Taking people in IndiaPhase 3
KarXT tested against placebo for manic episodes in bipolar I disorder
Tests KarXT against placebo in adults hospitalized with a manic episode of bipolar I disorder.
Key facts
- Who runs it
- Bristol-Myers Squibb
- Where
- Belagavi, Hyderabad, Kolkata, Kozhikode, Ludhiana, Madurai, Vadodara, and Visakhapatnam, IndiaSee the 9 sitesAlso in 10 other countries, 70 sites
- Trial code
- NCT06951711
- EudraCT 2024-520195-94
- U1111-1316-7466
- Registry title
- A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-2)
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 274 people, planned
- Started
- 13 Jun 2025
- Planned end
- 2 Nov 2026
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- KarXT
- Placebo
- Record updated
- 10 November 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults hospitalized with a manic episode of bipolar-I disorder. It tests KarXT against placebo over 3 weeks in hospital.
- Age
- 18 Years to 65 Years
- Sex
- All sexes
- Disease stage
- Acute episode or relapse of mania or mania with mixed features (≤ 3 weeks), needing hospitalization, with a primary diagnosis of Bipolar-I disorder.
- Earlier treatment
- All psychotropic medications must be washed out in no more than 14 days before the first dose of the study drug.
- Biomarker or test result
- Young Mania Rating Scale (YMRS) score of ≥ 20 and Clinical Global Impressions-Bipolar (CGI-BP) ≥ 4, both at Screening and at Baseline.
Main reasons for not taking part
- Another primary mental disorder, such as BP-II disorder, major depressive disorder or a primary psychotic disorder (mild anxiety disorders are allowed)
- Bipolar-I with rapid cycling (≥ 4 distinct mood episodes in one year)
- Moderate to severe substance use disorder (except tobacco) in the past 12 months, or current use
- Risk of suicidal behavior at screening or baseline
- Cirrhosis, liver cancer or clinically significant liver disease
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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 cirrhosis, liver cancer, clinically significant liver disease based on the liver function test results
- 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)
- Other protocol-defined Inclusion/Exclusion criteria apply
Check if you might fit
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?
Where in India
Also in 10 other countries, 70 sites
- KLES Dr. Prabhakar Kore Hospital & M.R.CBelagavi, IndiaContact: Bheemsain Tekkalaki, Site 0082Taking people
- Hyderabad, TelanganaHospital not named in the registryContact: Site 0055Not yet recruiting
- Asha Hospital - HyderabadHyderabad, IndiaContact: G Rao, Site 0052Taking people
- Nil Ratan Sircar Medical College and HospitalKolkata, IndiaContact: Asish Mukhopadhyay, Site 0054Taking people
- Chethana Center for NeuropsychiatryKozhikode, IndiaContact: SURESHKUMAR N, Site 0053Taking people
- Dayanand Medical College and HospitalLudhiana, IndiaContact: Navkiran Mahajan, Site 0051Taking people
- Madurai, Tamil NaduHospital not named in the registryContact: Site 0098Not yet recruiting
- GMERS Medical College and General HospitalVadodara, IndiaContact: Sandip Shah, Site 0065Taking people
- Visakhapatnam, Andhra PradeshHospital not named in the registryContact: Site 0099Not yet recruiting
About the trial
What the trial wants to find out
This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, inpatient study in participants with bipolar disorder experiencing an acute episode of mania or mania with mixed features.
Read full original descriptionShow less
The primary objective of the study is to evaluate the efficacy of KarXT compared to placebo in treating symptoms of mania during a 3-week inpatient period. The duration of the study including screening, the double-blind inpatient treatment period and safety-follow-up is no more than seven weeks.
The 2 groups in the trial
- KarXTTreatment being tested
Flexible dosing
- PlaceboPlacebo, for comparison
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 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-2)
- Plain-language title
- KarXT tested against placebo for manic episodes in bipolar I disorderGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT06951711, who can take part
- Record updated
- 10 November 2026