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Completed
NCT06605599
Study of Oral ABBV-932 to Assess Adverse Events and Change in Disease Activity in Adult Participants With Bipolar I or II Disorder
Conditions: Bipolar I Disorder, Bipolar II Disorder
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 161
Sponsor: AbbVie
Location: Harmonex /ID# 267504 Dothan Alabama
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.
Eligibility 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.
Source: ClinicalTrials.gov (NCT06605599). StuddyBuddy aggregates publicly available trial information.