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

Last updated: February 18, 2025
Sponsor: AbbVie
Overall Status: Active - Recruiting

Phase

2

Condition

N/A

Treatment

ABBV-932

Placebo for ABBV-932

Clinical Study ID

NCT06605599
M23-894
  • Ages 18-65
  • All Genders

Study 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

Inclusion Criteria:

  • Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, TextRevision (DSM-5-TR) criteria for bipolar I or II disorder without psychotic featuresbased on the Mini International Neuropsychiatric Interview (MINI), with a currentdepressive 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

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 enrolledin 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 5half-lives of the medication (whichever is longer).

  • Prior exposure to ABBV-932 within 90 days prior to baseline.

Study Design

Total Participants: 160
Treatment Group(s): 2
Primary Treatment: ABBV-932
Phase: 2
Study Start date:
October 15, 2024
Estimated Completion Date:
April 30, 2026

Connect with a study center

  • Kokura Mental Clinic /ID# 268031

    Kitakyushu, Fukuoka 802-0006
    Japan

    Active - Recruiting

  • Kawamura Mental Clinic /ID# 268325

    Sapporo, Hokkaido 001-0023
    Japan

    Active - Recruiting

  • Yutaka Clinic /ID# 268026

    Sagamihara, Kanagawa 252-0303
    Japan

    Active - Recruiting

  • Kaku Mental Clinic /ID# 268020

    Fukuoka, 810-0022
    Japan

    Active - Recruiting

  • Kuramitsu Hospital /ID# 268751

    Fukuoka, 819-0037
    Japan

    Active - Recruiting

  • BDH Research /ID# 267025

    San Juan, 00927
    Puerto Rico

    Active - Recruiting

  • INSPIRA Clinical Research /ID# 267041

    San Juan, 00918-3014
    Puerto Rico

    Active - Recruiting

  • Instituto De Neurologia Dra. Ivonne Fraga, Psc /ID# 267065

    San Juan, 00918
    Puerto Rico

    Active - Recruiting

  • Harmonex /ID# 267504

    Dothan, Alabama 36303
    United States

    Active - Recruiting

  • Advanced Research Center /ID# 267716

    Anaheim, California 92805
    United States

    Active - Recruiting

  • Axiom Research /ID# 267518

    Colton, California 92324
    United States

    Active - Recruiting

  • Collaborative Neuroscience Research - Garden Grove /ID# 267654

    Garden Grove, California 92845
    United States

    Active - Recruiting

  • Sun Valley Research Center /ID# 267708

    Imperial, California 92251
    United States

    Active - Recruiting

  • Alliance for Research Alliance for Wellness /ID# 267492

    Long Beach, California 90807
    United States

    Active - Recruiting

  • Excell Research /ID# 267541

    Oceanside, California 92056
    United States

    Active - Recruiting

  • Viking Clinical Research Center - Temecula /ID# 267634

    Temecula, California 92591
    United States

    Active - Recruiting

  • Accel Research Sites Network - St. Pete /ID# 267463

    Largo, Florida 33777
    United States

    Active - Recruiting

  • Allied Biomedical Res Inst Inc /ID# 267481

    Miami, Florida 33155
    United States

    Active - Recruiting

  • GMI Florida - Central Miami Medical Institute /ID# 267566

    Miami, Florida 33125-3724
    United States

    Active - Recruiting

  • K2 Medical Research - Orlando - South Orlando Avenue /ID# 267567

    Orlando, Florida 32751
    United States

    Active - Recruiting

  • Segal Trials - West Broward Outpatient Research Site /ID# 267947

    Tamarac, Florida 33319-4985
    United States

    Active - Recruiting

  • Benchmark Research /ID# 267626

    Shreveport, Louisiana 71101-4603
    United States

    Active - Recruiting

  • CenExel /ID# 267675

    Gaithersburg, Maryland 20877-1407
    United States

    Active - Recruiting

  • Arch Clinical Trials /ID# 267507

    Saint Louis, Missouri 63125
    United States

    Active - Recruiting

  • Oasis Clinical Research, LLC /ID# 267969

    Las Vegas, Nevada 89121
    United States

    Active - Recruiting

  • Center For Emotional Fitness - Cherry Hill /ID# 267661

    Cherry Hill, New Jersey 08002
    United States

    Active - Recruiting

  • Bio Behavioral Health /ID# 267493

    Toms River, New Jersey 08755
    United States

    Active - Recruiting

  • Neurobehavioral Research /ID# 267564

    Cedarhurst, New York 11516
    United States

    Active - Recruiting

  • New Hope Clinical Research - Inpatient unit /ID# 267465

    Charlotte, North Carolina 28211
    United States

    Active - Recruiting

  • Quest Therapeutics of Avon Lake /ID# 267558

    Avon Lake, Ohio 44012
    United States

    Active - Recruiting

  • OSU Psychiatry Department /ID# 267730

    Columbus, Ohio 43210
    United States

    Active - Recruiting

  • Sooner Clinical Research /ID# 267639

    Oklahoma City, Oklahoma 73116
    United States

    Active - Recruiting

  • Lehigh Center for Clinical Research /ID# 267451

    Allentown, Pennsylvania 18104
    United States

    Active - Recruiting

  • Suburban Research Associates - Media /ID# 267621

    Media, Pennsylvania 19063
    United States

    Active - Recruiting

  • Coastal Carolina Research Center, LLC /ID# 267550

    Charleston, South Carolina 29492
    United States

    Active - Recruiting

  • FutureSearch Trials of Dallas /ID# 267715

    Dallas, Texas 75231
    United States

    Active - Recruiting

  • Perceptive Pharma Research /ID# 267563

    Richmond, Texas 77407-3498
    United States

    Active - Recruiting

  • Grayline Research Center /ID# 267466

    Wichita Falls, Texas 76309
    United States

    Active - Recruiting

  • Northwest Clinical Research Center /ID# 267505

    Bellevue, Washington 98007
    United States

    Active - Recruiting

  • Core Clinical Research /ID# 268534

    Everett, Washington 98201
    United States

    Active - Recruiting

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