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Study of Oral ABBV-932 to Assess Adverse Events and Change in Disease Activity in Adult Participants With Bipolar I or II Disorder
Sponsor: AbbVie
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
161
Start Date
2024-10-15
Completion Date
2025-12-10
Last Updated
2026-10-14
Healthy Volunteers
No
Conditions
Interventions
ABBV-932
Oral Capsule
Placebo for ABBV-932
Oral Capsule
Locations (40)
Harmonex /ID# 267504
Dothan, Alabama, United States
Advanced Research Center /ID# 267716
Anaheim, California, United States
Axiom Research /ID# 267518
Colton, California, United States
Collaborative Neuroscience Research - Garden Grove /ID# 267654
Garden Grove, California, United States
Sun Valley Research Center /ID# 267708
Imperial, California, United States
Alliance for Research Alliance for Wellness /ID# 267492
Long Beach, California, United States
Excell Research /ID# 267541
Oceanside, California, United States
Viking Clinical Research Center - Temecula /ID# 267634
Temecula, California, United States
Accel Research Sites Network - St. Pete /ID# 267463
Largo, Florida, United States
GMI Florida - Central Miami Medical Institute /ID# 267566
Miami, Florida, United States
Allied Biomedical Res Inst Inc /ID# 267481
Miami, Florida, United States
K2 Medical Research - Orlando - South Orlando Avenue /ID# 267567
Orlando, Florida, United States
Segal Trials - West Broward Outpatient Research Site /ID# 267947
Tamarac, Florida, United States
Benchmark Research /ID# 267626
Shreveport, Louisiana, United States
CenExel /ID# 267675
Gaithersburg, Maryland, United States
Arch Clinical Trials /ID# 267507
St Louis, Missouri, United States
Duplicate_Oasis Clinical Research, LLC /ID# 267969
Las Vegas, Nevada, United States
Center For Emotional Fitness - Cherry Hill /ID# 267661
Cherry Hill, New Jersey, United States
Bio Behavioral Health /ID# 267493
Toms River, New Jersey, United States
Neurobehavioral Research /ID# 267564
Cedarhurst, New York, United States
New Hope Clinical Research - Inpatient unit /ID# 267465
Charlotte, North Carolina, United States
Quest Therapeutics of Avon Lake /ID# 267558
Avon Lake, Ohio, United States
OSU Psychiatry Department /ID# 267730
Columbus, Ohio, United States
Sooner Clinical Research /ID# 267639
Oklahoma City, Oklahoma, United States
Lehigh Center for Clinical Research /ID# 267451
Allentown, Pennsylvania, United States
Suburban Research Associates - Media /ID# 267621
Media, Pennsylvania, United States
Coastal Carolina Research Center, LLC /ID# 267550
Charleston, South Carolina, United States
FutureSearch Trials of Dallas /ID# 267715
Dallas, Texas, United States
Perceptive Pharma Research /ID# 267563
Richmond, Texas, United States
Grayline Research Center /ID# 267466
Wichita Falls, Texas, United States
Northwest Clinical Research Center /ID# 267505
Bellevue, Washington, United States
Core Clinical Research /ID# 268534
Everett, Washington, United States
Kaku Mental Clinic /ID# 268020
Fukuoka, Fukuoka, Japan
Kuramitsu Hospital /ID# 268751
Fukuoka, Fukuoka, Japan
Kokura Mental Clinic /ID# 268031
Kitakyushu, Fukuoka, Japan
Kawamura Mental Clinic /ID# 268325
Sapporo, Hokkaido, Japan
Yutaka Clinic /ID# 268026
Sagamihara, Kanagawa, Japan
INSPIRA Clinical Research /ID# 267041
San Juan, Puerto Rico, Puerto Rico
Instituto De Neurologia Dra. Ivonne Fraga, Psc /ID# 267065
San Juan, Puerto Rico, Puerto Rico
BDH Research /ID# 267025
San Juan, Puerto Rico, Puerto Rico