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

NCT07220460 | Recruiting Phase 2 FDA Drug

• 1 other identifier: M25-456
• Study Type: interventional
• Target: 200
• Locations: 2 countries
• Sites: 47

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

Keywords

Bipolar I or II Disorder

Outcome Measures

Primary Outcomes (11)

• Number of Participants Experiencing Adverse Events

  An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

  Up to approximately 29 weeks

• Number of Participants with Abnormal Change From Baseline in Vital Sign Measurements

  Number of participants with abnormal change from baseline in vital sign measurements like systolic and diastolic blood pressure will be assessed.

  Up to week 26

• Number of Participants with Change from Baseline in Electrocardiogram (ECG)

  12-lead resting ECG will be recorded.

  Up to week 26

• Number of Participants with Abnormal Change in Clinical Laboratory Test Results Like Hematology will be Assessed

  Number of participants with abnormal change in clinical laboratory test results like hematology will be assessed.

  Up to week 26

• Change From Baseline in Simpson-Angus Scale (SAS)

  SAS (Simpson-Angus Scale): is a 10-item rating scale for assessment of antipsychotic-induced parkinsonism in both clinical practice and research settings. Minimum: 0 (no symptoms) Maximum: 40 (very severe symptoms; 10 items scored 0-4 each).

  Up to week 26

• Change From Baseline in Abnormal Involuntary Movement Scale (AIMS)

  AIMS (Abnormal Involuntary Movement Scale): assesses abnormal involuntary movements, such as tardive dyskinesia, associated with antipsychotic drugs; it measures facial, oral, extremities, and trunk movements, as well as the participant's awareness of abnormal movements. Minimum: 0 (no abnormal movements) Maximum: 42 (most severe; 7 items scored 0-4 each), some versions use 0-4 on 10 items for a max of 40/40.

  Up to week 26

• Change From Baseline in Barnes Akathisia Rating Scale (BARS)

  BARS (Barnes Akathisia Rating Scale): is a 4-item rating scale used to assess drug-induced akathisia. The scale comprises items for rating the observable restless movements that characterize the condition, the subjective awareness of restlessness, and any distress associated with the akathisia. Minimum: 0 (no akathisia) Maximum: 14 (severe akathisia; 4 items scored, most items 0-3 or 0-5)

  Up to week 26

• Change from Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS)

  C-SSRS rates an individual's degree of suicidal ideation (SI) and behaviors on a scale, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent."

  Up to week 26

• Change From Baseline in the Epworth Sleepiness Scale (ESS)

  ESS (Epworth Sleepiness Scale): is a scale that is intended to measure daytime sleepiness. Minimum: 0 (no sleepiness) Maximum: 24 (severe sleepiness; 8 items scored 0-3 each)

  Up to week 26

• Change From Baseline in the Young Mania Rating Scale (YMRS)

  The YMRS (Young Mania Rating Scale): is an 11-item, clinician-rated scale that assesses manic symptoms based on the participant's perception of their condition over the previous 48 hours, as well as the physician's clinical observations during the interview. Minimum: 0 (no mania) Maximum: 60 (severe mania; 11 items, some scored 0-4, others 0-8)

  Up to week 26

• Number of Participants with Abnormal Change in Ocular Examination

  Number of participants with abnormal change in ocular examinations in areas like best corrected visual acuity (BCVA), and refraction.

  Up to week 26

Study Arms (1)

ABBV-932

EXPERIMENTAL

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

Drug: ABBV-932

Interventions

ABBV-932 DRUG

Oral Capsule

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:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• AbbVie: lead

Study Sites (47)

