Open-Label Phase 2 Study of Oral ABBV-932 for Safety in Adults With Depressive Episodes of Bipolar I or II Disorder

What this Trial Is About

Bipolar disorder is a serious long-term mood condition affecting up to 4% of adults in the United States. This research evaluates the safety and effects of ABBV-932, an investigational drug, in adults experiencing depressive episodes related to bipolar I or II disorder. The study aims to understand how well ABBV-932 works and its safety profile for this specific group. Participants will take oral ABBV-932 capsules for 26 weeks during the treatment phase. After this, there will be a 30-day safety follow-up period to monitor any ongoing effects or side effects. The study is open-label, so all participants receive ABBV-932, and no placebo group is involved. During the study, participants will attend regular visits at hospitals or clinics where medical assessments, blood tests, side effect checks, and questionnaires will be completed. Researchers will track various safety measures including vital signs, ECG changes, lab tests, and symptom scales related to movement, sleepiness, mood, and suicidal thoughts. The total participation time includes the treatment period plus the follow-up, lasting approximately 27 weeks.

Study to Assess the Adverse Events of Oral ABBV-932 in Adult Participants With Depressive Episodes Associated With Bipolar I or II Disorder