Dysautonomia International

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

Purpose

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.

Condition

Bipolar I or II Disorder

Eligibility

Eligible Ages: Between 18 Years and 65 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

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).

Study Design

Phase: Phase 2
Study Type: Interventional
Allocation: N/A
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental ABBV-932	Participants will receive oral ABBV-932 for a 26-week treatment period followed by a 30-day follow-up	Drug: ABBV-932 Oral Capsule

Recruiting Locations

Ima Clinical Research Phoenix (Alea) /ID# 278047
Phoenix, Arizona 85012

Advanced Research Center /ID# 273474
Anaheim, California 92805

Axiom Research /ID# 273482
Colton, California 92324

Collaborative Neuroscience Research - Garden Grove /ID# 273492
Garden Grove, California 92845

Sun Valley Research Center /ID# 273472
Imperial, California 92251

Synergy San Diego /ID# 278340
Lemon Grove, California 91945

Alliance for Research Alliance for Wellness /ID# 273477
Long Beach, California 90807

Nrc Research Institute - Los Angeles /ID# 278450
Los Angeles, California 90015

Excell Research /ID# 273483
Oceanside, California 92056

Inland Psychiatric Medical Group Inc. /ID# 273471
Temecula, California 92591

Sunwise Clinical Research /ID# 278165
Walnut Creek, California 94596

Connecticut Clinical Research - Cromwell /ID# 278116
Cromwell, Connecticut 06416

Cns Healthcare - Jacksonville /ID# 278332
Jacksonville, Florida 32256

GMI Florida - Central Miami Medical Institute /ID# 273486
Miami, Florida 33125

Allied Biomedical Res Inst Inc /ID# 273476
Miami, Florida 33155

Floridian Clinical Research - Miami Lakes /ID# 279379
Miami Lakes, Florida 33016

K2 Medical Research - Orlando - South Orlando Avenue /ID# 273487
Orlando, Florida 32751

Apg Research /ID# 278439
Orlando, Florida 32803

Segal Trials - West Broward Outpatient Research Site /ID# 273496
Tamarac, Florida 33319-4985

Health Synergy Clinical Research /ID# 279384
West Palm Beach, Florida 33407

Trialmed /ID# 278046
Atlanta, Georgia 30328

Atlanta Center for Medical Research /ID# 278827
Atlanta, Georgia 30331

Pharmasite Research, Inc. /ID# 279163
Baltimore, Maryland 21208

Elixia, LLC /ID# 278446
Springfield, Massachusetts 01103

MSB Neuroscience /ID# 278168
Jackson, Mississippi 39216-4643

Arch Clinical Trials /ID# 273481
St Louis, Missouri 63125

Alivation Research /ID# 279464
Lincoln, Nebraska 68526

Ima Clinical Research Las Vegas (Altea) /ID# 278054
Las Vegas, Nevada 89102

Bio Behavioral Health /ID# 273478
Toms River, New Jersey 08755

Integrative Clinical Trials /ID# 278040
Brooklyn, New York 11229

Neurobehavioral Research /ID# 273470
Cedarhurst, New York 11516

Ima Clinical Research - Manhattan /ID# 278941
New York, New York 10036

New Hope Clinical Research - Inpatient unit /ID# 273468
Charlotte, North Carolina 28211

Quest Therapeutics of Avon Lake /ID# 273484
Avon Lake, Ohio 44012

OSU Psychiatry Department /ID# 273495
Columbus, Ohio 43210

Sooner Clinical Research /ID# 273491
Oklahoma City, Oklahoma 73116

Summit Research Network - Portland - Northwest Vaughn Street /ID# 278084
Portland, Oregon 97210

Lehigh Center for Clinical Research /ID# 273466
Allentown, Pennsylvania 18103

FutureSearch Trials of Dallas /ID# 273473
Dallas, Texas 75231

Epic Medical Research - DeSoto /ID# 278045
DeSoto, Texas 75115

Perceptive Pharma Research /ID# 273485
Richmond, Texas 77407

Family Psychiatry Of The Woodlands /ID# 278050
The Woodlands, Texas 77381

Northwest Clinical Research Center /ID# 273480
Bellevue, Washington 98007

Core Clinical Research /ID# 273498
Everett, Washington 98201

INSPIRA Clinical Research /ID# 274670
San Juan, Puerto Rico 00918-3014

BDH Research /ID# 274677
San Juan, Puerto Rico 00927

More Details

Status: Recruiting
Sponsor: AbbVie

Study Contact

ABBVIE CALL CENTER
844-663-3742
abbvieclinicaltrials@abbvie.com