Study to Assess Adverse Events and Change in Disease Activity When Oral ABBV-932 is Added to Antidepressant Therapies in Adult Participants With Generalized Anxiety Disorder

Last updated: January 21, 2026
Sponsor: AbbVie
Overall Status: Active - Recruiting

Phase

2

Condition

Panic Disorders

Generalized Anxiety Disorder (Gad)

Anxiety Disorders

Treatment

ABBV-932

Antidepressant Therapy (ADT)

Placebo for ABBV-932

Clinical Study ID

NCT06846320
M25-099
  • Ages 18-65
  • All Genders

Study Summary

Generalized anxiety disorder (GAD) is usually treated with antidepressant therapy (ADT); however, sometimes ADTs alone are not enough to adequately treat GAD. The purpose of this study is to assess how safe and effective ABBV-932 is when added to the antidepressant therapies in adult participants with GAD who have had an inadequate response ADTs.

ABBV-932 is an investigational drug being developed for the adjunctive treatment of GAD. Participants will be randomly assigned to receive ABBV-932 or Placebo in addition to their currently prescribed ADTs. There is 1 in 3 chance of participants assigned to Placebo. Approximately 315 adult participants with GAD and inadequate response to ADTs will be enrolled in approximately 50 sites in the United States and Puerto Rico.

Participants will receive oral capsules of ABBV-932 or matching placebo in addition to their prescribed ADT for 6 weeks and then will be followed for an additional 4 week follow-up period.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular 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

Inclusion Criteria:

  • Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, TextRevision (DSM-5-TR) criteria for generalized anxiety disorder (GAD) confirmed by theMini International Neuropsychiatric Interview (MINI).

  • Currently taking one of the Food and Drug Administration (FDA) approvedantidepressant therapies (ADT) for GAD (i.e., escitalopram, paroxetine, duloxetine,or venlafaxine ER) with an inadequate response to an adequate dose (per label) andduration (>= 8 weeks) as verified by a baseline Hamilton Anxiety Rating Scale (HAM-A) total score >= 20 and Clinical Global Impression of Severity Scale (CGI-SGAD) >= 4.

Exclusion

Exclusion Criteria:

  • Have a Montgomery-Åsberg Depression Rating Scale (MADRS) score >= 20.

  • New diagnosis or exacerbation of major depression in the last 6 months.

Study Design

Total Participants: 315
Treatment Group(s): 3
Primary Treatment: ABBV-932
Phase: 2
Study Start date:
April 29, 2025
Estimated Completion Date:
November 30, 2026

