Tests KarXT for manic episodes in bipolar I disorder
Tests KarXT against placebo in adults with bipolar I manic episodes.
Plain-language title generated from the registry record
Registry title: A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder
Key facts
- Where
- Fukuoka, Ichikawa, Iruma, Karatsu-shi, Kitakyushu, Kodaira, Kōnan, Kumagaya, Miyazaki, Moriguchi, Obihiro, Osaka, Sapporo, tabashi City, Tokyo, Toyoake, Wakayama, and Yamagata, JapanSee the 19 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT06951698, who can take part
Where in Japan
- Kuramitsu HospitalFukuoka, JapanTaking people
- National Kohnodai Medical Center.Ichikawa, JapanTaking people
- IrumaIruma, JapanNo longer taking part
- Rainbow and Sea HospitalKaratsu-shi, JapanTaking people
- KitakyushuKitakyushu, JapanNo longer taking part
- National Center of Neurology and PsychiatryKodaira, JapanTaking people
- KōnanKōnan, JapanNo longer taking part
- Saitama Konan HospitalKumagaya, JapanTaking people
- Miyazaki Prefectural Miyazaki HospitalMiyazaki, JapanTaking people
- Kansai Medical University Medical CenterMoriguchi, JapanTaking people
- Obihiro Kosei HospitalObihiro, JapanTaking people
- Osaka Metropolitan University HospitalOsaka, JapanTaking people
- OsakaOsaka, JapanNo longer taking part
- Goryokai Medical Corporation - Goryokai HospitalSapporo, JapanTaking people
- Narimasu Kosei Hospitaltabashi City, JapanTaking people
- Showa Medical University Karasuyama HospitalTokyo, JapanTaking people
- Okehazama HospitalToyoake, JapanTaking people
- Wakayama Medical University HospitalWakayama, JapanTaking people
- Yamagata Sakuracho HospitalYamagata, JapanTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Bristol-Myers Squibb
- Trial code
- NCT06951698
- Record updated
- 23 October 2026
- Original description
The purpose of this study is to evaluate the efficacy and safety of KarXT for the treatment of manic episodes in Bipolar-I DisorderRead full original descriptionShow less
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-1)
The purpose of this study is to evaluate the efficacy and safety of KarXT for the treatment of manic episodes in Bipolar-I Disorder
Inclusion: 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: 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 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 have a history of irritable bowel syndrome (with or without constipation) or serious constipation requiring treatment within the last 6 months; Participants must not have a primary diagnosis of BP-I with rapid cycling (≥ 4 distinct mood episodes in one year); 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 a history or high risk of urinary retention, gastric retention, or untreated narrow-angle glaucoma; Other protocol-defined Inclusion/Exclusion criteria apply.