Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
Phase 3: testing KarXT for Bipolar Disorder Type I With Mania or Mania With Mixed Features
This is a Phase 3, randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment, multicenter, inpatient study in participants with bipolar disorder experiencing an acute episode of mania or mania with mixed features. The primary objective of the study is to measure the how well it works of KarXT compared to dummy treatment (placebo) in treating symptoms of mania during a 3-week inpatient period.
Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are KarXT, or Placebo. The registry lists allocation as randomized. This is a Phase 3, randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment, multicenter, inpatient study in participants with bipolar disorder experiencing an acute episode of mania or mania with mixed features.
They plan to enroll about 274 people at 79 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
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)
Interventions: KarXT, Placebo
Primary outcome (registry wording): Change from baseline in Young Mania Rating Scale (YMRS) score
Who it is for (from inclusion criteria)
Ages 18 Years to 65 Years
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 the registry excludes
Participants must not have a primary diagnosis of BP-I with rapid cycling (≥ 4 distinct mood episodes in one year)
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 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 cirrhosis, liver cancer, clinically significant liver disease based on the liver function test results
Other protocol-defined Inclusion/
Public study contact (from the registry)
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
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The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT06951711?
Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT06951711?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.