This study wants to measure the how well it works and safety of added on top of your current treatment KarXT for the treatment of mania in participants with Bipolar-I Disorder.
Official registry: https://clinicaltrials.gov/study/NCT07140913 · Bristol-Myers Squibb · enrollment listed as 424
Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
If you join, the listed intervention(s) are Xanomeline/Trospium Chloride, or Placebo. The registry lists allocation as randomized. This study wants to measure the how well it works and safety of added on top of your current treatment KarXT for the treatment of mania in participants with Bipolar-I Disorder.
They plan to enroll about 424 people at 106 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
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 Taking Lithium, Valproate, or Lamotrigine
Interventions: Xanomeline/Trospium Chloride, Placebo
Primary outcome (registry wording): Change from baseline in Young Mania Rating Scale (YMRS) at Week 5
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
+ 84 sites outside the US on the same record
This study wants to use eye-tracking technology to study attentional biases, reward sensitivity, and cognitive control in adult patients with bipolar disorder with or without anxiety and/or substance use disorder comorbidity.
NCT03829787 · Official ClinicalTrials.gov record · University Hospitals Cleveland Medical Center
Background: More than 12,000 people have taken part in research at the Experimental Therapeutics \& Pathophysiology Branch at the National Institute of Mental Health Intramural Program. This has led to advances in the treatment of depression, bipolar disorder, and suicide risk.
NCT04877977 · Official ClinicalTrials.gov record · National Institute of Mental Health (NIMH)
Background: Mood disorders, such as bipolar disorder, can have serious effects on a person s life. People with bipolar disorder are more likely to have heart disease and abuse substances.
NCT05669703 · Official ClinicalTrials.gov record · National Institute of Mental Health (NIMH)
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary