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Multicenter, Open-label Study to Evaluate the Long-term Safety and Tolerability of ABBV-932 in Subjects With Depressive Episodes Associated With Bipolar I or II Disorder
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.
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
No
Ima Clinical Research Phoenix (Alea) /ID# 278047
Phoenix, Arizona, United States
Advanced Research Center /ID# 273474
Anaheim, California, United States
Axiom Research /ID# 273482
Colton, California, United States
Collaborative Neuroscience Research - Garden Grove /ID# 273492
Garden Grove, California, United States
Sun Valley Research Center /ID# 273472
Imperial, California, United States
Synergy San Diego /ID# 278340
Lemon Grove, California, United States
Alliance for Research Alliance for Wellness /ID# 273477
Long Beach, California, United States
Nrc Research Institute - Los Angeles /ID# 278450
Los Angeles, California, United States
Excell Research /ID# 273483
Oceanside, California, United States
Inland Psychiatric Medical Group Inc. /ID# 273471
Temecula, California, United States
Start Date
September 30, 2025
Primary Completion Date
April 1, 2027
Completion Date
April 1, 2027
Last Updated
March 12, 2026
200
ESTIMATED participants
ABBV-932
DRUG
Lead Sponsor
AbbVie
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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