Study of Oral ABBV-932 to Assess Adverse Events and Change in Disease Activity in Adult Participants With Bipolar I or II Disorder

Study Identifier
M23-894
CT.gov Identifier
NCT06605599
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Study Details

Medical Condition
  • Bipolar Disorder
    • Study Drug
  • ABBV-932
  • Placebo for ABBV-932
    • Phase
    Phase 2
    Sex
    Female & Male
    Age
    18 - 65 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * 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 Criteria:
    * 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.

    Protocol 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 participants 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. Study doctors put participants in 1 of 4 groups, called treatment arms. There is a 1 in 4 chance that a participant will be assigned to placebo. Around 160 adult participants with bipolar I or II disorder will be enrolled in approximately 40 sites worldwide.

    Participants will receive oral capsules of ABBV-932 or matching placebo once daily for 6 weeks. The treatment period will be followed by a safety follow-up (SFU) period for 4 weeks.

    There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular weekly 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.

    Study Locations

    Location
    Status
    Location
    Harmonex /ID# 267504
    Dothan, Alabama, United States, 36303
    Status
    Not applicable
    Location
    Advanced Research Center /ID# 267716
    Anaheim, California, United States, 92805
    Status
    Not applicable
    Location
    Axiom Research /ID# 267518
    Colton, California, United States, 92324
    Status
    Not applicable
    Location
    Collaborative Neuroscience Research - Garden Grove /ID# 267654
    Garden Grove, California, United States, 92845
    Status
    Not applicable
    Location
    Sun Valley Research Center /ID# 267708
    Imperial, California, United States, 92251
    Status
    Not applicable
    Location
    Alliance for Research Alliance for Wellness /ID# 267492
    Long Beach, California, United States, 90807
    Status
    Not applicable
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