A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine
Not Applicable
Not yet recruiting
- Conditions
- ManiaBipolar Disorder
- Interventions
- Registration Number
- NCT07140913
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to evaluate the efficacy and safety of adjunctive KarXT for the treatment of mania in participants with Bipolar-I Disorder.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 424
Inclusion Criteria
- Individuals have a primary diagnosis of Bipolar-I disorder established by a comprehensive psychiatric evaluation based on the DSM-5-TR criteria and confirmed by the Mini International Neuropsychiatric Interview (MINI) version 7.0.2 Standard.
- Individual is experiencing an acute exacerbation or relapse of manic episode, with or without mixed features (≤ 3 weeks).
- The individual requires hospitalization for the acute exacerbation or relapse of mania.
- Body mass index ≥ 18 and ≤ 40 kg/m2
- Currently experiencing an acute episode of mania or mania with mixed features with a therapeutic dose of lithium, valproate, or lamotrigine. The dose of the mood stabilizer must have remained stable for at least two weeks prior to screening. Additionally, participants on valproate must have been receiving treatment with valproate for a minimum of seven months.
- YMRS Total Score of ≥ 18 at Screening and at Baseline, and < 20% reduction in YMRS from screening to baseline.
- Clinical Global Impression Severity scale (CGI-BP) ≥ 4
Exclusion Criteria
- Any primary DSM-5-TR disorder other than BP-I within 12 months before screening (confirmed using MINI version 7.0.2 Standard) including BP-I depression, BP-I with rapid cycling, first manic episode, BP-II, and major depressive disorder.
- Individual has a DSM-5-TR diagnosis of moderate to severe substance use disorder (except tobacco use disorder) within the 12 months before screening (confirmed using MINI version 7.0.2 Standard at screening), or current use as determined by urine toxicology screen or alcohol test.
- Risk for suicidal behavior at screening as determined by the investigator's clinical assessment and the C-SSRS with an answer "Yes" to item 4 or 5 within 6 months before screening or between screening and baseline, or suicide attempt within 12 months before screening, or between screening and baseline
- History of irritable bowel syndrome (with or without constipation) or any serious constipation requiring treatment within the last 6 months.
- History or high risk of urinary retention, gastric retention, or narrow-angle glaucoma.
- Participants with HIV, cirrhosis, biliary duct abnormalities, hepatobiliary carcinoma, and/or active hepatic viral infections based on either medical history or the LFT results.
- Elevations in hepatic transaminases at screening ≥ 2 × ULN for ALT and AST and/or bilirubin > 1.5× ULN, unless in the context of Gilbert's syndrome.
- All grades of hepatic impairment (mild [Child-Pugh Class A], moderate [Child-Pugh Class B], and severe [Child-Pugh Class C]).
- Other protocol-defined Inclusion/Exclusion criteria apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description KarXT + Lithium, Valproate, or Lamotrigine Xanomeline/Trospium Chloride - KarXT + Lithium, Valproate, or Lamotrigine Lithium - KarXT + Lithium, Valproate, or Lamotrigine Valproate - KarXT + Lithium, Valproate, or Lamotrigine Lamotrigine - Placebo + Lithium, Valproate, or Lamotrigine Lithium - Placebo + Lithium, Valproate, or Lamotrigine Valproate - Placebo + Lithium, Valproate, or Lamotrigine Lamotrigine - Placebo + Lithium, Valproate, or Lamotrigine Placebo -
- Primary Outcome Measures
Name Time Method Change from baseline in Young Mania Rating Scale (YMRS) at Week 5 At Week 5
- Secondary Outcome Measures
Name Time Method Change from baseline in Clinical Global Impressions Bipolar (CGI-BP) at Week 5 At Week 5 Occurrence of response at Week 5 assessed as the number of participants with a ≥ 50% decrease from baseline in Young Mania Rating Scale (YMRS) score At Week 5 Occurrence of response at Week 5 assessed as the number of participants with a ≥ 1 change from baseline in CGI-BP At Week 5 Number of participants with Treatment-emergent Adverse Events (TEAEs) Up to Week 7 Number of participants with Serious Adverse Events (SAEs) Up to Week 7 Number of participants with TEAEs leading to treatment discontinuation Up to Week 5 Change from baseline in Columbia-Suicide Severity Rating Scale (C-SSRS) Up to Week 7 Change from baseline in Barnes Akathisia Rating Scale (BARS) at Week 5 At Week 5 Change from baseline in Simpson Angus Scale (SAS) at Week 5 At Week 5 Change from baseline in Abnormal Involuntary Movement Scale (AIMS) at Week 5 At Week 5 Change from baseline in International Prostate Symptom Score (IPSS) at Week 5 At Week 5
Trial Locations
- Locations (32)
Local Institution - 0029
🇺🇸Bentonville, Arkansas, United States
Local Institution - 0018
🇺🇸Little Rock, Arkansas, United States
Local Institution - 0049
🇺🇸Chino, California, United States
Local Institution - 0015
🇺🇸Hallandale, Florida, United States
Local Institution - 0021
🇺🇸Miami Springs, Florida, United States
Local Institution - 0016
🇺🇸Stuart, Florida, United States
Local Institution - 0017
🇺🇸Chicago, Illinois, United States
Local Institution - 0026
🇺🇸Austin, Texas, United States
Local Institution - 0033
🇺🇸Richardson, Texas, United States
Local Institution - 0054
🇩🇰Aalborg, North Denmark, Denmark
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