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
← catalyst calendarNCT07140913 · readout in 313 d
Sponsored by Bristol-Myers Squibb (industry) · BMY — their whole pipeline →.
Phase
Phase 3
Status
Recruiting
Study type
Interventional
Design
Randomized · Double · Treatment
Enrollment
424estimated
Sites
104
Countries
Argentina, Bulgaria, China +10
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-10-08 | actual | When the study began enrolling |
| Primary completion | 2027-06-28 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-06-28 | estimated | The whole study's end, after follow-up |
| First posted | 2025-08-26 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-06-23 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Mania
- Bipolar Disorder
Interventions
- Drug: Xanomeline/Trospium Chloride — also filed as KarXT, BMS-986510
- Drug: Placebo
Primary outcome
what the primary-completion date above is the date OFChange from baseline in Young Mania Rating Scale (YMRS) at Week 5
measured At Week 5
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