Mania study: Xanomeline/Trospium Chloride
Official title 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
ClinicalTrials.gov ID: NCT07140913
What this study is testing
What is KarXT?
KarXT is an investigational oral medication being studied for the treatment of mania in people with Bipolar‑I Disorder.
Also referred to as Xanomeline/Trospium Chloride.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to see if adding KarXT helps control mania and to check its safety.
- Who it's for
- Adults with bipolar‑I disorder who are currently taking lithium, valproate, or lamotrigine and are experiencing mania.
- What's involved
- Participants will receive KarXT in addition to their current medication, attend scheduled clinic visits, and undergo routine safety and effectiveness tests.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Individuals have a primary diagnosis of Bipolar-I disorder established by a comprehensive psychiatric evaluation based on the DSM-5-TR criteria and...
- 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.
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 at screening) including BP-I...
- Individual has a DSM-5-TR diagnosis of moderate to severe substance use disorder (except tobacco use disorder) within the 12 months before screening...
- 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...
- 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...
See the full eligibility 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)...
- 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.
- YMRS Total Score of ≥ 18 at Screening and at Baseline, and \< 20% reduction in YMRS from screening to baseline.
- Any primary DSM-5-TR disorder other than BP-I within 12 months before screening (confirmed using MINI version 7.0.2 at screening) including BP-I depression (for previous 3 months only), BP-I with rapid cycling, first...
- 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...
- 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...
- 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 or 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Bentonville, Arkansas, United States
- Little Rock, Arkansas, United States
- Bellflower, California, United States
- Chino, California, United States
- Culver City, California, United States
- La Habra, California, United States
- Montclair, California, United States
- Orange, California, United States
- Riverside, California, United States
- Boynton Beach, Florida, United States
- Savannah, Georgia, United States
- Chicago, Illinois, United States
- St Louis, Missouri, United States
- Staten Island, New York, United States
- Austin, Texas, United States
- DeSoto, Texas, United States
- Houston, Texas, United States
- Mansfield, Texas, United States
- Richardson, Texas, United States
- Santiago del Estero, Argentina
+ 50 more site(s).
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, but 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 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Bentonville, Arkansas, United States; Little Rock, Arkansas, United States; Bellflower, California, United States; Chino, California, United States; Culver City, California, United States; La Habra, California, United States and 64 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.