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A Phase 3 Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder
EU CTIS ID: 2024-520165-32-00
What this study is testing
To determine if KarXT is better than placebo (“dummy drug” with no medicine) in reducing the severity and symptoms of mania in participants with BP-I.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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, v7.0.2).
- Individual is experiencing an acute episode or relapse of mania or mania with mixed features (≤ 3 weeks).
- The individual requires hospitalization for the acute exacerbation or relapse of mania.
- All psychotropic medications are washed out in no more than 14 days prior to the first dose of the study drug.
- Young Mania Rating Scale (YMRS) score of ≥ 20 at Screening and at Baseline.
You likely can't join if
- Any primary DSM-5-TR disorder, other than BP-I with mania or mania with mixed features within 12 months before screening (ie, primary focus of treatment, confirmed using MINI version 7.0.2 at screening), including BP-I with depression (for previous 3 months only), BP-II disorder, major depressive disorder, and primary psychotic disorder, with the exception of mild anxiety disorders.
- Primary diagnosis of BP-I with rapid cycling (≥ 4 distinct mood episodes in one year)
- 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 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” on items 4 or 5 (C-SSRS – ideation) within 6 months of screening, or "Yes” to any of 5 items (C-SSRS – behavior) within 12 months of screening or between screening and baseline.
- History of irritable bowel syndrome (with or without constipation) or serious constipation requiring treatment within the last 6 months.
- History or high risk of urinary retention, gastric retention, or untreated narrow-angle glaucoma.
See the full eligibility 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, v7.0.2).
- Individual is experiencing an acute episode or relapse of mania or mania with mixed features (≤ 3 weeks).
- The individual requires hospitalization for the acute exacerbation or relapse of mania.
- All psychotropic medications are washed out in no more than 14 days prior to the first dose of the study drug.
- Young Mania Rating Scale (YMRS) score of ≥ 20 at Screening and at Baseline.
- Clinical Global Impressions-Bipolar (CGI-BP) ≥ 4 at Screening and at Baseline.
- Any primary DSM-5-TR disorder, other than BP-I with mania or mania with mixed features within 12 months before screening (ie, primary focus of treatment, confirmed using MINI version 7.0.2 at screening), including BP-I with depression (for previous 3 months only), BP-II disorder, major depressive disorder, and primary psychotic disorder, with the exception of mild anxiety disorders.
- Primary diagnosis of BP-I with rapid cycling (≥ 4 distinct mood episodes in one year)
- 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 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” on items 4 or 5 (C-SSRS – ideation) within 6 months of screening, or "Yes” to any of 5 items (C-SSRS – behavior) within 12 months of screening or between screening and baseline.
- History of irritable bowel syndrome (with or without constipation) or serious constipation requiring treatment within the last 6 months.
- History or high risk of urinary retention, gastric retention, or untreated narrow-angle glaucoma.
The study team makes the final eligibility decision.
Where it's taking place
- New Zealand
- United States
- Australia
- Argentina
- Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Zealand; United States; Australia; Argentina; Japan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.