Study of Oral ABBV-932 to Assess Adverse Events and Change in Disease Activity in Adult Participants With Bipolar I or II Disorder
- Conditions
- Bipolar I DisorderBipolar II Disorder
- Interventions
- Drug: Placebo for ABBV-932
- Registration Number
- NCT06605599
- Lead Sponsor
- AbbVie
- Brief Summary
Bipolar disorder is a severe chronic mood disorder that affects up to 4% of the adult population in the United States. This study will assess how safe and effective ABBV-932 is in treating participants 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. Study doctors put participants in 1 of 4 groups, called treatment arms. There is a 1 in 4 chance that a participant will be assigned to placebo. Around 160 adult participants with bipolar I or II disorder will be enrolled in approximately 40 sites worldwide.
Participants will receive oral capsules of ABBV-932 or matching placebo once daily for 6 weeks. The treatment period will be followed by a safety follow-up (SFU) period for 4 weeks.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular weekly 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 160
- Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria for bipolar I or II disorder without psychotic features based on the Mini International Neuropsychiatric Interview (MINI), with a current depressive episode of at least 4 weeks and not exceeding 12 months.
- Have a minimum score of 20 on the 17-item Hamilton Depression Rating Scale (HAMD-17).
- Have a minimum score of 2 on Item 1 of the HAMD-17 at screening.
- Positive urine drug screen (UDS) result at screening.
- Treated with any investigational drug within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to the first dose of study drug, is currently enrolled in another clinical study, or was previously enrolled in this study.
- Current use of any antipsychotic, antidepressant, anticonvulsant, mood stabilizer, herb, or over-the-counter medication with psychoactive potential within 1 week or 5 half-lives of the medication (whichever is longer).
- Prior exposure to ABBV-932 within 90 days prior to baseline.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ABBV-932 Dose B ABBV-932 Participants will receive ABBV-932 Dose B. ABBV-932 Dose C ABBV-932 Participants will receive ABBV-932 Dose C. Placebo for ABBV-932 Placebo for ABBV-932 Participants will receive placebo. ABBV-932 Dose A ABBV-932 Participants will receive ABBV-932 Dose A.
- Primary Outcome Measures
Name Time Method Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score Up to Week 6 The MADRS is a 10-item, clinician-rated scale that evaluates the participant's depressive symptomatology. Each item is scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Clinical Global Impression-Severity - Bipolar Disorder (CGI-S-BP) Up to Week 6 CGI-S-BP is a single-item clinician-reported measure of severity of bipolar disorder. Clinicians are asked to rate the severity of mania, depression, and overall bipolar illness. Response options range from 1 to 7: 1 = normal, not ill through 7 = very severely ill.
Change From Baseline in Functioning Assessment Short Test (FAST) Total Score Up to Week 6 FAST is a clinician-reported outcome measure designed to assess the main functioning problems experienced by psychiatric participants, particularly bipolar participants. The FAST includes 24 items in 6 domains of functioning. Clinicians are asked to respond on a 4-point Likert scale ranging from 0 to 3 (0 = no difficulty and 3 = severe difficulty). Higher scores indicate greater difficulties in functioning.
Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score Up to Week 6 HAM-A is a 14-item, clinician-reported measure used to quantify and categorize the participant's anxiety over the past week. Items are rated on a 5-point Likert rating scale of "absent" (0; if symptoms are absent, insignificant, or clearly due to causes other than anxiety) through "very severe" (4; if symptom is incapacitating). The HAM-A total score ranges from 0 to 56, with higher scores indicating greater anxiety severity.
Trial Locations
- Locations (40)
Harmonex /ID# 267504
🇺🇸Dothan, Alabama, United States
Advanced Research Center /ID# 267716
🇺🇸Anaheim, California, United States
Axiom Research /ID# 267518
🇺🇸Colton, California, United States
Collaborative Neuroscience Research - Garden Grove /ID# 267654
🇺🇸Garden Grove, California, United States
Sun Valley Research Center /ID# 267708
🇺🇸Imperial, California, United States
Alliance for Research Alliance for Wellness /ID# 267492
🇺🇸Long Beach, California, United States
Excell Research /ID# 267541
🇺🇸Oceanside, California, United States
Viking Clinical Research Center - Temecula /ID# 267634
🇺🇸Temecula, California, United States
Accel Research Sites Network - St. Pete /ID# 267463
🇺🇸Largo, Florida, United States
GMI Florida - Central Miami Medical Institute /ID# 267566
🇺🇸Miami, Florida, United States
Allied Biomedical Res Inst Inc /ID# 267481
🇺🇸Miami, Florida, United States
K2 Medical Research - Orlando - South Orlando Avenue /ID# 267567
🇺🇸Orlando, Florida, United States
Segal Trials - West Broward Outpatient Research Site /ID# 267947
🇺🇸Tamarac, Florida, United States
Benchmark Research /ID# 267626
🇺🇸Shreveport, Louisiana, United States
CenExel /ID# 267675
🇺🇸Gaithersburg, Maryland, United States
Arch Clinical Trials /ID# 267507
🇺🇸Saint Louis, Missouri, United States
Oasis Clinical Research, LLC /ID# 267969
🇺🇸Las Vegas, Nevada, United States
Center For Emotional Fitness - Cherry Hill /ID# 267661
🇺🇸Cherry Hill, New Jersey, United States
Bio Behavioral Health /ID# 267493
🇺🇸Toms River, New Jersey, United States
Neurobehavioral Research /ID# 267564
🇺🇸Cedarhurst, New York, United States
New Hope Clinical Research - Inpatient unit /ID# 267465
🇺🇸Charlotte, North Carolina, United States
Quest Therapeutics of Avon Lake /ID# 267558
🇺🇸Avon Lake, Ohio, United States
OSU Psychiatry Department /ID# 267730
🇺🇸Columbus, Ohio, United States
Sooner Clinical Research /ID# 267639
🇺🇸Oklahoma City, Oklahoma, United States
Lehigh Center for Clinical Research /ID# 267451
🇺🇸Allentown, Pennsylvania, United States
Suburban Research Associates - Media /ID# 267621
🇺🇸Media, Pennsylvania, United States
Coastal Carolina Research Center, LLC /ID# 267550
🇺🇸Charleston, South Carolina, United States
FutureSearch Trials of Dallas /ID# 267715
🇺🇸Dallas, Texas, United States
Perceptive Pharma Research /ID# 267563
🇺🇸Richmond, Texas, United States
Grayline Research Center /ID# 267466
🇺🇸Wichita Falls, Texas, United States
Northwest Clinical Research Center /ID# 267505
🇺🇸Bellevue, Washington, United States
Core Clinical Research /ID# 268534
🇺🇸Everett, Washington, United States
Kokura Mental Clinic /ID# 268031
🇯🇵Kitakyushu, Fukuoka, Japan
Kawamura Mental Clinic /ID# 268325
🇯🇵Sapporo, Hokkaido, Japan
Yutaka Clinic /ID# 268026
🇯🇵Sagamihara, Kanagawa, Japan
Kaku Mental Clinic /ID# 268020
🇯🇵Fukuoka, Japan
Kuramitsu Hospital /ID# 268751
🇯🇵Fukuoka, Japan
INSPIRA Clinical Research /ID# 267041
🇵🇷San Juan, Puerto Rico
Instituto De Neurologia Dra. Ivonne Fraga, Psc /ID# 267065
🇵🇷San Juan, Puerto Rico
BDH Research /ID# 267025
🇵🇷San Juan, Puerto Rico