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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
161
Oral Capsule
Oral Capsule
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
Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
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.
Time frame: Up to Week 6
Change From Baseline in Clinical Global Impression-Severity - Bipolar Disorder (CGI-S-BP)
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.
Time frame: Up to Week 6
Change From Baseline in Functioning Assessment Short Test (FAST) Total Score
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.
Time frame: Up to Week 6
Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score
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.
Time frame: Up to Week 6
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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
...and 30 more locations