Status:
RECRUITING
Study to Assess the Adverse Events of Oral ABBV-932 in Adult Participants With Depressive Episodes Associated With Bipolar I or II Disorder
Lead Sponsor:
AbbVie
Conditions:
Bipolar I or II Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
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 trea...
Eligibility Criteria
Inclusion
- Body Mass Index (BMI) ≥ 18.0 to ≤ 40.0 kg/m\^2, inclusive.
- 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
- A total score greater than 12 on the Young Mania Rating Scale (YMRS) at baseline.
- 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).
Key Trial Info
Start Date :
September 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT07220460
Start Date
September 30 2025
End Date
April 1 2027
Last Update
January 2 2026
Active Locations (34)
Enter a location and click search to find clinical trials sorted by distance.
1
Ima Clinical Research Phoenix (Alea) /ID# 278047
Phoenix, Arizona, United States, 85012
2
Advanced Research Center /ID# 273474
Anaheim, California, United States, 92805
3
Axiom Research /ID# 273482
Colton, California, United States, 92324
4
Collaborative Neuroscience Research - Garden Grove /ID# 273492
Garden Grove, California, United States, 92845