Košice Region, 040 01, Slovakia

  • Woodland Research Northwest

    RECRUITING

    Rogers, Arkansas, 72758, United States