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NCT06605599CompletedPhase 2

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

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

Source: ClinicalTrials.gov · Last updated 14 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
161 (actual)
First submitted
18 Sept 2024
Start date
15 Oct 2024
Primary completion date
12 Nov 2025
Lead sponsor
AbbVie
NCT number
NCT06605599

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 161
  • From 15 Oct 2024 to the primary completion date, 12 Nov 2025
  • 40 sites in 3 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (40)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Kuramitsu Hospital /ID# 268751
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FukuokaJapanUnknown status
Kaku Mental Clinic /ID# 268020
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FukuokaJapanUnknown status
Kokura Mental Clinic /ID# 268031
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KitakyushuJapanUnknown status
Yutaka Clinic /ID# 268026
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SagamiharaJapanUnknown status
Kawamura Mental Clinic /ID# 268325
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SapporoJapanUnknown status
Instituto De Neurologia Dra. Ivonne Fraga, Psc /ID# 267065
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San JuanPuerto RicoUnknown status
INSPIRA Clinical Research /ID# 267041
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San JuanPuerto RicoUnknown status
BDH Research /ID# 267025
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San JuanPuerto RicoUnknown status
Lehigh Center for Clinical Research /ID# 267451
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AllentownUnited StatesUnknown status
Advanced Research Center /ID# 267716
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AnaheimUnited StatesUnknown status
Quest Therapeutics of Avon Lake /ID# 267558
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Avon LakeUnited StatesUnknown status
Northwest Clinical Research Center /ID# 267505
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BellevueUnited StatesUnknown status
Neurobehavioral Research /ID# 267564
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CedarhurstUnited StatesUnknown status
Coastal Carolina Research Center, LLC /ID# 267550
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CharlestonUnited StatesUnknown status
New Hope Clinical Research - Inpatient unit /ID# 267465
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CharlotteUnited StatesUnknown status
Center For Emotional Fitness - Cherry Hill /ID# 267661
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Cherry HillUnited StatesUnknown status
Axiom Research /ID# 267518
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ColtonUnited StatesUnknown status
OSU Psychiatry Department /ID# 267730
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ColumbusUnited StatesUnknown status
FutureSearch Trials of Dallas /ID# 267715
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DallasUnited StatesUnknown status
Harmonex /ID# 267504
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DothanUnited StatesUnknown status
Core Clinical Research /ID# 268534
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EverettUnited StatesUnknown status
CenExel /ID# 267675
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GaithersburgUnited StatesUnknown status
Collaborative Neuroscience Research - Garden Grove /ID# 267654
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Garden GroveUnited StatesUnknown status
Sun Valley Research Center /ID# 267708
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ImperialUnited StatesUnknown status
Accel Research Sites Network - St. Pete /ID# 267463
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LargoUnited StatesUnknown status
Duplicate_Oasis Clinical Research, LLC /ID# 267969
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Las VegasUnited StatesUnknown status
Alliance for Research Alliance for Wellness /ID# 267492
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Long BeachUnited StatesUnknown status
Suburban Research Associates - Media /ID# 267621
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MediaUnited StatesUnknown status
GMI Florida - Central Miami Medical Institute /ID# 267566
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MiamiUnited StatesUnknown status
Allied Biomedical Res Inst Inc /ID# 267481
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MiamiUnited StatesUnknown status
Excell Research /ID# 267541
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OceansideUnited StatesUnknown status
Sooner Clinical Research /ID# 267639
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Oklahoma CityUnited StatesUnknown status
K2 Medical Research - Orlando - South Orlando Avenue /ID# 267567
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OrlandoUnited StatesUnknown status
Perceptive Pharma Research /ID# 267563
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RichmondUnited StatesUnknown status
Benchmark Research /ID# 267626
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ShreveportUnited StatesUnknown status
Arch Clinical Trials /ID# 267507
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St LouisUnited StatesUnknown status
Segal Trials - West Broward Outpatient Research Site /ID# 267947
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TamaracUnited StatesUnknown status
Viking Clinical Research Center - Temecula /ID# 267634
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TemeculaUnited StatesUnknown status
Bio Behavioral Health /ID# 267493
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Toms RiverUnited StatesUnknown status
Grayline Research Center /ID# 267466
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Wichita FallsUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.