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
Status: Recruiting
Location: See all (40) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• 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.
Locations
United States
Alabama
Harmonex /ID# 267504
RECRUITING
Dothan
California
Advanced Research Center /ID# 267716
RECRUITING
Anaheim
Axiom Research /ID# 267518
RECRUITING
Colton
Collaborative Neuroscience Research - Garden Grove /ID# 267654
RECRUITING
Garden Grove
Sun Valley Research Center /ID# 267708
RECRUITING
Imperial
Alliance for Research Alliance for Wellness /ID# 267492
RECRUITING
Long Beach
Excell Research /ID# 267541
RECRUITING
Oceanside
Viking Clinical Research Center - Temecula /ID# 267634
RECRUITING
Temecula
Florida
Accel Research Sites Network - St. Pete /ID# 267463
RECRUITING
Largo
Allied Biomedical Res Inst Inc /ID# 267481
RECRUITING
Miami
GMI Florida - Central Miami Medical Institute /ID# 267566
RECRUITING
Miami
K2 Medical Research - Orlando - South Orlando Avenue /ID# 267567
RECRUITING
Orlando
Segal Trials - West Broward Outpatient Research Site /ID# 267947
RECRUITING
Tamarac
Louisiana
Benchmark Research /ID# 267626
RECRUITING
Shreveport
Maryland
CenExel /ID# 267675
RECRUITING
Gaithersburg
Missouri
Arch Clinical Trials /ID# 267507
RECRUITING
St Louis
North Carolina
New Hope Clinical Research - Inpatient unit /ID# 267465
RECRUITING
Charlotte
New Jersey
Center For Emotional Fitness - Cherry Hill /ID# 267661
RECRUITING
Cherry Hill
Bio Behavioral Health /ID# 267493
RECRUITING
Toms River
Nevada
Oasis Clinical Research, LLC /ID# 267969
COMPLETED
Las Vegas
New York
Neurobehavioral Research /ID# 267564
RECRUITING
Cedarhurst
Ohio
Quest Therapeutics of Avon Lake /ID# 267558
RECRUITING
Avon Lake
OSU Psychiatry Department /ID# 267730
RECRUITING
Columbus
Oklahoma
Sooner Clinical Research /ID# 267639
RECRUITING
Oklahoma City
Pennsylvania
Lehigh Center for Clinical Research /ID# 267451
RECRUITING
Allentown
Suburban Research Associates - Media /ID# 267621
RECRUITING
Media
South Carolina
Coastal Carolina Research Center, LLC /ID# 267550
RECRUITING
Charleston
Texas
FutureSearch Trials of Dallas /ID# 267715
RECRUITING
Dallas
Perceptive Pharma Research /ID# 267563
RECRUITING
Richmond
Grayline Research Center /ID# 267466
RECRUITING
Wichita Falls
Washington
Northwest Clinical Research Center /ID# 267505
RECRUITING
Bellevue
Core Clinical Research /ID# 268534
RECRUITING
Everett
Other Locations
Japan
Kaku Mental Clinic /ID# 268020
RECRUITING
Fukuoka
Kuramitsu Hospital /ID# 268751
RECRUITING
Fukuoka
Kokura Mental Clinic /ID# 268031
RECRUITING
Kitakyushu
Yutaka Clinic /ID# 268026
RECRUITING
Sagamihara
Kawamura Mental Clinic /ID# 268325
RECRUITING
Sapporo
Puerto Rico
BDH Research /ID# 267025
RECRUITING
San Juan
INSPIRA Clinical Research /ID# 267041
RECRUITING
San Juan
Instituto De Neurologia Dra. Ivonne Fraga, Psc /ID# 267065