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NCT07220460PHASE2Recruiting

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

AbbVie

Start Date

9/30/2025

Completion Date

4/1/2027

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.

Eligibility Criteria

Age Range: 18 years to 65 years

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. * History of stable psychiatric comorbidities (e.g., PTSD, OCD) may be included provided these conditions have not required intervention with a prohibited medication within the past 12 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 (e.g., participants with eGFR \< 30 mL/min), hepatic (including history of severe hepatic impairment), gastrointestinal, or neurological disorder. If there is a history of such disease (except malignancy), 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.

Interventions

DRUG

ABBV-932

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Conditions

Bipolar I or II Disorder

Locations

Ima Clinical Research Phoenix (Alea) /ID# 278047

Phoenix, Arizona 85012

United States

Advanced Research Center /ID# 273474

Anaheim, California 92805

United States

Axiom Research /ID# 273482

Colton, California 92324

United States

Collaborative Neuroscience Research - Garden Grove /ID# 273492

Garden Grove, California 92845

United States

Sun Valley Research Center /ID# 273472

Imperial, California 92251

United States

Synergy San Diego /ID# 278340

Lemon Grove, California 91945

United States

Alliance for Research Alliance for Wellness /ID# 273477

Long Beach, California 90807

United States

Nrc Research Institute - Los Angeles /ID# 278450

Los Angeles, California 90015

United States

Excell Research /ID# 273483

Oceanside, California 92056

United States

Inland Psychiatric Medical Group /ID# 273471

Temecula, California 92591

United States

Sunwise Clinical Research /ID# 278165

Walnut Creek, California 94596

United States

Connecticut Clinical Research - Cromwell /ID# 278116

Cromwell, Connecticut 06416

United States

Clinical Neuroscience Solutions Healthcare - Jacksonville /ID# 278332

Jacksonville, Florida 32256

United States

GMI Florida - Central Miami Medical Institute /ID# 273486

Miami, Florida 33125

United States

Allied Biomedical Res Inst Inc /ID# 273476

Miami, Florida 33155

United States

Floridian Clinical Research - Miami Lakes /ID# 279379

Miami Lakes, Florida 33016

United States

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

Orlando, Florida 32751

United States

Apg Research /ID# 278439

Orlando, Florida 32803

United States

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

Tamarac, Florida 33319-4985

United States

Health Synergy Clinical Research /ID# 279384

West Palm Beach, Florida 33407

United States

Trialmed /ID# 278046

Atlanta, Georgia 30328

United States

Atlanta Center for Medical Research /ID# 278827

Atlanta, Georgia 30331

United States

Revive Research Institute - Elgin /ID# 279756

Elgin, Illinois 60123

United States

Benchmark Research /ID# 273490

Shreveport, Louisiana 71101

United States

Pharmasite Research, Inc. /ID# 279163

Baltimore, Maryland 21208

United States

Elixia - Springfield /ID# 278446

Springfield, Massachusetts 01103

United States

MSB Neuroscience /ID# 278168

Jackson, Mississippi 39216-4643

United States

Arch Clinical Trials /ID# 273481

St Louis, Missouri 63125

United States

Alivation Research /ID# 279464

Lincoln, Nebraska 68526

United States

Ima Clinical Research Las Vegas (SMO/Network/Consortium) /ID# 278054

Las Vegas, Nevada 89102

United States

Redbird Research /ID# 279475

Las Vegas, Nevada 89119

United States

Bio Behavioral Health /ID# 273478

Toms River, New Jersey 08755

United States

Integrative Clinical Trials /ID# 278040

Brooklyn, New York 11229

United States

Neurobehavioral Research /ID# 273470

Cedarhurst, New York 11516

United States

Ima Clinical Research - Manhattan /ID# 278941

New York, New York 10036

United States

New Hope Clinical Research - Inpatient unit /ID# 273468

Charlotte, North Carolina 28211

United States

Quest Therapeutics of Avon Lake /ID# 273484

Avon Lake, Ohio 44012

United States

OSU Psychiatry Department /ID# 273495

Columbus, Ohio 43210

United States

Sooner Clinical Research /ID# 273491

Oklahoma City, Oklahoma 73116

United States

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

Portland, Oregon 97210

United States

Lehigh Center for Clinical Research /ID# 273466

Allentown, Pennsylvania 18103

United States

FutureSearch Trials of Dallas /ID# 273473

Dallas, Texas 75231

United States

Epic Medical Research - DeSoto /ID# 278045

DeSoto, Texas 75115

United States

Perceptive Pharma Research /ID# 273485

Richmond, Texas 77407

United States

Family Psychiatry Of The Woodlands /ID# 278050

The Woodlands, Texas 77381

United States

Northwest Clinical Research Center /ID# 273480

Bellevue, Washington 98007

United States

Core Clinical Research /ID# 273498

Everett, Washington 98201

United States

Inspira Clinical Research /ID# 274670

San Juan, 00918-3014

Puerto Rico

BDH Research /ID# 274677

San Juan, 00927

Puerto Rico