Bipolar disorder is a severe chronic mood disorder that affects up to 4% of the adult population in the United States. The purpose of this study is to assess how safe and effective ABBV-932 is in treating participants with depressive episodes associated with bipolar I or II disorder. ABBV-932 is an investigational drug being developed for the treatment of depressive episodes in adult participants with bipolar I or II disorder. Participants with bipolar I or II disorder who are currently experiencing a depressive episode will enter the study and be treated with open-label ABBV-932. Approximately 200 adult participants with bipolar I or II disorder will be enrolled in approximately 50 sites in the United States and Puerto Rico. Participants will receive oral capsules of ABBV-932 for a 26-week treatment period. The treatment period will be followed by a safety follow-up (SFU) period of 30 days. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regularly scheduled 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.
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Number of Participants Experiencing Adverse Events
Timeframe: Up to approximately 29 weeks
Number of Participants with Abnormal Change From Baseline in Vital Sign Measurements
Timeframe: Up to week 26
Number of Participants with Change from Baseline in Electrocardiogram (ECG)
Timeframe: Up to week 26
Number of Participants with Abnormal Change in Clinical Laboratory Test Results Like Hematology will be Assessed
Timeframe: Up to week 26
Change From Baseline in Simpson-Angus Scale (SAS)
Timeframe: Up to week 26
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS)
Timeframe: Up to week 26
Change From Baseline in Barnes Akathisia Rating Scale (BARS)
Timeframe: Up to week 26
Change from Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS)
Timeframe: Up to week 26
Change From Baseline in the Epworth Sleepiness Scale (ESS)
Timeframe: Up to week 26
Change From Baseline in the Young Mania Rating Scale (YMRS)
Timeframe: Up to week 26
Number of Participants with Abnormal Change in Ocular Examination
Timeframe: Up to week 26