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
Recruiting · Phase 3 · NCT07140913
Conditions: Mania, Bipolar Disorder
At a glance
- Research payments reported, 2025
- $13,009
- U.S. investigators named
- 5
- Sites paid
- 5
- Planned or actual enrollment
- 424
About the trial
- Sponsor
- Bristol-Myers Squibb
- Tested
- Xanomeline/Trospium Chloride (drug), Placebo (drug)
- Dates
- Started 2025-10-08; completion 2027-06-28
- Results posted
- Not yet
The purpose of this study is to evaluate the efficacy and safety of adjunctive KarXT for the treatment of mania in participants with Bipolar-I Disorder.
From ClinicalTrials.gov, last updated 2026-11-03. Full record, eligibility and contacts (opens in a new tab)
Industry funding
E.r. Squibb & Sons, L.l.c. reported $13,009 in research payments for this study in 2025 (5 payments).
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- Fayz A. Hudefi, MD Addiction Medicine · Fort Smith, AR
- Leslie G. Smith, M.D. Psychiatry · Little Rock, AR
- Mohammad Asim Nisar, MD Psychiatry · Okeechobee, FL
- Roueen Rafeyan, M.D. Addiction Medicine · Chicago, IL
- Scott R. Bartley, M.D. Psychiatry · Dallas, TX
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Pillar Clinical Research, Llc $3,204
- Health Synergy Clinical Research $2,951
- Pillar Clinical Research $2,740
- Pillar Clinical Research- Little Rock $2,155
- Pillar Clinical Research Llc $1,959
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.