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

Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
ABBV-932 Dose A 		Participants will receive ABBV-932 Dose A.
  • Drug: ABBV-932
    Oral Capsule
Experimental
ABBV-932 Dose B 		Participants will receive ABBV-932 Dose B.
  • Drug: ABBV-932
    Oral Capsule
Experimental
ABBV-932 Dose C 		Participants will receive ABBV-932 Dose C.
  • Drug: ABBV-932
    Oral Capsule
Placebo Comparator
Placebo for ABBV-932 		Participants will receive placebo.
  • Drug: Placebo for ABBV-932
    Oral Capsule

Recruiting Locations

Harmonex /ID# 267504
Dothan, Alabama 36303

Advanced Research Center /ID# 267716
Anaheim, California 92805

Axiom Research /ID# 267518
Colton, California 92324

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

Sun Valley Research Center /ID# 267708
Imperial, California 92251

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

Excell Research /ID# 267541
Oceanside, California 92056

Viking Clinical Research Center - Temecula /ID# 267634
Temecula, California 92591

Accel Research Sites Network - St. Pete /ID# 267463
Largo, Florida 33777

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

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

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

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

Benchmark Research /ID# 267626
Shreveport, Louisiana 71101-4603
Contact:
Site Coordinator
318-797-8988

CenExel /ID# 267675
Gaithersburg, Maryland 20877-1407

Arch Clinical Trials /ID# 267507
Saint Louis, Missouri 63125

Oasis Clinical Research, LLC /ID# 267969
Las Vegas, Nevada 89121

Center For Emotional Fitness - Cherry Hill /ID# 267661
Cherry Hill, New Jersey 08002

Bio Behavioral Health /ID# 267493
Toms River, New Jersey 08755

Neurobehavioral Research /ID# 267564
Cedarhurst, New York 11516

New Hope Clinical Research - Inpatient unit /ID# 267465
Charlotte, North Carolina 28211

Quest Therapeutics of Avon Lake /ID# 267558
Avon Lake, Ohio 44012

OSU Psychiatry Department /ID# 267730
Columbus, Ohio 43210

Sooner Clinical Research /ID# 267639
Oklahoma City, Oklahoma 73116

Lehigh Center for Clinical Research /ID# 267451
Allentown, Pennsylvania 18104

Suburban Research Associates - Media /ID# 267621
Media, Pennsylvania 19063

Coastal Carolina Research Center, LLC /ID# 267550
Charleston, South Carolina 29492

FutureSearch Trials of Dallas /ID# 267715
Dallas, Texas 75231

Perceptive Pharma Research /ID# 267563
Richmond, Texas 77407-3498

Grayline Research Center /ID# 267466
Wichita Falls, Texas 76309

Northwest Clinical Research Center /ID# 267505
Bellevue, Washington 98007

Core Clinical Research /ID# 268534
Everett, Washington 98201

INSPIRA Clinical Research /ID# 267041
San Juan, Puerto Rico 00918-3014

Instituto De Neurologia Dra. Ivonne Fraga, Psc /ID# 267065
San Juan, Puerto Rico 00918

BDH Research /ID# 267025
San Juan, Puerto Rico 00927

More Details

NCT ID
NCT06605599
Status
Recruiting
Sponsor
AbbVie

Study Contact

ABBVIE CALL CENTER
844-663-3742
abbvieclinicaltrials@abbvie.com

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center