New hope for bipolar mania: KarXT trial launches

NCT ID NCT07140913

Disease control Sponsor: Bristol-Myers Squibb Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether adding KarXT to standard mood stabilizers (lithium, valproate, or lamotrigine) helps control manic episodes in people with bipolar I disorder. About 424 adults hospitalized for mania will receive either KarXT or a placebo for 5 weeks. The main goal is to see if mania symptoms improve more with KarXT.

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 424 people

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

Started

Oct 2025

Expected to finish

Jun 2027

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: * Individuals have a primary diagnosis of Bipolar-I disorder established by a comprehensive psychiatric evaluation based on the DSM-5-TR criteria and confirmed by the Mini International Neuropsychiatric Interview (MINI) version 7.0.2. * Individual is experiencing an acute exacerbation or relapse of manic episode, with or without mixed features (≤ 3 weeks). * The individual requires hospitalization for the acute exacerbation or relapse of mania. * Body mass index ≥ 18 and ≤ 40 kg/m2. * Currently experiencing an acute episode of mania or mania with mixed features with a therapeutic dose of lithium, valproate, or lamotrigine. The dose of the mood stabilizer must have remained stable for at least two weeks prior to screening. Additionally, participants on valproate must have been receiving treatment with valproate for a minimum of seven months. * YMRS Total Score of ≥ 18 at Screening and at Baseline, and \< 20% reduction in YMRS from screening to baseline. Exclusion Criteria: * Any primary DSM-5-TR disorder other than BP-I within 12 months before screening (confirmed using MINI version 7.0.2 at screening) including BP-I depression (for previous 3 months only), BP-I with rapid cycling, first manic episode, BP-II, primary psychotic disorder, borderline personality disorder, and major depressive disorder, with the exception of mild anxiety disorders. * Individual has a DSM-5-TR diagnosis of moderate to severe substance use disorder (except tobacco use disorder) within the 12 months before screening (confirmed using MINI version 7.0.2 at screening), or current use as determined by urine toxicology screen or alcohol test. * Risk for suicidal behavior at screening as determined by the investigator's clinical assessment and the C-SSRS with an answer "Yes" to item 4 or 5 within 6 months before screening or between screening and baseline, or "Yes" to any of the 5 items (C-SSRS behavior) with an event occurring within the 12 months before screening, or between screening and baseline. * History of irritable bowel syndrome (with or without constipation) or any serious constipation requiring treatment within the last 6 months. * History or high risk of urinary retention, gastric retention, or narrow-angle glaucoma. * Participants with HIV, cirrhosis, biliary duct abnormalities, hepatobiliary carcinoma, and/or active hepatic viral infections based on either medical history or the LFT results. * Elevations in hepatic transaminases at screening ≥ 2 × ULN for ALT or AST and/or bilirubin \> 1.5× ULN, unless in the context of Gilbert's syndrome. * All grades of hepatic impairment (mild \[Child-Pugh Class A\], moderate \[Child-Pugh Class B\], and severe \[Child-Pugh Class C\]). * Other protocol-defined Inclusion/Exclusion criteria apply.

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Conditions

The condition(s) this trial relates to.

bipolar disorder bipolar I disorder Mania

As listed by the trial registrant

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

Bipolar disorder Mania

How to take part

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

The places running it

100 sites in 13 countries. The list below names each one and where it is.
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 ↗
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

"University Multiprofile Hospital for Active Treatment - Dr. Georgi Stranski" EAD
RECRUITING

Pleven, 5800, Bulgaria
Arch Clinical Trials
RECRUITING

St Louis, Missouri, 63141, United States
Azienda Ospedaliero Universitaria Senese
RECRUITING

Siena, Tuscany, 53100, Italy
Be'er Sheva Mental Health Center
RECRUITING

Beersheba, Southern District, 8461144, Israel
Catalina Research Institute, LLC
RECRUITING

Montclair, California, 91763, United States
CenExel iResearch, LLC
RECRUITING

Savannah, Georgia, 31405, United States
Clinica Inventiva
RECRUITING

Tuszyn, 95-080, Poland
Clinical Innovations, Inc. dba CITrials
RECRUITING

Bellflower, California, 90706, United States
Clinical Innovations, Inc. dba CITrials
RECRUITING

Riverside, California, 92506, United States
Community Clinical Research
RECRUITING

Austin, Texas, 78754, United States
Elevate Clinical Research-Houston
RECRUITING

Houston, Texas, 77058, United States
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
RECRUITING

Milan, Lombardy, 20122, Italy
Goryokai Medical Corporation - Goryokai Hospital
RECRUITING

