Recruiting

Phase 2

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

Sponsor:

AbbVie

Code:

NCT07220460

Conditions

Bipolar I or II Disorder

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

ABBV-932

Study Details

Brief 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.

Conditions

Bipolar I or II Disorder

Study ID

NCT07220460

Start date

Sep 30, 2025

Status verified date

Jun, 2026

Completion date

Apr, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

200 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ABBV-932

Participants will receive oral ABBV-932 for a 26-week treatment period followed by a 30-day follow-up

Interventions

ABBV-932

Oral Capsule

Primary outcome measure

Number of Participants Experiencing Adverse Events [ Time Frame: Up to approximately 29 weeks ]
Number of Participants with Abnormal Change From Baseline in Vital Sign Measurements [ Time Frame: Up to week 26 ]
Number of Participants with Change from Baseline in Electrocardiogram (ECG) [ Time Frame: Up to week 26 ]
Number of Participants with Abnormal Change in Clinical Laboratory Test Results Like Hematology will be Assessed [ Time Frame: Up to week 26 ]
Change From Baseline in Simpson-Angus Scale (SAS) [ Time Frame: Up to week 26 ]
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) [ Time Frame: Up to week 26 ]
Change From Baseline in Barnes Akathisia Rating Scale (BARS) [ Time Frame: Up to week 26 ]
Change from Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Up to week 26 ]
Change From Baseline in the Epworth Sleepiness Scale (ESS) [ Time Frame: Up to week 26 ]
Change From Baseline in the Young Mania Rating Scale (YMRS) [ Time Frame: Up to week 26 ]
Number of Participants with Abnormal Change in Ocular Examination [ Time Frame: Up to week 26 ]

Central Contacts and Locations

Central contacts

ABBVIE CALL CENTER

844-663-3742 abbvieclinicaltrials@abbvie.com

Locations

Ima Clinical Research Phoenix (Alea) /ID# 278047

Recruiting

Phoenix, Arizona, United States, 85012

Advanced Research Center /ID# 273474

Recruiting

Anaheim, California, United States, 92805

Axiom Research /ID# 273482

Recruiting

Colton, California, United States, 92324

Collaborative Neuroscience Research - Garden Grove /ID# 273492

Recruiting

Garden Grove, California, United States, 92845

Sun Valley Research Center /ID# 273472

Recruiting

Imperial, California, United States, 92251

Synergy San Diego /ID# 278340

Recruiting

Lemon Grove, California, United States, 91945

Alliance for Research Alliance for Wellness /ID# 273477

Recruiting

Long Beach, California, United States, 90807

Nrc Research Institute - Los Angeles /ID# 278450

Recruiting

Los Angeles, California, United States, 90015

Excell Research /ID# 273483

Recruiting

Oceanside, California, United States, 92056

Inland Psychiatric Medical Group /ID# 273471

Recruiting

Temecula, California, United States, 92591

Sunwise Clinical Research /ID# 278165

Recruiting

Walnut Creek, California, United States, 94596

Connecticut Clinical Research - Cromwell /ID# 278116

Recruiting

Cromwell, Connecticut, United States, 06416

Clinical Neuroscience Solutions Healthcare - Jacksonville /ID# 278332

Recruiting

Jacksonville, Florida, United States, 32256

GMI Florida - Central Miami Medical Institute /ID# 273486

Recruiting

Miami, Florida, United States, 33125

Allied Biomedical Res Inst Inc /ID# 273476

Recruiting

Miami, Florida, United States, 33155

Floridian Clinical Research - Miami Lakes /ID# 279379

Recruiting

Miami Lakes, Florida, United States, 33016

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

Recruiting

Orlando, Florida, United States, 32751

Apg Research /ID# 278439

Recruiting

Orlando, Florida, United States, 32803

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

Recruiting

Tamarac, Florida, United States, 33319-4985

Health Synergy Clinical Research /ID# 279384

Recruiting

West Palm Beach, Florida, United States, 33407

Trialmed /ID# 278046

Recruiting

Atlanta, Georgia, United States, 30328

Atlanta Center for Medical Research /ID# 278827

Recruiting

Atlanta, Georgia, United States, 30331

Revive Research Institute - Elgin /ID# 279756

Recruiting

Elgin, Illinois, United States, 60123

Pharmasite Research, Inc. /ID# 279163

Recruiting

Baltimore, Maryland, United States, 21208

Elixia - Springfield /ID# 278446

Recruiting

Springfield, Massachusetts, United States, 01103

MSB Neuroscience /ID# 278168

Recruiting

Jackson, Mississippi, United States, 39216-4643

Arch Clinical Trials /ID# 273481

Recruiting

St Louis, Missouri, United States, 63125

Alivation Research /ID# 279464

Recruiting

Lincoln, Nebraska, United States, 68526

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

Recruiting

Las Vegas, Nevada, United States, 89102

Redbird Research /ID# 279475

Recruiting

Las Vegas, Nevada, United States, 89119

Bio Behavioral Health /ID# 273478

Recruiting

Toms River, New Jersey, United States, 08755

Integrative Clinical Trials /ID# 278040

Recruiting

Brooklyn, New York, United States, 11229

Neurobehavioral Research /ID# 273470

Recruiting

Cedarhurst, New York, United States, 11516

Ima Clinical Research - Manhattan /ID# 278941

Recruiting

New York, New York, United States, 10036

New Hope Clinical Research - Inpatient unit /ID# 273468

Recruiting

Charlotte, North Carolina, United States, 28211

Quest Therapeutics of Avon Lake /ID# 273484

Recruiting

Avon Lake, Ohio, United States, 44012

OSU Psychiatry Department /ID# 273495

Recruiting

Columbus, Ohio, United States, 43210

Sooner Clinical Research /ID# 273491

Recruiting

Oklahoma City, Oklahoma, United States, 73116

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

Recruiting

Portland, Oregon, United States, 97210

Lehigh Center for Clinical Research /ID# 273466

Recruiting

Allentown, Pennsylvania, United States, 18103

FutureSearch Trials of Dallas /ID# 273473

Recruiting

Dallas, Texas, United States, 75231

Epic Medical Research - DeSoto /ID# 278045

Recruiting

DeSoto, Texas, United States, 75115

Perceptive Pharma Research /ID# 273485

Recruiting

Richmond, Texas, United States, 77407

Family Psychiatry Of The Woodlands /ID# 278050

Recruiting

The Woodlands, Texas, United States, 77381

Northwest Clinical Research Center /ID# 273480

Recruiting

Bellevue, Washington, United States, 98007

Core Clinical Research /ID# 273498

Recruiting

Everett, Washington, United States, 98201

More Information

Sponsor

AbbVie

Last update posted

Jun 18, 2026

Last verified

Jun, 2026

Keywords

Bipolar I or II Disorder

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-19. This information was provided to ClinicalTrials.gov by AbbVie on 2026-06-18.