Condition: Bipolar I Disorder · Bipolar II Disorder · Sponsor: AbbVie
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.
This description comes directly from the study's public registry record.
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Always discuss trial participation with your own doctor first.
| University of Alabama - Huntsville Regional Medical Campus /ID# 272951 | Huntsville, Alabama, United States | Recruiting |
| Chandler Clinical Research Trials /ID# 274500 | Chandler, Arizona, United States | Recruiting |
| Del Sol Research Management - East Tanque Verde Road - Tucson /ID# 279767 | Tucson, Arizona, United States | Recruiting |
| Sanro Clinical Research Group /ID# 279462 | Bryant, Arkansas, United States | Recruiting |
| Advanced Research Center /ID# 272828 | Anaheim, California, United States | Recruiting |
| Collaborative Neuroscience Research - Garden Grove /ID# 271917 | Garden Grove, California, United States | Recruiting |
| Catalina Research Institute /ID# 272831 | Montclair, California, United States | Recruiting |
| Excell Research /ID# 272854 | Oceanside, California, United States | Recruiting |
| Pacific Neuropsychiatric Specialists - Orange /ID# 273118 | Orange, California, United States | Recruiting |
| Schuster Medical Research Institute /ID# 272848 | Sherman Oaks, California, United States | Recruiting |
| Sarkis Clinical Trials- Gainesville /ID# 272861 | Gainesville, Florida, United States | Recruiting |
| CenExel Hollywood FL /ID# 273101 | Hollywood, Florida, United States | Recruiting |
+ 21 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06696755