Sapporo, Hokkaido, 002-8029, Japan
Health Synergy Clinical Research
RECRUITING

West Palm Beach, Florida, 33407, United States
Inland Psychiatric Medical Group.
RECRUITING

Chino, California, 91710, United States
Institutul Național de Gerontologie și Geriatrie "Ana Aslan"
RECRUITING

Bucharest, 011241, Romania
Instytut Psychiatrii i Neurologii
RECRUITING

Warsaw, Masovian Voivodeship, 02-957, Poland
Juntendo University Hospital
RECRUITING

Bunkyo-ku, Tokyo, 113-8431, Japan
Kochi Health Sciences Center
RECRUITING

Kochi, 781-8555, Japan
Kuramitsu Hospital
RECRUITING

Fukuoka, 819-0037, Japan
Local Institution - 0002
NOT_YET_RECRUITING

Genova, 16132, Italy
Local Institution - 0004
NOT_YET_RECRUITING

Ancona, 60126, Italy
Local Institution - 0005
NOT_YET_RECRUITING

Pisa, Tuscany, 56126, Italy
Local Institution - 0008
NOT_YET_RECRUITING

Córdoba, X5003DCE, Argentina
Local Institution - 0009
NOT_YET_RECRUITING

Mendoza, 5502, Argentina
Local Institution - 0010
NOT_YET_RECRUITING

Córdoba, 5000, Argentina
Local Institution - 0011
NOT_YET_RECRUITING

ABB, Buenos Aires F.D., C1199ABB, Argentina
Local Institution - 0012
NOT_YET_RECRUITING

Córdoba, 5000, Argentina
Local Institution - 0052
NOT_YET_RECRUITING

Hod HaSharon, Central District, 4534708, Israel
Local Institution - 0053
NOT_YET_RECRUITING

Ashkelon, Southern District, 7830604, Israel
Local Institution - 0054
NOT_YET_RECRUITING

Aalborg, North Denmark, 9000, Denmark
Local Institution - 0083
NOT_YET_RECRUITING

Jerusalem, 9112001, Israel
Local Institution - 0085
NOT_YET_RECRUITING

Clermont-Ferrand, Puy-de-Dôme, 63000, France
Local Institution - 0086
NOT_YET_RECRUITING

Targovishte, 7700, Bulgaria
Local Institution - 0087
WITHDRAWN

Marseille, 13274, France
Local Institution - 0088
NOT_YET_RECRUITING

Hillerød, Capital Region, 3400, Denmark
Local Institution - 0089
WITHDRAWN

Paris, 75014, France
Local Institution - 0091
NOT_YET_RECRUITING

Glostrup Municipality, 2600, Denmark
Local Institution - 0093
NOT_YET_RECRUITING

Bucharest, Bucharest, 041914, Romania
Local Institution - 0097
NOT_YET_RECRUITING

Iași, 700282, Romania
Local Institution - 0099
NOT_YET_RECRUITING

Bucharest, 0, Romania
Local Institution - 0101
NOT_YET_RECRUITING

Sibiu, 550082, Romania
Local Institution - 0103
NOT_YET_RECRUITING

Rybnik, Silesian Voivodeship, 44-200, Poland
Local Institution - 0107
NOT_YET_RECRUITING

Yokohama, Kanagawa, 234-0051, Japan
Local Institution - 0114
NOT_YET_RECRUITING

Santiago del Estero, 4200, Argentina
Local Institution - 0116
NOT_YET_RECRUITING

Kolkata, 700014, India
Local Institution - 0118
NOT_YET_RECRUITING

Kolkata, West Bengal, 700025, India
Local Institution - 0121
NOT_YET_RECRUITING

Mangalore, Karnataka, 575003, India
Local Institution - 0123
NOT_YET_RECRUITING

Madurai, Tamil Nadu, 625020, India
Local Institution - 0126
NOT_YET_RECRUITING

Nice, Alpes-Maritimes, 06000, France
Local Institution - 0129
NOT_YET_RECRUITING

Montpellier, 34295, France
Local Institution - 0141
WITHDRAWN

Kitakyushu-shi, Fukuoka, 8078555, Japan
Local Institution - 0162
NOT_YET_RECRUITING

Kyiv, Kyivska Oblast, 04080, Ukraine
Local Institution - 0163
NOT_YET_RECRUITING

Nove, Kirovohrad Oblast, 25491, Ukraine
Local Institution - 0164
NOT_YET_RECRUITING

Lviv, Lviv Oblast, 79021, Ukraine
Local Institution - 0165
NOT_YET_RECRUITING

Dnipro, Dnipropetrovsk Oblast, 49005, Ukraine
Local Institution - 0167
NOT_YET_RECRUITING

