Phase 3: testing KarXT for Bipolar-I Disorder With Mania or Mania With Mixed Features
This study wants to measure the how well it works and safety of KarXT for the treatment of manic episodes in Bipolar-I Disorder
Official registry: https://clinicaltrials.gov/study/NCT06951698 · Bristol-Myers Squibb · enrollment listed as 274
What this phase means
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 study wants to measure the how well it works and safety of KarXT for the treatment of manic episodes in Bipolar-I Disorder
They plan to enroll about 274 people at 74 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-1)
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 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 history or high risk of urinary retention, gastric retention, or untreated narrow-angle glaucoma
- Other protocol-defined Inclusion/
Public study contact (from the registry)
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
74 listed- Local Institution - 0058 — Bentonville, Arkansas (active_not_recruiting)
- Woodland International Research Group — Little Rock, Arkansas (recruiting)
- Advanced Research Center Inc. — Anaheim, California (recruiting)
- CITrials — Bellflower, California (recruiting)
- Local Institution - 0014 — Cerritos, California (not_yet_recruiting)
- Collaborative Neuroscience Research, LLC — Long Beach, California (recruiting)
- NRC Research Institute — Los Angeles, California (recruiting)
- Catalina Research Institute, LLC — Montclair, California (recruiting)
- Connecticut Mental Health Center — New Haven, Connecticut (recruiting)
- Research Centers of America ( Hollywood ) — Hollywood, Florida (recruiting)
- Advanced Research Institute of Miami — Homestead, Florida (recruiting)
- South Florida Research Phase I-IV — Miami, Florida (recruiting)
+ 51 sites outside the US on the same record
FAQ about this NCT record
Is NCT06951698 still recruiting?
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 NCT06951698?
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 NCT06951698?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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