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 |
|
Recruiting Locations
Ima Clinical Research Phoenix (Alea) /ID# 278047
Phoenix 5308655, Arizona 5551752 85012
Phoenix 5308655, Arizona 5551752 85012
Advanced Research Center /ID# 273474
Anaheim 5323810, California 5332921 92805
Anaheim 5323810, California 5332921 92805
Axiom Research /ID# 273482
Colton 5338783, California 5332921 92324
Colton 5338783, California 5332921 92324
Collaborative Neuroscience Research - Garden Grove /ID# 273492
Garden Grove 5351515, California 5332921 92845
Garden Grove 5351515, California 5332921 92845
Sun Valley Research Center /ID# 273472
Imperial 5359052, California 5332921 92251
Imperial 5359052, California 5332921 92251
Synergy San Diego /ID# 278340
Lemon Grove 5365893, California 5332921 91945
Lemon Grove 5365893, California 5332921 91945
Alliance for Research Alliance for Wellness /ID# 273477
Long Beach 5367929, California 5332921 90807
Long Beach 5367929, California 5332921 90807
Excell Research /ID# 273483
Oceanside 5378771, California 5332921 92056
Oceanside 5378771, California 5332921 92056
Viking Clinical Research Center - Temecula /ID# 273471
Temecula 5401395, California 5332921 92591
Temecula 5401395, California 5332921 92591
Sunwise Clinical Research /ID# 278165
Walnut Creek 5406990, California 5332921 94596
Walnut Creek 5406990, California 5332921 94596
Cns Healthcare - Jacksonville /ID# 278332
Jacksonville 4160021, Florida 4155751 32256
Jacksonville 4160021, Florida 4155751 32256
GMI Florida - Central Miami Medical Institute /ID# 273486
Miami 4164138, Florida 4155751 33125
Miami 4164138, Florida 4155751 33125
Allied Biomedical Res Inst Inc /ID# 273476
Miami 4164138, Florida 4155751 33155
Miami 4164138, Florida 4155751 33155
K2 Medical Research - Orlando - South Orlando Avenue /ID# 273487
Orlando 4167147, Florida 4155751 32751
Orlando 4167147, Florida 4155751 32751
Segal Trials - West Broward Outpatient Research Site /ID# 273496
Tamarac 4174738, Florida 4155751 33319-4985
Tamarac 4174738, Florida 4155751 33319-4985
Benchmark Research /ID# 273490
Shreveport 4341513, Louisiana 4331987 71101
Shreveport 4341513, Louisiana 4331987 71101
Elixia, LLC /ID# 278446
Springfield 4951788, Massachusetts 6254926 01103
Springfield 4951788, Massachusetts 6254926 01103
Arch Clinical Trials /ID# 273481
St Louis 4407066, Missouri 4398678 63125
St Louis 4407066, Missouri 4398678 63125
Bio Behavioral Health /ID# 273478
Toms River 4504476, New Jersey 5101760 08755
Toms River 4504476, New Jersey 5101760 08755
Neurobehavioral Research /ID# 273470
Cedarhurst 5111974, New York 5128638 11516
Cedarhurst 5111974, New York 5128638 11516
New Hope Clinical Research - Inpatient unit /ID# 273468
Charlotte 4460243, North Carolina 4482348 28211
Charlotte 4460243, North Carolina 4482348 28211
Quest Therapeutics of Avon Lake /ID# 273484
Avon Lake 5146286, Ohio 5165418 44012
Avon Lake 5146286, Ohio 5165418 44012
OSU Psychiatry Department /ID# 273495
Columbus 4509177, Ohio 5165418 43210
Columbus 4509177, Ohio 5165418 43210
Sooner Clinical Research /ID# 273491
Oklahoma City 4544349, Oklahoma 4544379 73116
Oklahoma City 4544349, Oklahoma 4544379 73116
Perceptive Pharma Research /ID# 273485
Richmond 4722684, Texas 4736286 77407
Richmond 4722684, Texas 4736286 77407
Northwest Clinical Research Center /ID# 273480
Bellevue 5786882, Washington 5815135 98007
Bellevue 5786882, Washington 5815135 98007
More Details
- Status
- Recruiting
- Sponsor
- AbbVie