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RECRUITING

NCT07220460

PHASE2

Study to Assess the Adverse Events of Oral ABBV-932 in Adult Participants With Depressive Episodes Associated With Bipolar I or II Disorder

Sponsor: AbbVie

View on ClinicalTrials.gov

Summary

Bipolar disorder is a severe chronic mood disorder that affects up to 4% of the adult population in the United States. The purpose of this study is to assess how safe and effective ABBV-932 is in treating participants with depressive episodes associated 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. Participants with bipolar I or II disorder who are currently experiencing a depressive episode will enter the study and be treated with open-label ABBV-932. Approximately 200 adult participants with bipolar I or II disorder will be enrolled in approximately 50 sites in the United States and Puerto Rico. Participants will receive oral capsules of ABBV-932 for a 26-week treatment period. The treatment period will be followed by a safety follow-up (SFU) period of 30 days. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regularly scheduled 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, Open-label Study to Evaluate the Long-term 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

200

Start Date

2025-09-30

Completion Date

2027-04

Last Updated

2026-04-07

Healthy Volunteers

Conditions

Bipolar I or II Disorder

Interventions

DRUG

ABBV-932

Oral Capsule

Inclusion Criteria: * Body Mass Index (BMI) ≥ 18.0 to ≤ 40.0 kg/m\^2, inclusive. * Participants who currently meet the Diagnostic and Statistical Manual of Mental Disorders treatment (DSM-5-TR) criteria for bipolar I or II disorder without psychotic features based on the Mini International Neuropsychiatric Interview (MINI 7.0.2), currently experiencing a depressive episode of at least 4 weeks and not exceeding 12 months. * Normal physical examination findings, clinical laboratory test results, vital signs, and 12-lead ECG results at screening or abnormal results that are judged not clinically significant by the investigator and documented as such in the eCRF * Participant with the following psychiatric history: * No history of psychiatric hospitalization (inpatient or intensive outpatient) in the past 3 months prior to screening. * No lifetime history of schizophrenia, other psychotic disorders, dissociative disorders, or neurocognitive disorders. * No history of moderate or severe substance use disorder (except nicotine) in the past 6 months prior to screening. Exclusion Criteria: * A total score greater than 12 on the Young Mania Rating Scale (YMRS) at baseline. * History of an allergic reaction or significant sensitivity to constituents of the study drug (and its excipients) and/or other products in the same class. * A concurrent medical condition that might interfere with the conduct of the study, confound the interpretation of the study results, or endanger the subject's well-being. This includes any unstable condition, history or evidence of malignancy (other than treated basal or squamous cell carcinoma), or any significant hematologic, endocrine, cardiovascular, respiratory, renal impairment or disease (subjects with eGFR \< 30 mL/min), hepatic (including history of severe hepatic impairment), gastrointestinal, or neurological disorder (if there is a history of such disease but the condition has been stable for more than 1 year, does not require treatment with prohibited medications, and is judged by the investigator not to interfere with participation in the study, the subject may be included in the study).

Locations (49)

Ima Clinical Research Phoenix (Alea) /ID# 278047

Phoenix, Arizona, United States

Advanced Research Center /ID# 273474

Anaheim, California, United States

Axiom Research /ID# 273482

Colton, California, United States

Collaborative Neuroscience Research - Garden Grove /ID# 273492

Garden Grove, California, United States

Sun Valley Research Center /ID# 273472

Imperial, California, United States

Synergy San Diego /ID# 278340

Lemon Grove, California, United States

Alliance for Research Alliance for Wellness /ID# 273477

Long Beach, California, United States

Nrc Research Institute - Los Angeles /ID# 278450

Los Angeles, California, United States

Excell Research /ID# 273483

Oceanside, California, United States

Inland Psychiatric Medical Group Inc. /ID# 273471

Temecula, California, United States

Sunwise Clinical Research /ID# 278165

Walnut Creek, California, United States

Connecticut Clinical Research - Cromwell /ID# 278116

Cromwell, Connecticut, United States

Cns Healthcare - Jacksonville /ID# 278332

Jacksonville, Florida, United States

GMI Florida - Central Miami Medical Institute /ID# 273486

Miami, Florida, United States

Allied Biomedical Res Inst Inc /ID# 273476

Miami, Florida, United States

Floridian Clinical Research - Miami Lakes /ID# 279379

Miami Lakes, Florida, United States

K2 Medical Research - Orlando - South Orlando Avenue /ID# 273487

Orlando, Florida, United States

Apg Research /ID# 278439

Orlando, Florida, United States

Segal Trials - West Broward Outpatient Research Site /ID# 273496

Tamarac, Florida, United States

Health Synergy Clinical Research /ID# 279384

West Palm Beach, Florida, United States

Trialmed /ID# 278046

Atlanta, Georgia, United States

Atlanta Center for Medical Research /ID# 278827

Atlanta, Georgia, United States

Revive Research Institute - Elgin /ID# 279756

Elgin, Illinois, United States

Benchmark Research /ID# 273490

Shreveport, Louisiana, United States

Pharmasite Research, Inc. /ID# 279163

Baltimore, Maryland, United States

Elixia, LLC /ID# 278446

Springfield, Massachusetts, United States

MSB Neuroscience /ID# 278168

Jackson, Mississippi, United States

Arch Clinical Trials /ID# 273481

St Louis, Missouri, United States

Alivation Research /ID# 279464

Lincoln, Nebraska, United States

Ima Clinical Research Las Vegas (Altea) /ID# 278054

Las Vegas, Nevada, United States

Redbird Research /ID# 279475

Las Vegas, Nevada, United States

Bio Behavioral Health /ID# 273478

Toms River, New Jersey, United States

Integrative Clinical Trials /ID# 278040

Brooklyn, New York, United States

Neurobehavioral Research /ID# 273470

Cedarhurst, New York, United States

Ima Clinical Research - Manhattan /ID# 278941

New York, New York, United States

New Hope Clinical Research - Inpatient unit /ID# 273468

Charlotte, North Carolina, United States

Quest Therapeutics of Avon Lake /ID# 273484

Avon Lake, Ohio, United States

OSU Psychiatry Department /ID# 273495

Columbus, Ohio, United States

Sooner Clinical Research /ID# 273491

Oklahoma City, Oklahoma, United States

Summit Research Network - Portland - Northwest Vaughn Street /ID# 278084

Portland, Oregon, United States

Lehigh Center for Clinical Research /ID# 273466

Allentown, Pennsylvania, United States

FutureSearch Trials of Dallas /ID# 273473

Dallas, Texas, United States

Epic Medical Research - DeSoto /ID# 278045

DeSoto, Texas, United States

Perceptive Pharma Research /ID# 273485

Richmond, Texas, United States

Family Psychiatry Of The Woodlands /ID# 278050

The Woodlands, Texas, United States

Northwest Clinical Research Center /ID# 273480

Bellevue, Washington, United States

Core Clinical Research /ID# 273498

Everett, Washington, United States

INSPIRA Clinical Research /ID# 274670

San Juan, Puerto Rico

BDH Research /ID# 274677