New hope for bipolar mania: KarXT enters final phase 3 trial

NCT ID NCT06951711

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

First seen Nov 01, 2025 · Last updated May 13, 2026 · Updated 23 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 an acute manic episode. About 274 participants will receive either KarXT or a placebo for 3 weeks while staying in the hospital. The goal is to see if KarXT safely and effectively eases manic symptoms better than a placebo.

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This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Contacts and locations

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Study contacts

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Locations

Arch Clinical Trials
RECRUITING

St Louis, Missouri, 63141, United States

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Atlanta Center for Medical Research
RECRUITING

Atlanta, Georgia, 30331, United States

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Be'er Sheva Mental Health Center
RECRUITING

Beersheba, Southern District, 8461144, Israel

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Behavioral Clinical Research
RECRUITING

Hollywood, Florida, 33021, United States

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CBH Health
RECRUITING

Gaithersburg, Maryland, 20877, United States

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CenExel iResearch, LLC
RECRUITING

Decatur, Georgia, 30030, United States

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

Bucharest, 060222, Romania

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Clinical Innovations, Inc. dba CITrials
RECRUITING

Riverside, California, 92506, United States

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Collaborative Neuroscience Research, LLC
RECRUITING

Torrance, California, 90502, United States

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Hassman Research Institute Marlton Site
RECRUITING

Marlton, New Jersey, 08053, United States

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Health Synergy Clinical Research
RECRUITING

West Palm Beach, Florida, 33407, United States

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Hospital Clínic de Barcelona
RECRUITING

Barcelona, Catalunya [Cataluña], 08036, Spain

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Hospital Universitari Vall d'Hebron
RECRUITING

Barcelona, Barcelona [Barcelona], 08035, Spain

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InSite Clinical Research
RECRUITING

DeSoto, Texas, 75115, United States

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Innovative Clinical Research, Inc.
RECRUITING

Miami Lakes, Florida, 33016, United States

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Kfar Shaul Mental Health Center
RECRUITING

Jerusalem, 9546105, Israel

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Klinika za psihijatriju "Vrapče"
RECRUITING

Zagreb, 10090, Croatia
Klinika za psihijatriju "Vrapče"
RECRUITING

Zagreb, 10090, Croatia

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LCC Medical Research Institute
RECRUITING

Miami, Florida, 33126, United States

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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

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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 - 0040
WITHDRAWN

Genova, 16132, Italy
Local Institution - 0041
WITHDRAWN

Ancona, 60126, Italy
Local Institution - 0047
NOT_YET_RECRUITING

Iași, 700282, Romania

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Local Institution - 0051
NOT_YET_RECRUITING

Ludhiana, Punjab, 141001, India

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Local Institution - 0052
NOT_YET_RECRUITING

Hyderabad, Telangana, 500034, India

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Local Institution - 0053
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Kozhikode, Kerala, 673009, India

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Local Institution - 0054
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Kolkata, West Bengal, 700014, India

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Local Institution - 0055
NOT_YET_RECRUITING

Hyderabad, Telangana, 500082, India

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Local Institution - 0056
WITHDRAWN

Pisa, Tuscany, 56126, Italy
Local Institution - 0058
NOT_YET_RECRUITING

Petah Tikva, Central District, 4910002, Israel

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Local Institution - 0065
NOT_YET_RECRUITING

Vadodara, Gujarat, 390021, India

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Local Institution - 0067
WITHDRAWN

Uppsala, Uppsala Län [se-03], 751 85, Sweden
Local Institution - 0070
WITHDRAWN

Gothenburg, Västra Götalands Län [se-14], 413 45, Sweden
Local Institution - 0071
NOT_YET_RECRUITING

Košice, Košice Region, 040 01, Slovakia

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Local Institution - 0072
NOT_YET_RECRUITING

Vranov nad Topľou, Presov, 093 01, Slovakia

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Local Institution - 0073
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Košice, Košice Region, 040 01, Slovakia

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Local Institution - 0075
WITHDRAWN

Charlotte, North Carolina, 28211, United States
Local Institution - 0076
WITHDRAWN

North Las Vegas, Nevada, 89030, United States
Local Institution - 0078
NOT_YET_RECRUITING

Zagreb, 10090, Croatia

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Local Institution - 0082
NOT_YET_RECRUITING

Belagavi, Karnataka, 590010, India

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Local Institution - 0085
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Vinnytsia, Vinnytsia Oblast, 21037, Ukraine

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Local Institution - 0088
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Dnipro, Dnipropetrovsk Oblast, 49115, Ukraine

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Local Institution - 0092
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Hlevakha, Kyiv Oblast, 08631, Ukraine

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Local Institution - 0093
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Oleksandrivka, Odesa Oblast, 67513, Ukraine

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Local Institution - 0094
NOT_YET_RECRUITING

Odesa, 65006, Ukraine

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Nacka Local Hospital
RECRUITING

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

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Ness Ziona Mental Health Center
RECRUITING

Ness Ziona, Central District, 7410001, Israel

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Neuro-Behavioral Clinical Research
RECRUITING

North Canton, Ohio, 44720, United States

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Osi Bilbao-Basurto
RECRUITING

Bilbao, Basque Country, 48013, Spain

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Pillar Clinical Research - Richardson
RECRUITING

Richardson, Texas, 75080, United States

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Pillar Clinical Research- Little Rock
RECRUITING

Little Rock, Arkansas, 72204, United States

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Precise Research Centers
RECRUITING

Flowood, Mississippi, 39232, United States

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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

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Proscience Research Group
RECRUITING

Culver City, California, 90230, United States

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Psihijatrijska bolnica "Sveti Ivan"
RECRUITING

Zagreb, 10090, Croatia

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Shalvata Mental Health Center
RECRUITING

Hod HaSharon, Central District, 4534708, Israel

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Sheba Medical Center
RECRUITING

Ramat Gan, Central District, 5265601, Israel

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South Florida Research Phase I-IV
RECRUITING

Miami Springs, Florida, 33166, United States

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Spitalul Universitar de Urgenta Militar Central Dr. Carol Davila
RECRUITING

Bucharest, 0, Romania

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Spitalul de Psihiatrie și Neurologie Brașov
RECRUITING

Sanpetru /Brasov, 507190, Romania

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University of Cincinnati Medical Center
RECRUITING

Cincinnati, Ohio, 45219, United States

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Woodland Research Northwest
RECRUITING

Rogers, Arkansas, 72758, United States

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Conditions

Explore the condition pages connected to this study.

BIPOLAR DISORDER TYPE I WITH MANIA OR MANIA WITH MIXED FEATURES