A Study to Assess Adverse Events and Change in Disease Activity of Oral Icalcaprant in Adult Participants With Bipolar I or II Disorder
Recruiting · Phase 2 · NCT06696755
Conditions: Bipolar I Disorder, Bipolar II Disorder
At a glance
- Research payments reported, 2025
- $275,262
- U.S. investigators named
- 19
- Sites paid
- 17
- Planned or actual enrollment
- 195
About the trial
- Sponsor
- AbbVie
- Tested
- Icalcaprant (drug), Placebo for Icalcaprant (drug)
- Dates
- Started 2026-02-03; completion 2027-11
- Results posted
- Not yet
Bipolar disorder is a severe chronic mood disorder that affects up to 4% of the adult population and 1.8% of the pediatric population in the United States. This study will assess how safe and effective Icalcaprant is in treating adult participants with bipolar I or II disorder. Icalcaprant is an investigational drug being developed for the treatment of depressive episodes in adult participants with bipolar I or II disorder. Participants are placed in 1 of 3 groups, called treatment arms. There is a 1 in 3 chance that a participant will be assigned to a placebo. Around 195 adult participants with bipolar I or II disorder will be enrolled in approximately 35 sites across the United States o…
From ClinicalTrials.gov, last updated 2026-08-14. Full record, eligibility and contacts (opens in a new tab)
Industry funding
AbbVie Inc. reported $275,262 in research payments for this study in 2025 (279 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
- Richard Shelton Psychiatry · Birmingham, AL
- Haig A. Goenjian, MD Psychiatry · Long Beach, CA
- Steven Macina, DO Psychiatry · Huntington Beach, CA
- Martin I. Schuster, M.D Psychiatry · Sherman Oaks, CA
- Charmaine I. Semeniuk, M.D. Psychiatry · San Diego, CA
- Sherry Soefje, M.D. Psychiatry · Oceanside, CA
- Edwin A. Gomez, M.D. Psychiatry · Weston, FL
- Rosario B. Hidalgo, MD Psychiatry · Tampa, FL
- Morteza Nadjafi, M.D. Psychiatry · Orlando, FL
- Rosa E. Negron-munoz, MD Child & Adolescent Psychiatry · Lakeland, FL
- Elias H. Sarkis, MD Child & Adolescent Psychiatry · Gainesville, FL
- Sandeep N. Gaonkar, M.D. Psychiatry · Naperville, IL
- Roueen Rafeyan, M.D. Addiction Medicine · Chicago, IL
- Elia E. Acevedo Diaz, M.D Psychiatry · Gaithersburg, MD
- Veronique Sebastian, MD Psychiatry · Oklahoma City, OK
- Shivkumar S. Hatti, MD., MBA Psychiatry · Media, PA
- Scott R. Bartley, M.D. Psychiatry · Dallas, TX
- Prashant Gajwani, MD Psychiatry · Missouri City, TX
- Marshall B. Lucas, MD Psychiatry · The Woodlands, TX
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- $31,672
- Sandhill Research LLC $30,000
- Pillar Clinical Research LLC $24,064
- University of Alabama Hospital, AL $19,225
- Apg Research LLC $17,250
- Excell Research Inc $17,000
- Cbh Health LLC $15,032
- Research Centers of America LLC $15,032
- Clinicore International LLC $14,500
- The Ehs Medical Practice PA $14,032
- Erg Clinical Research California PC $13,532
- Schuster Medical Research Institute $13,300
- Advanced Research Center Inc $13,032
- Amr Conventions Research LTD $12,032
- Family Psychiatry of the Woodlands $11,027
- Sooner Clinical Research Inc $10,032
- Collaborative Neuroscience Research $3,500
- Suburban Research Assoc Inc $1,000
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.