Ima Clinical Research Phoenix (Alea) /ID# 278047

Phoenix, Arizona, 85012, United States

RECRUITING

Advanced Research Center /ID# 273474

Anaheim, California, 92805, United States

RECRUITING

Axiom Research /ID# 273482

Colton, California, 92324, United States

RECRUITING

Collaborative Neuroscience Research - Garden Grove /ID# 273492

Garden Grove, California, 92845, United States

RECRUITING

Sun Valley Research Center /ID# 273472

Imperial, California, 92251, United States

RECRUITING

Synergy San Diego /ID# 278340

Lemon Grove, California, 91945, United States

RECRUITING

Alliance for Research Alliance for Wellness /ID# 273477

Long Beach, California, 90807, United States

RECRUITING

Nrc Research Institute - Los Angeles /ID# 278450

Los Angeles, California, 90015, United States

RECRUITING

Excell Research /ID# 273483

Oceanside, California, 92056, United States

RECRUITING

Inland Psychiatric Medical Group Inc. /ID# 273471

Temecula, California, 92591, United States

RECRUITING

Sunwise Clinical Research /ID# 278165

Walnut Creek, California, 94596, United States

RECRUITING

Connecticut Clinical Research - Cromwell /ID# 278116

Cromwell, Connecticut, 06416, United States

RECRUITING

Cns Healthcare - Jacksonville /ID# 278332

Jacksonville, Florida, 32256, United States

RECRUITING

GMI Florida - Central Miami Medical Institute /ID# 273486

Miami, Florida, 33125, United States

RECRUITING

Allied Biomedical Res Inst Inc /ID# 273476

Miami, Florida, 33155, United States

RECRUITING

Floridian Clinical Research - Miami Lakes /ID# 279379

Miami Lakes, Florida, 33016, United States

RECRUITING

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

Orlando, Florida, 32751, United States

RECRUITING

Apg Research /ID# 278439

Orlando, Florida, 32803, United States

RECRUITING

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

Tamarac, Florida, 33319-4985, United States

RECRUITING

Health Synergy Clinical Research /ID# 279384

West Palm Beach, Florida, 33407, United States

RECRUITING

Trialmed /ID# 278046

Atlanta, Georgia, 30328, United States

RECRUITING

Atlanta Center for Medical Research /ID# 278827

Atlanta, Georgia, 30331, United States

RECRUITING

Benchmark Research /ID# 273490

Shreveport, Louisiana, 71101, United States

COMPLETED

Pharmasite Research, Inc. /ID# 279163

Baltimore, Maryland, 21208, United States

RECRUITING

Elixia, LLC /ID# 278446

Springfield, Massachusetts, 01103, United States

RECRUITING

MSB Neuroscience /ID# 278168

Jackson, Mississippi, 39216-4643, United States

RECRUITING

Arch Clinical Trials /ID# 273481

St Louis, Missouri, 63125, United States

RECRUITING

Alivation Research /ID# 279464

Lincoln, Nebraska, 68526, United States

RECRUITING

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

Las Vegas, Nevada, 89102, United States

RECRUITING

Bio Behavioral Health /ID# 273478

Toms River, New Jersey, 08755, United States

RECRUITING

Integrative Clinical Trials /ID# 278040

Brooklyn, New York, 11229, United States

RECRUITING

Neurobehavioral Research /ID# 273470

Cedarhurst, New York, 11516, United States

RECRUITING

Ima Clinical Research - Manhattan /ID# 278941

New York, New York, 10036, United States

RECRUITING

New Hope Clinical Research - Inpatient unit /ID# 273468

Charlotte, North Carolina, 28211, United States

RECRUITING

Quest Therapeutics of Avon Lake /ID# 273484

Avon Lake, Ohio, 44012, United States

RECRUITING

OSU Psychiatry Department /ID# 273495

Columbus, Ohio, 43210, United States

RECRUITING

Sooner Clinical Research /ID# 273491

Oklahoma City, Oklahoma, 73116, United States

RECRUITING

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

Portland, Oregon, 97210, United States

RECRUITING

Lehigh Center for Clinical Research /ID# 273466

Allentown, Pennsylvania, 18103, United States

RECRUITING

FutureSearch Trials of Dallas /ID# 273473

Dallas, Texas, 75231, United States

RECRUITING

Epic Medical Research - DeSoto /ID# 278045

DeSoto, Texas, 75115, United States

RECRUITING

Perceptive Pharma Research /ID# 273485

Richmond, Texas, 77407, United States

RECRUITING

Family Psychiatry Of The Woodlands /ID# 278050

The Woodlands, Texas, 77381, United States

RECRUITING

Northwest Clinical Research Center /ID# 273480

Bellevue, Washington, 98007, United States

RECRUITING

Core Clinical Research /ID# 273498

Everett, Washington, 98201, United States

RECRUITING

INSPIRA Clinical Research /ID# 274670

San Juan, 00918-3014, Puerto Rico

RECRUITING

BDH Research /ID# 274677

San Juan, 00927, Puerto Rico

RECRUITING

Related Links

• Related Info

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Central Study Contacts

ABBVIE CALL CENTER

CONTACT

844-663-3742; abbvieclinicaltrials@abbvie.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2025
• First Posted: October 24, 2025
• Study Start: September 30, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: March 31, 2026

Record last verified: 2026-03

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

PR (2); US (45)