Clinical trial NCT06605599: Study of Oral ABBV-932 to Assess Adverse Events and Change in Disease Activity in Adult Participants With Bipolar I or II Disorder
Official title: Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Fixed-dose Study to Evaluate the Efficacy, Safety, and Tolerability of ABBV-932 in Subjects With Depressive Episodes Associated With Bipolar I or II Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Bipolar I Disorder
Bipolar II Disorder
Keywords: Bipolar I Disorder
Bipolar II Disorder
Bipolar Disorder
ABBV-932
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2024-09-20
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
timeFrame: Up to Week 6
Secondary outcomes:
measure: Change From Baseline in Clinical Global Impression-Severity - Bipolar Disorder (CGI-S-BP)
timeFrame: Up to Week 6
measure: Change From Baseline in Functioning Assessment Short Test (FAST) Total Score
timeFrame: Up to Week 6
measure: Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score
timeFrame: Up to Week 6
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Harmonex /ID# 267504
state: Alabama
city: Anaheim
country: United States
facility: Advanced Research Center /ID# 267716
state: California
city: Colton
country: United States
facility: Axiom Research /ID# 267518
state: California
city: Garden Grove
country: United States
facility: Collaborative Neuroscience Research - Garden Grove /ID# 267654
state: California
city: Imperial
country: United States
facility: Sun Valley Research Center /ID# 267708
state: California
city: Long Beach
country: United States
facility: Alliance for Research Alliance for Wellness /ID# 267492
state: California
city: Oceanside
country: United States
facility: Excell Research /ID# 267541
state: California
city: Temecula
country: United States
facility: Viking Clinical Research Center - Temecula /ID# 267634
state: California
city: Largo
country: United States
facility: Accel Research Sites Network - St. Pete /ID# 267463
state: Florida
city: Miami
country: United States
facility: GMI Florida - Central Miami Medical Institute /ID# 267566
state: Florida
city: Miami
country: United States
facility: Allied Biomedical Res Inst Inc /ID# 267481
state: Florida
city: Orlando
country: United States
facility: K2 Medical Research - Orlando - South Orlando Avenue /ID# 267567
state: Florida
city: Tamarac
country: United States
facility: Segal Trials - West Broward Outpatient Research Site /ID# 267947
state: Florida
city: Shreveport
country: United States
facility: Benchmark Research /ID# 267626
state: Louisiana
city: Gaithersburg
country: United States
facility: CenExel /ID# 267675
state: Maryland
city: Saint Louis
country: United States
facility: Arch Clinical Trials /ID# 267507
state: Missouri
city: Las Vegas
country: United States
facility: Oasis Clinical Research, LLC /ID# 267969
state: Nevada
city: Cherry Hill
country: United States
facility: Center For Emotional Fitness - Cherry Hill /ID# 267661
state: New Jersey
city: Toms River
country: United States
facility: Bio Behavioral Health /ID# 267493
state: New Jersey
city: Cedarhurst
country: United States
facility: Neurobehavioral Research /ID# 267564
state: New York
city: Charlotte
country: United States
facility: New Hope Clinical Research - Inpatient unit /ID# 267465
state: North Carolina
city: Avon Lake
country: United States
facility: Quest Therapeutics of Avon Lake /ID# 267558
state: Ohio
city: Columbus
country: United States
facility: OSU Psychiatry Department /ID# 267730
state: Ohio
city: Oklahoma City
country: United States
facility: Sooner Clinical Research /ID# 267639
state: Oklahoma
city: Allentown
country: United States
facility: Lehigh Center for Clinical Research /ID# 267451
state: Pennsylvania
city: Media
country: United States
facility: Suburban Research Associates - Media /ID# 267621
state: Pennsylvania
city: Charleston
country: United States
facility: Coastal Carolina Research Center, LLC /ID# 267550
state: South Carolina
city: Dallas
country: United States
facility: FutureSearch Trials of Dallas /ID# 267715
state: Texas
city: Richmond
country: United States
facility: Perceptive Pharma Research /ID# 267563
state: Texas
city: Wichita Falls
country: United States
facility: Grayline Research Center /ID# 267466
state: Texas
city: Bellevue
country: United States
facility: Northwest Clinical Research Center /ID# 267505
state: Washington
city: Everett
country: United States
facility: Core Clinical Research /ID# 268534
state: Washington
city: Kitakyushu
country: Japan
facility: Kokura Mental Clinic /ID# 268031
state: Fukuoka
city: Sapporo
country: Japan
facility: Kawamura Mental Clinic /ID# 268325
state: Hokkaido
city: Sagamihara
country: Japan
facility: Yutaka Clinic /ID# 268026
state: Kanagawa
city: Fukuoka
country: Japan
facility: Kaku Mental Clinic /ID# 268020
city: Fukuoka
country: Japan
facility: Kuramitsu Hospital /ID# 268751
city: San Juan
country: Puerto Rico
facility: INSPIRA Clinical Research /ID# 267041
city: San Juan
country: Puerto Rico
facility: Instituto De Neurologia Dra. Ivonne Fraga, Psc /ID# 267065
city: San Juan
country: Puerto Rico
facility: BDH Research /ID# 267025
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: