jRCT2041250170
Recruiting
Not Applicable
A Phase 3, Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Individuals with Bipolar-I Disorder TakingLithium, Valproate, or Lamotrigine
Not provided0 sites27 target enrollmentStarted: TBD
ConditionsBipolar-I Disorder
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 27
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
Eligibility Criteria
- Ages
- 18age old over to 65age old under (—)
- Sex
- All
Inclusion Criteria
- •Participant must be 18 to 65 years of age, inclusive, at the time of signing the ICF.
- •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 with Borderline Personality Disorder
- •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.
- •Bodymass index >= 18 and =< 40 kg/m2
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 with Borderline PersonalityDisorderversion
- •at screening) including BP-Idepression, BP-Iwith rapid cycling, first manic episode, BP-II, borderline personality disorder, 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 with Borderline Personality Disorder version at screening), or current use as determined by urine toxicology screen or alcohol test.
- •Risk for suicidal behavior atscreening as determined by the investigator's clinical assessment and the C-SSRS with an answer "Yes" to item 4 or 5 within 6months before screeningor between screening and baseline, or suicide attempt within 12 months beforescreening, 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.
Investigators
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