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A Phase 3 Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine
EU CTIS ID: 2025-521845-26-00
What this study is testing
- To determine the superiority of KarXT plus lithium, valproate, or lamotrigine compared with placebo (pill with no medicine) plus lithium, valproate, or lamotrigine in reducing the severity of acute mania, with or without mixed features, in participants with BP-I. - To determine if KarXT plus lithium, valproate or lamotrigine is better than placebo (“a dummy drug” with no medicine) plus lithium, valproate or lamotrigine 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) version 7.0.2 Standard with Borderline Personality Disorder version.
- 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.
You likely can't join if
- 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 Personality Disorder version at screening) including BP-I depression, BP-I with 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 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.
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) version 7.0.2 Standard with Borderline Personality Disorder version.
- 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
- 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 Personality Disorder version at screening) including BP-I depression, BP-I with 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 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]).
The study team makes the final eligibility decision.
Where it's taking place
- Japan
- Argentina
- Israel
- United States
- India
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 Japan; Argentina; Israel; United States; India. 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.