COMPLETED

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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

Quick Facts

Study Start:2024-10-15
Study Completion:2025-12-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06605599

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.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * Have a minimum score of 20 on the 17-item Hamilton Depression Rating Scale (HAMD-17).
  3. * Have a minimum score of 2 on Item 1 of the HAMD-17 at screening.
  1. * Positive urine drug screen (UDS) result at screening.
  2. * 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.
  3. * 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).
  4. * Prior exposure to ABBV-932 within 90 days prior to baseline.

Contacts and Locations

Principal Investigator

ABBVIE INC.
STUDY_DIRECTOR
AbbVie

Study Locations (Sites)

Harmonex /ID# 267504
Dothan, Alabama, 36303
United States
Advanced Research Center /ID# 267716
Anaheim, California, 92805
United States
Axiom Research /ID# 267518
Colton, California, 92324
United States
Collaborative Neuroscience Research - Garden Grove /ID# 267654
Garden Grove, California, 92845
United States
Sun Valley Research Center /ID# 267708
Imperial, California, 92251
United States
Alliance for Research Alliance for Wellness /ID# 267492
Long Beach, California, 90807
United States
Excell Research /ID# 267541
Oceanside, California, 92056
United States
Viking Clinical Research Center - Temecula /ID# 267634
Temecula, California, 92591
United States
Accel Research Sites Network - St. Pete /ID# 267463
Largo, Florida, 33777
United States
GMI Florida - Central Miami Medical Institute /ID# 267566
Miami, Florida, 33125
United States
Allied Biomedical Res Inst Inc /ID# 267481
Miami, Florida, 33155
United States
K2 Medical Research - Orlando - South Orlando Avenue /ID# 267567
Orlando, Florida, 32751
United States
Segal Trials - West Broward Outpatient Research Site /ID# 267947
Tamarac, Florida, 33319-4985
United States
Benchmark Research /ID# 267626
Shreveport, Louisiana, 71101
United States
CenExel /ID# 267675
Gaithersburg, Maryland, 20877-1407
United States
Arch Clinical Trials /ID# 267507
St Louis, Missouri, 63125
United States
Duplicate_Oasis Clinical Research, LLC /ID# 267969
Las Vegas, Nevada, 89121
United States
Center For Emotional Fitness - Cherry Hill /ID# 267661
Cherry Hill, New Jersey, 08002
United States
Bio Behavioral Health /ID# 267493
Toms River, New Jersey, 08755
United States
Neurobehavioral Research /ID# 267564
Cedarhurst, New York, 11516
United States
New Hope Clinical Research - Inpatient unit /ID# 267465
Charlotte, North Carolina, 28211
United States
Quest Therapeutics of Avon Lake /ID# 267558
Avon Lake, Ohio, 44012
United States
OSU Psychiatry Department /ID# 267730
Columbus, Ohio, 43210
United States
Sooner Clinical Research /ID# 267639
Oklahoma City, Oklahoma, 73116
United States
Lehigh Center for Clinical Research /ID# 267451
Allentown, Pennsylvania, 18103
United States
Suburban Research Associates - Media /ID# 267621
Media, Pennsylvania, 19063
United States
Coastal Carolina Research Center, LLC /ID# 267550
Charleston, South Carolina, 29492
United States
FutureSearch Trials of Dallas /ID# 267715
Dallas, Texas, 75231
United States
Perceptive Pharma Research /ID# 267563
Richmond, Texas, 77407
United States
Grayline Research Center /ID# 267466
Wichita Falls, Texas, 76309
United States
Northwest Clinical Research Center /ID# 267505
Bellevue, Washington, 98007
United States
Core Clinical Research /ID# 268534
Everett, Washington, 98201
United States

Collaborators and Investigators

Sponsor: AbbVie

  • ABBVIE INC., STUDY_DIRECTOR, AbbVie

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-15
Study Completion Date2025-12-10

Study Record Updates

Study Start Date2024-10-15
Study Completion Date2025-12-10

Terms related to this study

Keywords Provided by Researchers

  • Bipolar I Disorder
  • Bipolar II Disorder
  • Bipolar Disorder
  • ABBV-932

Additional Relevant MeSH Terms

  • Bipolar I Disorder
  • Bipolar II Disorder