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

NCT06605599 | Completed Phase 2 FDA Drug

• 1 other identifier: M23-894
• Study Type: interventional
• Target: 161
• Locations: 3 countries
• Sites: 40

Brief 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.

Conditions

Bipolar I Disorder; Bipolar II Disorder

Keywords

Bipolar I Disorder; Bipolar II Disorder; Bipolar Disorder; ABBV-932

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score

  The MADRS is a 10-item, clinician-rated scale that evaluates the participant's depressive symptomatology. Each item is scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity.

  Up to Week 6

Secondary Outcomes (3)

• Change From Baseline in Clinical Global Impression-Severity - Bipolar Disorder (CGI-S-BP)

  Up to Week 6

• Change From Baseline in Functioning Assessment Short Test (FAST) Total Score

  Up to Week 6

• Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score

  Up to Week 6

Study Arms (4)

ABBV-932 Dose A

EXPERIMENTAL

Participants will receive ABBV-932 Dose A.

Drug: ABBV-932

ABBV-932 Dose B

EXPERIMENTAL

Participants will receive ABBV-932 Dose B.

Drug: ABBV-932

ABBV-932 Dose C

EXPERIMENTAL

Participants will receive ABBV-932 Dose C.

Drug: ABBV-932

Placebo for ABBV-932

PLACEBO COMPARATOR

Participants will receive placebo.

Drug: Placebo for ABBV-932

Interventions

ABBV-932 DRUG

Oral Capsule

ABBV-932 Dose A; ABBV-932 Dose B; ABBV-932 Dose C

Placebo for ABBV-932 DRUG

Oral Capsule

Placebo for ABBV-932

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (40)

Harmonex /ID# 267504

Dothan, Alabama, 36303, United States

Location

Advanced Research Center /ID# 267716

Anaheim, California, 92805, United States

Location

Axiom Research /ID# 267518

Colton, California, 92324, United States

Location

Collaborative Neuroscience Research - Garden Grove /ID# 267654

Garden Grove, California, 92845, United States

Location

Sun Valley Research Center /ID# 267708

Imperial, California, 92251, United States

Location

Alliance for Research Alliance for Wellness /ID# 267492

Long Beach, California, 90807, United States

Location

Excell Research /ID# 267541

Oceanside, California, 92056, United States

Location

Viking Clinical Research Center - Temecula /ID# 267634

Temecula, California, 92591, United States

Location

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

Largo, Florida, 33777, United States

Location

GMI Florida - Central Miami Medical Institute /ID# 267566

Miami, Florida, 33125, United States

Location

Allied Biomedical Res Inst Inc /ID# 267481

Miami, Florida, 33155, United States

Location

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

Orlando, Florida, 32751, United States

Location

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

Tamarac, Florida, 33319-4985, United States

Location

Benchmark Research /ID# 267626

Shreveport, Louisiana, 71101, United States

Location

CenExel /ID# 267675

Gaithersburg, Maryland, 20877-1407, United States

Location

Arch Clinical Trials /ID# 267507

St Louis, Missouri, 63125, United States

Location

Duplicate_Oasis Clinical Research, LLC /ID# 267969

Las Vegas, Nevada, 89121, United States

Location

Center For Emotional Fitness - Cherry Hill /ID# 267661

Cherry Hill, New Jersey, 08002, United States

Location

Bio Behavioral Health /ID# 267493

Toms River, New Jersey, 08755, United States

Location

Neurobehavioral Research /ID# 267564

Cedarhurst, New York, 11516, United States

Location

New Hope Clinical Research - Inpatient unit /ID# 267465

Charlotte, North Carolina, 28211, United States

Location

Quest Therapeutics of Avon Lake /ID# 267558

Avon Lake, Ohio, 44012, United States

Location

OSU Psychiatry Department /ID# 267730

Columbus, Ohio, 43210, United States

Location

Sooner Clinical Research /ID# 267639

Oklahoma City, Oklahoma, 73116, United States

Location

Lehigh Center for Clinical Research /ID# 267451

Allentown, Pennsylvania, 18103, United States

Location

Suburban Research Associates - Media /ID# 267621

Media, Pennsylvania, 19063, United States

Location

Coastal Carolina Research Center, LLC /ID# 267550

Charleston, South Carolina, 29492, United States

Location

FutureSearch Trials of Dallas /ID# 267715

Dallas, Texas, 75231, United States

Location

Perceptive Pharma Research /ID# 267563

Richmond, Texas, 77407, United States

Location

Grayline Research Center /ID# 267466

Wichita Falls, Texas, 76309, United States

Location

Northwest Clinical Research Center /ID# 267505

Bellevue, Washington, 98007, United States

Location

Core Clinical Research /ID# 268534

Everett, Washington, 98201, United States

Location

Kokura Mental Clinic /ID# 268031

Kitakyushu, Fukuoka, 802-0006, Japan

Location

Kawamura Mental Clinic /ID# 268325

Sapporo, Hokkaido, 001-0023, Japan

Location

Yutaka Clinic /ID# 268026

Sagamihara, Kanagawa, 252-0303, Japan

Location

Kaku Mental Clinic /ID# 268020

Fukuoka, 810-0022, Japan

Location

Kuramitsu Hospital /ID# 268751

Fukuoka, 819-0037, Japan

Location

INSPIRA Clinical Research /ID# 267041

San Juan, 00918-3014, Puerto Rico

Location

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

San Juan, 00918, Puerto Rico

Location

BDH Research /ID# 267025

San Juan, 00927, Puerto Rico

Location

Related Links

• Related Info

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2024
• First Posted: September 20, 2024
• Study Start: October 15, 2024
• Primary Completion: November 12, 2025
• Study Completion: December 10, 2025
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
• Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

JP (5); US (32); PR (3)