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NCT07220460Active, not recruitingPhase 2

Study to Assess the Adverse Events of Oral ABBV-932 in Adult Participants With Depressive Episodes Associated With Bipolar I or II Disorder

Multicenter, Open-label Study to Evaluate the Long-term Safety and Tolerability of ABBV-932 in Subjects With Depressive Episodes Associated With Bipolar I or II Disorder

Source: ClinicalTrials.gov · Last updated 23 Sept 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. The purpose of this study is to assess how safe and effective ABBV-932 is in treating participants with depressive episodes associated 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. Participants with bipolar I or II disorder who are currently experiencing a depressive episode will enter the study and be treated with open-label ABBV-932. Approximately 200 adult participants with bipolar I or II disorder will be enrolled in approximately 50 sites in the United States and Puerto Rico. Participants will receive oral capsules of ABBV-932 for a 26-week treatment period. The treatment period will be followed by a safety follow-up (SFU) period of 30 days. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regularly scheduled 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)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
84 (actual)
First submitted
26 Sept 2025
Start date
30 Sept 2025
Primary completion date
31 Mar 2027
Lead sponsor
AbbVie
NCT number
NCT07220460

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 84
  • From 30 Sept 2025 to the primary completion date, 31 Mar 2027
  • 49 sites in 2 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.

Other illness

  • History of an allergic reaction or significant sensitivity to constituents of the study drug (and its excipients) and/or other products in the same class.

Lab values

  • A concurrent medical condition that might interfere with the conduct of the study, confound the interpretation of the study results, or endanger the subject's well-being. This includes any unstable condition, history or evidence of malignancy (other than treated basal or squamous cell carcinoma), or any significant hematologic, endocrine, cardiovascular, respiratory, renal impairment or disease (e.g., participants with eGFR \< 30 mL/min), hepatic (including history of severe hepatic impairment), gastrointestinal, or neurological disorder. If there is a history of such disease (except malignancy), but the condition has been stable for more than 1 year, does not require treatment with prohibited medications, and is judged by the investigator not to interfere with participation in the study, the subject may be included.

Other

  • A total score greater than 12 on the Young Mania Rating Scale (YMRS) at baseline.

Who the study is looking for

  • Body Mass Index (BMI) \>= 18.0 to \<= 40.0 kg/m\^2, inclusive.
  • Participants who currently meet the Diagnostic and Statistical Manual of Mental Disorders treatment (DSM-5-TR) criteria for bipolar I or II disorder without psychotic features based on the Mini International Neuropsychiatric Interview (MINI 7.0.2), currently experiencing a depressive episode of at least 4 weeks and not exceeding 12 months.
  • Normal physical examination findings, clinical laboratory test results, vital signs, and 12-lead ECG results at screening or abnormal results that are judged not clinically significant by the investigator and documented as such in the eCRF
  • Participant with the following psychiatric history:
    • No history of psychiatric hospitalization (inpatient or intensive outpatient) in the past 3 months prior to screening.
    • No lifetime history of schizophrenia, other psychotic disorders, dissociative disorders, or neurocognitive disorders.
    • No history of moderate or severe substance use disorder (except nicotine) in the past 6 months prior to screening.
    • History of stable psychiatric comorbidities (e.g., PTSD, OCD) may be included provided these conditions have not required intervention with a prohibited medication within the past 12 months prior to Screening.

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

Full criteria on ClinicalTrials.gov

Sites (49)

