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

Description

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.

Conditions

Bipolar I Disorder, Bipolar II Disorder

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Study Overview

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Study Details

Study overview

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.

Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Fixed-dose Study to Evaluate the Efficacy, Safety, and Tolerability of ABBV-932 in Subjects With Depressive Episodes Associated With Bipolar I or II Disorder

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

Condition
Bipolar I Disorder
Intervention / Treatment

-

Contacts and Locations

Dothan

Harmonex /ID# 267504, Dothan, Alabama, United States, 36303

Colton

Axiom Research /ID# 267518, Colton, California, United States, 92324

Garden Grove

Collaborative Neuroscience Research - Garden Grove /ID# 267654, Garden Grove, California, United States, 92845

Long Beach

Alliance for Research Alliance for Wellness /ID# 267492, Long Beach, California, United States, 90807

Oceanside

Excell Research /ID# 267541, Oceanside, California, United States, 92056

Miami

GMI Florida - Central Miami Medical Institute /ID# 267566, Miami, Florida, United States, 33125-3724

Miami

Allied Biomedical Res Inst Inc /ID# 267481, Miami, Florida, United States, 33155

Orlando

K2 Medical Research - Orlando - South Orlando Avenue /ID# 267567, Orlando, Florida, United States, 32751

Tamarac

Segal Trials - West Broward Outpatient Research Site /ID# 267947, Tamarac, Florida, United States, 33319-4985

Shreveport

Benchmark Research /ID# 267626, Shreveport, Louisiana, United States, 71101-4603

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

AbbVie,

ABBVIE INC., STUDY_DIRECTOR, AbbVie

Study Record Dates

2026-04