A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder
Recruiting · Phase 3 · NCT06951698
Conditions: Bipolar-I Disorder With Mania or Mania With Mixed Features
At a glance
- Research payments reported, 2025
- $76,463
- U.S. investigators named
- 18
- Sites paid
- 18
- Planned or actual enrollment
- 274
About the trial
- Sponsor
- Bristol-Myers Squibb
- Tested
- KarXT (drug), Placebo (other)
- Dates
- Started 2025-06-11; completion 2026-11-01
- Results posted
- Not yet
The purpose of this study is to evaluate the efficacy and safety of KarXT for the treatment of manic episodes in Bipolar-I Disorder
From ClinicalTrials.gov, last updated 2026-10-23. Full record, eligibility and contacts (opens in a new tab)
Industry funding
E.r. Squibb & Sons, L.l.c. reported $76,463 in research payments for this study in 2025 (18 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
- George Konis, M.D. Family Medicine · Little Rock, AR
- Robert G. Bota, MD Psychiatry · Costa Mesa, CA
- Steven Macina, DO Psychiatry · Huntington Beach, CA
- Morteza Marandi, M.D. Psychiatry · Cerritos, CA
- Stephen J. Volk, MD Psychiatry · Paramount, CA
- Deepak C. D'souza, M.D Psychiatry · West-haven, CT
- Edwin A. Gomez, M.D. Psychiatry · Weston, FL
- Rishi Kakar, M.D. Psychiatry · Tamarac, FL
- Mohammad Asim Nisar, MD Psychiatry · Okeechobee, FL
- Silvia I. Silva Duluc, M.D. Psychiatry · Miami, FL
- Moraima Trujillo, M.D. Psychiatry · Coral Gables, FL
- Bethany B. Davis, M.D. Psychiatry · Atlanta, GA
- Michael C. Mobley, M.D. Psychiatry · Savannah, GA
- Roueen Rafeyan, M.D. Addiction Medicine · Chicago, IL
- Peter Weiden, MD Psychiatry · Chicago, IL
- Shishuka Malhotra, M.D. Psychiatry · Canton, OH
- 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 $9,206
- Pillar Clinical Research, Llc $8,920
- Pillar Clinical Research Llc $6,669
- Advanced Research Institute of Miami $6,313
- Miami Lakes Medical Research $5,455
- Health Synergy Clinical Research $5,429
- South Florida Research Phase I To Iv, Inc $5,098
- Trialmed $4,499
- Research Centers of America $3,978
- Neuro Behavioral Clinical Research $3,690
- Citrials, Inc $3,109
- Richmond Behavioral Associates $2,429
- Advanced Research Center $2,419
- Synexus Clinical Research Limited $2,083
- Cenexel Iresearch, Llc $1,868
- Woodland International Research Group $1,865
- Connecticut Mental Health Center $1,776
- Catalina Research Institute, Llc $1,655
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.