Status:
ACTIVE_NOT_RECRUITING
Study of Oral ABBV-932 to Assess Adverse Events and Change in Disease Activity in Adult Participants With Bipolar I or II Disorder
Lead Sponsor:
AbbVie
Conditions:
Bipolar I Disorder
Bipolar 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. This study will assess how safe and effective ABBV-932 is in treating participant...
Eligibility Criteria
Inclusion
- Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria for bipolar I or II disorder without psychotic features based on the Mini International Neuropsychiatric Interview (MINI), with a current depressive episode of at least 4 weeks and not exceeding 12 months.
- Have a minimum score of 20 on the 17-item Hamilton Depression Rating Scale (HAMD-17).
- Have a minimum score of 2 on Item 1 of the HAMD-17 at screening.
Exclusion
- Positive urine drug screen (UDS) result at screening.
- Treated with any investigational drug within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to the first dose of study drug, is currently enrolled in another clinical study, or was previously enrolled in this study.
- Current use of any antipsychotic, antidepressant, anticonvulsant, mood stabilizer, herb, or over-the-counter medication with psychoactive potential within 1 week or 5 half-lives of the medication (whichever is longer).
- Prior exposure to ABBV-932 within 90 days prior to baseline.
Key Trial Info
Start Date :
October 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT06605599
Start Date
October 15 2024
End Date
December 1 2025
Last Update
December 17 2025
Active Locations (40)
Enter a location and click search to find clinical trials sorted by distance.
1
Harmonex /ID# 267504
Dothan, Alabama, United States, 36303
2
Advanced Research Center /ID# 267716
Anaheim, California, United States, 92805
3
Axiom Research /ID# 267518
Colton, California, United States, 92324
4
Collaborative Neuroscience Research - Garden Grove /ID# 267654
Garden Grove, California, United States, 92845