A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-2)
Recruiting · Phase 3 · NCT06951711
Conditions: Bipolar Disorder Type I With Mania or Mania With Mixed Features
At a glance
- Research payments reported, 2025
- $79,515
- U.S. investigators named
- 20
- Sites paid
- 21
- Planned or actual enrollment
- 274
About the trial
- Sponsor
- Bristol-Myers Squibb
- Tested
- KarXT (drug), Placebo (other)
- Dates
- Started 2025-06-13; completion 2026-11-02
- Results posted
- Not yet
This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, inpatient study in participants with bipolar disorder experiencing an acute episode of mania or mania with mixed features. The primary objective of the study is to evaluate the efficacy of KarXT compared to placebo in treating symptoms of mania during a 3-week inpatient period. The duration of the study including screening, the double-blind inpatient treatment period and safety-follow-up is no more than seven weeks.
From ClinicalTrials.gov, last updated 2026-10-20. Full record, eligibility and contacts (opens in a new tab)
Industry funding
E.r. Squibb & Sons, L.l.c. reported $79,515 in research payments for this study in 2025 (21 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
- Robert E. Billingsley JR., M. D. Psychiatry · Fayetteville, AR
- Leslie G. Smith, M.D. Psychiatry · Little Rock, AR
- Eric D. Adler, M.D Heart Failure & Transplant Cardiology · San Diego, CA
- Marina Bussel, M.D Psychiatry · Playa Vista, CA
- Evagelos Coskinas, M.D. Psychiatry · Costa Mesa, CA
- Lara G. Shirikjian, D.O. Psychiatry · Torrance, CA
- Rishi Kakar, M.D. Psychiatry · Tamarac, FL
- Yesenia Kuan, MD Psychiatry · Coral Gables, FL
- Olga Lapeyra, M.D. Psychiatry · Lauderhill, FL
- Mohammad Asim Nisar, MD Psychiatry · Okeechobee, FL
- Silvia I. Silva Duluc, M.D. Psychiatry · Miami, FL
- Kimball A. Johnson, MD Internal Medicine · Atlanta, GA
- Elia E. Acevedo Diaz, M.D Psychiatry · Gaithersburg, MD
- Junaid M. Syed, M.D. Psychiatry · Saint Louis, MO
- Kurian C. Abraham, MD Psychiatry · Charlotte, NC
- Elyssa L. Barron, M.D. Psychiatry · White Plains, NY
- Shishuka Malhotra, M.D. Psychiatry · Canton, OH
- Scott R. Bartley, M.D. Psychiatry · Dallas, TX
- Marsal Sanches, M.D. Psychiatry · Houston, TX
- Suresh Sureddi, M.D. Psychiatry · Plano, TX
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- South Florida Research Phase I To Iv, Inc $9,762
- Pillar Clinical Research- Little Rock $8,792
- Pillar Clinical Research, Llc $8,316
- Cenexel Atlanta $6,492
- Insite Clinical Research $6,158
- Proscience Research Group $6,051
- Cenexel Iresearch, Llc $4,032
- Collaborative Neuroscience Network, Llc $3,997
- Cbh Health, Llc $3,858
- Behavioral Clinical Research $3,395
- Arch Clinical Trials $2,841
- University of Cincinnati $2,807
- Woodland Research Northwest, Llc $1,718
- Health Synergy Clinical Research $1,618
- John S Dunn Behavioral Sciences Center at Uthealth Houston $1,449
- Clinical Innovations, Incorporated $1,393
- Miami Lakes Medical Research $1,390
- Lcc Medical Research Institute $1,382
- Precise Research Center $1,357
- New Hope Clinical Research-Tammy Rader $1,356
- Neuro Behavioral Clinical Research $1,352
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.