Study of Oral ABBV-932 to Assess Adverse Events and Change in Disease Activity in Adult Participants With Bipolar I or II Disorder

Completed · Phase 2 · Has a placebo group

Conditions studied: Bipolar I Disorder, Bipolar II Disorder

In brief

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.

Key facts

Study ID

NCT06605599

Run by

AbbVie

People needed

161

Starts

2024-10-15

Expected to finish

2025-12-10

Last updated by the study team

2026-01-12

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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 — St Louis, Missouri, United States
• Duplicate_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

Full record on ClinicalTrials.gov

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