Smila, Cherkasy Oblast, 20708, Ukraine
Local Institution - 0168
NOT_YET_RECRUITING

Vinnytsia, Vinnytsia Oblast, 21037, Ukraine
Local Institution - 0169
NOT_YET_RECRUITING

Hlevakha, Kyivska Oblast, 08631, Ukraine
Local Institution - 0170
NOT_YET_RECRUITING

Odesa, Odesa Oblast, 67513, Ukraine
Local Institution - 0171
NOT_YET_RECRUITING

Odesa, 65006, Ukraine
Local Institution - 0172
WITHDRAWN

Iizuka, Fukuoka, 820-8505, Japan
Local Institution - 0177
NOT_YET_RECRUITING

Poltava, 36000, Ukraine
Local Institution - 0178
NOT_YET_RECRUITING

Skarzhyntsi, Khmelnytskyi Oblast, 32120, Ukraine
Local Institution - 0181
NOT_YET_RECRUITING

Sliven, 8800, Bulgaria
Local Institution - 0184
NOT_YET_RECRUITING

Kazanlak, Stara Zagora, 6100, Bulgaria
Local Institution - 0185
NOT_YET_RECRUITING

Beijing, Beijing Municipality, 100088, China
Local Institution - 0186
NOT_YET_RECRUITING

Xi'an, Shaanxi, 710061, China
Local Institution - 0187
NOT_YET_RECRUITING

Shijiazhuang, Hebei, 050031, China
Local Institution - 0188
NOT_YET_RECRUITING

Tianjin, Tianjin Municipality, 300022, China
Local Institution - 0190
NOT_YET_RECRUITING

Beijing, Beijing Municipality, 100096, China
Local Institution - 0191
NOT_YET_RECRUITING

Guangzhou, Guangdong, 510370, China
Local Institution - 0192
NOT_YET_RECRUITING

Chengdu, Sichuan, 610036, China
Local Institution - 0193
NOT_YET_RECRUITING

Baoding, Hebei, 071000, China
Local Institution - 0195
NOT_YET_RECRUITING

Changsha, 450052, China
Local Institution - 0196
NOT_YET_RECRUITING

Nanjing, Jiangsu, 210029, China
Local Institution - 0197
NOT_YET_RECRUITING

Ningbo, Zhejiang, 315201, China
Local Institution - 0201
NOT_YET_RECRUITING

Kodaira, Tokyo, 187-8551, Japan
Local Institution - 0203
NOT_YET_RECRUITING

Bucharest, 41914, Romania
Local Institution - 0205
NOT_YET_RECRUITING

Ichikawa, Chiba, 272-8516, Japan
Local Institution - 0206
NOT_YET_RECRUITING

Ternopil, 46027, Ukraine
NRC Research Institute
RECRUITING

Orange, California, 92868, United States
Narimasu Kosei Hospital
RECRUITING

tabashi City, Tokyo, 175-0091, Japan
Nippon Medical School Hospital
RECRUITING

Bunkyo-ku, Tokyo, 1138603, Japan
Okehazama Hospital
RECRUITING

Toyoake, Aichi-ken, 470-1168, Japan
Omega Clinical Trials - La Habra
RECRUITING

La Habra, California, 90631, United States
Pillar Clinical Research - Bentonville
RECRUITING

Bentonville, Arkansas, 72712, United States
Pillar Clinical Research - Richardson
RECRUITING

Richardson, Texas, 75080, United States
Pillar Clinical Research -Chicago
RECRUITING

Chicago, Illinois, 60641, United States
Pillar Clinical Research- Little Rock
RECRUITING

Little Rock, Arkansas, 72204, United States
Prime Clinical Research - Mansfield
RECRUITING

Mansfield, Texas, 76063, 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
Proscience Research Group
RECRUITING

Culver City, California, 90230, United States
Rainbow and Sea Hospital
RECRUITING

Karatsu, Saga-ken, 847-0031, Japan
Richmond Behavioral Associates
RECRUITING

Staten Island, New York, 10314, United States
Sheba Medical Center
RECRUITING

Ramat Gan, Central District, 5265601, Israel
South Florida Research Phase I-IV
RECRUITING

Miami, Florida, 33166, United States
Spitalul de Psihiatrie și Neurologie Brașov
RECRUITING

Sanpetru /Brasov, 507190, Romania
State Psychiatric Hospital Sv. Ivan Rilski Novi Iskar
RECRUITING

Novi Iskar, 1282, Bulgaria
Uniwersyteckie Centrum Kliniczne
RECRUITING

Gdansk, Pomeranian Voivodeship, 80-214, Poland
Velocity Clinical Research, Hallandale Beach
RECRUITING

Hallandale, Florida, 33009, United States

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