Study to Assess the Adverse Events of Oral ABBV-932 in Adult Participants With Depressive Episodes Associated With Bipolar I or II Disorder
NCT ID: NCT07220460
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
200 participants
INTERVENTIONAL
2025-09-30
2027-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
ABBV-932
Participants will receive oral ABBV-932 for a 26-week treatment period followed by a 30-day follow-up
ABBV-932
Oral Capsule
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ABBV-932
Oral Capsule
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Participants who currently meet the Diagnostic and Statistical Manual of Mental Disorders treatment (DSM-5-TR) criteria for bipolar I or II disorder without psychotic features based on the Mini International Neuropsychiatric Interview (MINI 7.0.2), currently experiencing a depressive episode of at least 4 weeks and not exceeding 12 months.
* Normal physical examination findings, clinical laboratory test results, vital signs, and 12-lead ECG results at screening or abnormal results that are judged not clinically significant by the investigator and documented as such in the eCRF
* Participant with the following psychiatric history:
* No history of psychiatric hospitalization (inpatient or intensive outpatient) in the past 3 months prior to screening.
* No lifetime history of schizophrenia, other psychotic disorders, dissociative disorders, or neurocognitive disorders.
* No history of moderate or severe substance use disorder (except nicotine) in the past 6 months prior to screening.
Exclusion Criteria
* History of an allergic reaction or significant sensitivity to constituents of the study drug (and its excipients) and/or other products in the same class.
* A concurrent medical condition that might interfere with the conduct of the study, confound the interpretation of the study results, or endanger the subject's well-being. This includes any unstable condition, history or evidence of malignancy (other than treated basal or squamous cell carcinoma), or any significant hematologic, endocrine, cardiovascular, respiratory, renal impairment or disease (subjects with eGFR \< 30 mL/min), hepatic (including history of severe hepatic impairment), gastrointestinal, or neurological disorder (if there is a history of such disease but the condition has been stable for more than 1 year, does not require treatment with prohibited medications, and is judged by the investigator not to interfere with participation in the study, the subject may be included in the study).
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AbbVie
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Alliance for Research Alliance for Wellness /ID# 273477
Long Beach, California, United States
Viking Clinical Research Center - Temecula /ID# 273471
Temecula, California, United States
Sunwise Clinical Research /ID# 278165
Walnut Creek, California, United States
Cns Healthcare - Jacksonville /ID# 278332
Jacksonville, Florida, United States
GMI Florida - Central Miami Medical Institute /ID# 273486
Miami, Florida, United States
Allied Biomedical Res Inst Inc /ID# 273476
Miami, Florida, United States
K2 Medical Research - Orlando - South Orlando Avenue /ID# 273487
Orlando, Florida, United States
Segal Trials - West Broward Outpatient Research Site /ID# 273496
Tamarac, Florida, United States
Arch Clinical Trials /ID# 273481
St Louis, Missouri, United States
Neurobehavioral Research /ID# 273470
Cedarhurst, New York, United States
Quest Therapeutics of Avon Lake /ID# 273484
Avon Lake, Ohio, United States
OSU Psychiatry Department /ID# 273495
Columbus, Ohio, United States
Sooner Clinical Research /ID# 273491
Oklahoma City, Oklahoma, United States
Perceptive Pharma Research /ID# 273485
Richmond, Texas, United States
Northwest Clinical Research Center /ID# 273480
Bellevue, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Related Links
Access external resources that provide additional context or updates about the study.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
M25-456
Identifier Type: -
Identifier Source: org_study_id