A Study to Assess Adverse Events and Change in Disease Activity of Oral Icalcaprant in Adult Participants With Bipolar I or II Disorder

Summary

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.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

• Bipolar I Disorder
• Bipolar II Disorder

Eligibility basics and study details

Study type

Interventional

Phase

Phase 2

Ages

18 to 65 years

Sex

All

Healthy volunteers

Not accepted

Sponsor

AbbVie

Last updated on ClinicalTrials.gov

August 14, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites