Taking people in HungaryPhase 3
Tests KarXT for manic episodes in bipolar I disorder
Tests KarXT against placebo in adults with bipolar I manic episodes.
Key facts
- Who runs it
- Bristol-Myers Squibb
- Where
- Budapest and Győr, HungarySee the 3 sitesAlso in 8 other countries, 71 sites
- Trial code
- NCT06951698
- EudraCT 2024-520165-32
- U1111-1316-7438
- Registry title
- A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 274 people, planned
- Started
- 11 Jun 2025
- Planned end
- 1 Nov 2026
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- KarXT
- Placebo
- Record updated
- 23 October 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 aged 18 to 65 with Bipolar-I disorder who are in a manic episode that needs hospital care.
- Age
- 18 to 65 years
- Sex
- All sexes can join.
- Disease stage
- Bipolar-I disorder with an acute manic episode or mania with mixed features (3 weeks or less). Hospital care is needed. YMRS score of 20 or more and CGI-BP of 4 or more at screening and baseline.
- Earlier treatment
- All psychotropic medicines must be washed out no more than 14 days before the first dose of the study drug.
Main reasons for not taking part
- Any other main mental disorder, such as Bipolar-II, major depression, borderline personality disorder or a primary psychotic disorder (mild anxiety disorders are allowed)
- Bipolar-I with rapid cycling (4 or more distinct mood episodes in one year)
- Moderate to severe substance use disorder (except tobacco), or current substance use on testing
- Risk of suicidal behavior
- History or high risk of urinary retention, gastric retention or untreated narrow-angle glaucoma
The registry criteria, word for word
Show all 13 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 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
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 Hungary
Also in 8 other countries, 71 sites
- Nyírő Gyula Országos Pszichiátriai és Addiktológiai IntézetBudapest, HungaryContact: Csaba Almasi, Site 0114Taking people
- Semmelweis EgyetemBudapest, HungaryContact: János Réthelyi, Site 0118Taking people
- Petz Aladar Egyetemi Oktato KorhazGyőr, HungaryContact: Gabor Feller, Site 0116Taking people
About the trial
What the trial wants to find out
The purpose of this study is to evaluate the efficacy and safety of KarXT for the treatment of manic episodes in Bipolar-I Disorder
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-1)
- Plain-language title
- Tests KarXT 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 NCT06951698, who can take part
- Record updated
- 23 October 2026