Actively Recruiting

Phase 2
Age: 18Years - 65Years
All Genders
NCT07220460

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

Led by AbbVie · Updated on 2026-04-07

200

Participants Needed

49

Research Sites

78 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Body Mass Index (BMI) between 18.0 and 40.0 kg/m2, inclusive
  • Diagnosis of bipolar I or II disorder without psychotic features, currently experiencing a depressive episode lasting at least 4 weeks but not more than 12 months
  • Normal or clinically insignificant abnormal physical exam, laboratory tests, vital signs, and 12-lead ECG at screening
  • No psychiatric hospitalization in the past 3 months
  • No lifetime history of schizophrenia, psychotic disorders, dissociative disorders, or neurocognitive disorders
  • No moderate or severe substance use disorder (except nicotine) in the past 6 months
Not Eligible

You will not qualify if you...

  • Young Mania Rating Scale (YMRS) score greater than 12 at baseline
  • History of allergic reaction or significant sensitivity to ABBV-932 or similar products
  • Any concurrent medical condition that could interfere with the study, affect results, or pose risk, including unstable conditions or history of malignancy (except treated basal or squamous cell carcinoma)
  • Significant hematologic, endocrine, cardiovascular, respiratory, renal (eGFR < 30 mL/min), hepatic (including severe impairment), gastrointestinal, or neurological disorders unless stable for over 1 year and not requiring prohibited medications

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 49 locations

1

Ima Clinical Research Phoenix (Alea) /ID# 278047

Phoenix, Arizona, United States, 85012

Actively Recruiting

2

Advanced Research Center /ID# 273474

Anaheim, California, United States, 92805

Actively Recruiting

3

Axiom Research /ID# 273482

Colton, California, United States, 92324

Actively Recruiting

4

Collaborative Neuroscience Research - Garden Grove /ID# 273492

Garden Grove, California, United States, 92845

Actively Recruiting

5

Sun Valley Research Center /ID# 273472

Imperial, California, United States, 92251

Actively Recruiting

6

Synergy San Diego /ID# 278340

Lemon Grove, California, United States, 91945

Actively Recruiting

7

Alliance for Research Alliance for Wellness /ID# 273477

Long Beach, California, United States, 90807

Actively Recruiting

8

Nrc Research Institute - Los Angeles /ID# 278450

Los Angeles, California, United States, 90015

Actively Recruiting

9

Excell Research /ID# 273483

Oceanside, California, United States, 92056

Actively Recruiting

10

Inland Psychiatric Medical Group Inc. /ID# 273471

Temecula, California, United States, 92591

Actively Recruiting

11

Sunwise Clinical Research /ID# 278165

Walnut Creek, California, United States, 94596

Actively Recruiting

12

Connecticut Clinical Research - Cromwell /ID# 278116

Cromwell, Connecticut, United States, 06416

Actively Recruiting

13

Cns Healthcare - Jacksonville /ID# 278332

Jacksonville, Florida, United States, 32256

Actively Recruiting

14

GMI Florida - Central Miami Medical Institute /ID# 273486

Miami, Florida, United States, 33125

Actively Recruiting

15

Allied Biomedical Res Inst Inc /ID# 273476

Miami, Florida, United States, 33155

Actively Recruiting

16

Floridian Clinical Research - Miami Lakes /ID# 279379

Miami Lakes, Florida, United States, 33016

Actively Recruiting

17

K2 Medical Research - Orlando - South Orlando Avenue /ID# 273487

Orlando, Florida, United States, 32751

Actively Recruiting

18

Apg Research /ID# 278439

Orlando, Florida, United States, 32803

Actively Recruiting

19

Segal Trials - West Broward Outpatient Research Site /ID# 273496

Tamarac, Florida, United States, 33319-4985

Actively Recruiting

20

Health Synergy Clinical Research /ID# 279384

West Palm Beach, Florida, United States, 33407

Actively Recruiting

21

Trialmed /ID# 278046

Atlanta, Georgia, United States, 30328

Actively Recruiting

22

Atlanta Center for Medical Research /ID# 278827

Atlanta, Georgia, United States, 30331

Actively Recruiting

23

Revive Research Institute - Elgin /ID# 279756

Elgin, Illinois, United States, 60123

Actively Recruiting

24

Benchmark Research /ID# 273490

Shreveport, Louisiana, United States, 71101

Completed

25

Pharmasite Research, Inc. /ID# 279163

Baltimore, Maryland, United States, 21208

Actively Recruiting

26

Elixia, LLC /ID# 278446

Springfield, Massachusetts, United States, 01103

Actively Recruiting

27

MSB Neuroscience /ID# 278168

Jackson, Mississippi, United States, 39216-4643

Actively Recruiting

28

Arch Clinical Trials /ID# 273481

St Louis, Missouri, United States, 63125

Actively Recruiting

29

Alivation Research /ID# 279464

Lincoln, Nebraska, United States, 68526

Actively Recruiting

30

Ima Clinical Research Las Vegas (Altea) /ID# 278054

Las Vegas, Nevada, United States, 89102

Actively Recruiting

31

Redbird Research /ID# 279475

Las Vegas, Nevada, United States, 89119

Actively Recruiting

32

Bio Behavioral Health /ID# 273478

Toms River, New Jersey, United States, 08755

Actively Recruiting

33

Integrative Clinical Trials /ID# 278040

Brooklyn, New York, United States, 11229

Actively Recruiting

34

Neurobehavioral Research /ID# 273470

Cedarhurst, New York, United States, 11516

Actively Recruiting

35

Ima Clinical Research - Manhattan /ID# 278941

New York, New York, United States, 10036

Actively Recruiting

36

New Hope Clinical Research - Inpatient unit /ID# 273468

Charlotte, North Carolina, United States, 28211

Actively Recruiting

37

Quest Therapeutics of Avon Lake /ID# 273484

Avon Lake, Ohio, United States, 44012

Actively Recruiting

38

OSU Psychiatry Department /ID# 273495

Columbus, Ohio, United States, 43210

Actively Recruiting

39

Sooner Clinical Research /ID# 273491

Oklahoma City, Oklahoma, United States, 73116

Actively Recruiting

40

Summit Research Network - Portland - Northwest Vaughn Street /ID# 278084

Portland, Oregon, United States, 97210

Actively Recruiting

41

Lehigh Center for Clinical Research /ID# 273466

Allentown, Pennsylvania, United States, 18103

Actively Recruiting

42

FutureSearch Trials of Dallas /ID# 273473

Dallas, Texas, United States, 75231

Actively Recruiting

43

Epic Medical Research - DeSoto /ID# 278045

DeSoto, Texas, United States, 75115

Actively Recruiting

44

Perceptive Pharma Research /ID# 273485

Richmond, Texas, United States, 77407

Actively Recruiting

45

Family Psychiatry Of The Woodlands /ID# 278050

The Woodlands, Texas, United States, 77381

Actively Recruiting

46

Northwest Clinical Research Center /ID# 273480

Bellevue, Washington, United States, 98007

Actively Recruiting

47

Core Clinical Research /ID# 273498

Everett, Washington, United States, 98201

Actively Recruiting

48

INSPIRA Clinical Research /ID# 274670

San Juan, Puerto Rico, 00918-3014

Actively Recruiting

49

BDH Research /ID# 274677

San Juan, Puerto Rico, 00927

Actively Recruiting

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Research Team

A

ABBVIE CALL CENTER

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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