A Study to Assess Adverse Events and Change in Disease Activity of Oral Icalcaprant in Adult Participants With Bipolar I or II Disorder (NCT06696755)
A Phase 2, Multicenter, 6-Week, Double Blind, Placebo- Controlled Study to Evaluate the Efficacy and Safety of Icalcaprant in Subjects With Bipolar Depression
🩺 Plain-English Summary (8th-Grade Level)
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 of America. Participants will receive oral capsules of Icalcaprant or matching placebo once daily for 6 weeks, with a 4-week safety follow-up period. There may be a higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Who can join: Review the eligibility criteria below.
Location: University of Alabama - Huntsville Regional Medical Campus /ID# 272951 — Huntsville, Alabama
Age range: 18 Years to 65 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (33 Sites)
Showing the first 25 of 33 sites.
- University of Alabama - Huntsville Regional Medical Campus /ID# 272951 — Huntsville, Alabama
- Chandler Clinical Research Trials /ID# 274500 — Chandler, Arizona
- Del Sol Research Management - East Tanque Verde Road - Tucson /ID# 279767 — Tucson, Arizona
- Sanro Clinical Research Group /ID# 279462 — Bryant, Arkansas
- Advanced Research Center /ID# 272828 — Anaheim, California
- Collaborative Neuroscience Research - Garden Grove /ID# 271917 — Garden Grove, California
- Catalina Research Institute /ID# 272831 — Montclair, California
- Excell Research /ID# 272854 — Oceanside, California
- Pacific Neuropsychiatric Specialists - Orange /ID# 273118 — Orange, California
- Schuster Medical Research Institute /ID# 272848 — Sherman Oaks, California
- Sarkis Clinical Trials- Gainesville /ID# 272861 — Gainesville, Florida
- CenExel Hollywood FL /ID# 273101 — Hollywood, Florida
- Accel Research Sites Network - St. Pete /ID# 272962 — Largo, Florida
- Apg Research /ID# 272925 — Orlando, Florida
- Combined Research Orlando /ID# 279458 — Orlando, Florida
- Clinical Research Center Of Florida /ID# 278790 — Pompano Beach, Florida
- St. Johns Center for Clinical Research - Saint Augustine Location /ID# 279465 — Saint Augustine, Florida
- Neuroscience Institute - West Palm Beach /ID# 272922 — West Palm Beach, Florida
- Georgia Psychiatric Consultants and Advanced Discovery Research /ID# 279438 — Atlanta, Georgia
- Pillar Clinical Research - Chicago /ID# 272823 — Chicago, Illinois
- Amr Conventions Research /ID# 272867 — Warrenville, Illinois
- Saint Charles Psychiatric Associates /ID# 279239 — Saint Charles, Missouri
- Manhattan Behavioral Medicine /ID# 279769 — New York, New York
- University Of Cincinnati Medical Center /ID# 274160 — Cincinnati, Ohio
- The Ohio State University /ID# 272954 — Columbus, Ohio
📞 Contact the Study Coordinator
Phone: (844) 663-3742
Email: abbvieclinicaltrials@abbvie.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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- An Assessment of Efficacy, Safety, and Pharmacokinetics of NBI-1117568 in Adults With Bipolar I Disorder With Current Mania — Little Rock, Arkansas
- Individualized Pharmacological Approach to Obesity in Patients With Bipolar Disorder — Rochester, Minnesota
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Explore by condition: All Bipolar I Disorder clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.