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

SiteCityCountrySite status
Inspira Clinical Research /ID# 274670
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San JuanPuerto RicoUnknown status
BDH Research /ID# 274677
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San JuanPuerto RicoUnknown status
Lehigh Center for Clinical Research /ID# 273466
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AllentownUnited StatesUnknown status
Advanced Research Center /ID# 273474
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AnaheimUnited StatesUnknown status
Atlanta Center for Medical Research /ID# 278827
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AtlantaUnited StatesUnknown status
Trialmed /ID# 278046
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AtlantaUnited StatesUnknown status
Quest Therapeutics of Avon Lake /ID# 273484
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Avon LakeUnited StatesUnknown status
Pharmasite Research, Inc. /ID# 279163
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BaltimoreUnited StatesUnknown status
Northwest Clinical Research Center /ID# 273480
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BellevueUnited StatesUnknown status
Integrative Clinical Trials /ID# 278040
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BrooklynUnited StatesUnknown status
Neurobehavioral Research /ID# 273470
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CedarhurstUnited StatesUnknown status
New Hope Clinical Research /ID# 273468
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CharlotteUnited StatesUnknown status
Axiom Research /ID# 273482
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ColtonUnited StatesUnknown status
OSU Psychiatry Department /ID# 273495
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ColumbusUnited StatesUnknown status
Connecticut Clinical Research - Cromwell /ID# 278116
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CromwellUnited StatesUnknown status
Future Search Trials of Dallas /ID# 273473
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DallasUnited StatesUnknown status
Epic Medical Research - DeSoto /ID# 278045
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DeSotoUnited StatesUnknown status
Revive Research Institute - Elgin /ID# 279756
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ElginUnited StatesUnknown status
Core Clinical Research /ID# 273498
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EverettUnited StatesUnknown status
Collaborative Neuroscience Research - Garden Grove /ID# 273492
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Garden GroveUnited StatesUnknown status
Sun Valley Research Center /ID# 273472
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ImperialUnited StatesUnknown status
MSB Neuroscience /ID# 278168
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JacksonUnited StatesUnknown status
Clinical Neuroscience Solutions Healthcare - Jacksonville /ID# 278332
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JacksonvilleUnited StatesUnknown status
Redbird Research /ID# 279475
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Las VegasUnited StatesUnknown status
Ima Clinical Research Las Vegas /ID# 278054
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Las VegasUnited StatesUnknown status
Segal Trials - Lauderhill /ID# 273496
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LauderhillUnited StatesUnknown status
Synergy San Diego /ID# 278340
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Lemon GroveUnited StatesUnknown status
Alivation Research - Lincoln /ID# 279464
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LincolnUnited StatesUnknown status
Alliance for Research Alliance for Wellness /ID# 273477
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Long BeachUnited StatesUnknown status
Nrc Research Institute - Los Angeles /ID# 278450
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Los AngelesUnited StatesUnknown status
K2 Medical Research -Maitland /ID# 273487
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MaitlandUnited StatesUnknown status
GMI Florida - Central Miami Medical Institute (SMO/Network/Consortium) /ID# 273486
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MiamiUnited StatesUnknown status
Allied Biomedical Res Inst Inc /ID# 273476
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MiamiUnited StatesUnknown status
Floridian Clinical Research - Miami Lakes /ID# 279379
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Miami LakesUnited StatesUnknown status
Ima Clinical Research - Manhattan /ID# 278941
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New YorkUnited StatesUnknown status
Excell Research /ID# 273483
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OceansideUnited StatesUnknown status
Sooner Clinical Research /ID# 273491
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Oklahoma CityUnited StatesUnknown status
Apg Research /ID# 278439
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OrlandoUnited StatesUnknown status
Ima Clinical Research Phoenix /ID# 278047
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PhoenixUnited StatesUnknown status
Summit Research Network - Portland - Northwest Vaughn Street /ID# 278084
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PortlandUnited StatesUnknown status
Perceptive Pharma Research /ID# 273485
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RichmondUnited StatesUnknown status
Benchmark Research /ID# 273490
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ShreveportUnited StatesUnknown status
Voltaire - Springfield /ID# 278446
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SpringfieldUnited StatesUnknown status
Arch Clinical Trials /ID# 273481
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St LouisUnited StatesUnknown status
Inland Psychiatric Medical Group /ID# 273471
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TemeculaUnited StatesUnknown status
Family Psychiatry Of The Woodlands /ID# 278050
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The WoodlandsUnited StatesUnknown status
Bio Behavioral Health /ID# 273478
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Toms RiverUnited StatesUnknown status
Sunwise Clinical Research /ID# 278165
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Walnut CreekUnited StatesUnknown status
Health Synergy Clinical Research - West Palm Beach /ID# 279384
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West Palm BeachUnited StatesUnknown status

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