Connect with a study center

  • BDH Research /ID# 267787

    San Juan, 00927
    Puerto Rico

    Site Not Available

  • INSPIRA Clinical Research /ID# 267822

    San Juan, 00918-3014
    Puerto Rico

    Active - Recruiting

  • BDH Research /ID# 267787

    San Juan 4568127, 00927
    Puerto Rico

    Active - Recruiting

  • INSPIRA Clinical Research /ID# 267822

    San Juan 4568127, 00918-3014
    Puerto Rico

    Active - Recruiting

  • Instituto De Neurologia Dra. Ivonne Fraga, Psc /ID# 267793

    San Juan 4568127, 00918
    Puerto Rico

    Active - Recruiting

  • University of Alabama - Huntsville Regional Medical Campus /ID# 267818

    Huntsville, Alabama 35801
    United States

    Site Not Available

  • University of Alabama - Huntsville Regional Medical Campus /ID# 267818

    Huntsville 4068590, Alabama 4829764 35801
    United States

    Active - Recruiting

  • Ima Clinical Research Phoenix (Alea) /ID# 275737

    Phoenix, Arizona 85012
    United States

    Site Not Available

  • Noble Clinical Research /ID# 267952

    Tucson, Arizona 85704
    United States

    Site Not Available

  • Ima Clinical Research Phoenix (Alea) /ID# 275737

    Phoenix 5308655, Arizona 5551752 85012
    United States

    Active - Recruiting

  • Noble Clinical Research /ID# 267952

    Tucson 5318313, Arizona 5551752 85704
    United States

    Completed

  • Advanced Research Center /ID# 267874

    Anaheim, California 92805
    United States

    Site Not Available

  • Axiom Research /ID# 267814

    Colton, California 92324
    United States

    Site Not Available

  • Sun Valley Research Center /ID# 267864

    Imperial, California 92251
    United States

    Site Not Available

  • Synergy San Diego /ID# 267879

    Lemon Grove, California 91945
    United States

    Site Not Available

  • Alliance for Research Alliance for Wellness /ID# 267911

    Long Beach, California 90807
    United States

    Site Not Available

  • NRC Research Institute DTLA /ID# 267832

    Los Angeles, California 90015
    United States

    Site Not Available

  • Excell Research /ID# 267918

    Oceanside, California 92056
    United States

    Site Not Available

  • Viking Clinical Research Center - Temecula /ID# 268598

    Temecula, California 92591
    United States

    Site Not Available

  • Sunwise Clinical Research /ID# 267863

    Walnut Creek, California 94596
    United States

    Site Not Available

  • Advanced Research Center /ID# 267874

    Anaheim 5323810, California 5332921 92805
    United States

    Active - Recruiting

  • Axiom Research /ID# 267814

    Colton 5338783, California 5332921 92324
    United States

    Active - Recruiting

  • Sun Valley Research Center /ID# 267864

    Imperial 5359052, California 5332921 92251
    United States

    Active - Recruiting

  • Synergy San Diego /ID# 267879

    Lemon Grove 5365893, California 5332921 91945
    United States

    Active - Recruiting

  • Alliance for Research Alliance for Wellness /ID# 267911

    Long Beach 5367929, California 5332921 90807
    United States

    Active - Recruiting

  • NRC Research Institute DTLA /ID# 267832

    Los Angeles 5368361, California 5332921 90015
    United States

    Active - Recruiting

  • Excell Research /ID# 267918

    Oceanside 5378771, California 5332921 92056
    United States

    Active - Recruiting

  • Viking Clinical Research Center - Temecula /ID# 268598

    Temecula 5401395, California 5332921 92591
    United States

    Active - Recruiting

  • Sunwise Clinical Research /ID# 267863

    Walnut Creek 5406990, California 5332921 94596
    United States

    Active - Recruiting

  • Connecticut Clinical Research - Cromwell /ID# 271241

    Cromwell, Connecticut 06416
    United States

    Site Not Available

  • Connecticut Clinical Research - Cromwell /ID# 271241

    Cromwell 4832121, Connecticut 4831725 06416
    United States

    Active - Recruiting

  • Cns Healthcare - Jacksonville /ID# 268588

    Jacksonville, Florida 32256
    United States

    Site Not Available

  • Accel Research Sites Network - St. Pete /ID# 267821

    Largo, Florida 33777
    United States

    Site Not Available

  • K2 Medical Research, LLC /ID# 267841

    Maitland, Florida 32751
    United States

    Site Not Available

  • Allied Biomedical Res Inst Inc /ID# 267813

    Miami, Florida 33155
    United States

    Active - Recruiting

  • GMI Florida - Central Miami Medical Institute /ID# 267839

    Miami, Florida 33125
    United States

    Site Not Available

  • Apg Research /ID# 271707

    Orlando, Florida 32803
    United States

    Site Not Available

  • Cns Healthcare - Jacksonville /ID# 268588

    Jacksonville 4160021, Florida 4155751 32256
    United States

    Active - Recruiting

  • Accel Research Sites Network - St. Pete /ID# 267821

    Largo 4161580, Florida 4155751 33777
    United States

    Active - Recruiting

  • K2 Medical Research, LLC /ID# 267841

    Maitland 4163220, Florida 4155751 32751
    United States

    Active - Recruiting

  • Allied Biomedical Res Inst Inc /ID# 267813

    Miami 4164138, Florida 4155751 33155
    United States

    Active - Recruiting

  • GMI Florida - Central Miami Medical Institute /ID# 267839

    Miami 4164138, Florida 4155751 33125
    United States

    Active - Recruiting

  • Apg Research /ID# 271707

    Orlando 4167147, Florida 4155751 32803
    United States

    Active - Recruiting

  • Psych Atlanta /ID# 267878

    Marietta, Georgia 30060
    United States

    Site Not Available

  • iResearch Savannah /ID# 267865

    Savannah, Georgia 31405
    United States

    Site Not Available

  • Psych Atlanta /ID# 267878

    Marietta 4207783, Georgia 4197000 30060
    United States

    Active - Recruiting

  • iResearch Savannah /ID# 267865

    Savannah 4221552, Georgia 4197000 31405
    United States

    Active - Recruiting

  • University of Chicago Medical Center /ID# 275131

    Chicago 4887398, Illinois 4896861 60637
    United States

    Active - Recruiting

  • Collective Medical Research /ID# 272015

    Overland Park, Kansas 66210
    United States

    Site Not Available

  • Collective Medical Research /ID# 272015

    Overland Park 4276873, Kansas 4273857 66210
    United States

    Active - Recruiting

  • CenExel /ID# 267853

    Gaithersburg, Maryland 20877-1407
    United States

    Site Not Available

  • CenExel /ID# 267853

    Gaithersburg 4355843, Maryland 4361885 20877-1407
    United States

    Active - Recruiting

  • Elixia, LLC /ID# 267815

    Springfield, Massachusetts 01103
    United States

    Site Not Available

  • Elixia, LLC /ID# 267815

    Springfield 4951788, Massachusetts 6254926 01103
    United States

    Active - Recruiting

  • Psychiatric Care And Research Center /ID# 271701

    O'Fallon, Missouri 63368
    United States

    Site Not Available

  • St. Charles Psychiatric Associates /ID# 271202

    Saint Charles, Missouri 63304
    United States

    Site Not Available

  • Arch Clinical Trials /ID# 267851

    Saint Louis, Missouri 63125
    United States

    Site Not Available

  • Psychiatric Care And Research Center /ID# 271701

    O'Fallon 4401242, Missouri 4398678 63368
    United States

    Active - Recruiting

  • St. Charles Psychiatric Associates /ID# 271202

    Saint Charles 4406831, Missouri 4398678 63304
    United States

    Active - Recruiting

  • Arch Clinical Trials /ID# 267851

    St Louis 4407066, Missouri 4398678 63125
    United States

    Active - Recruiting

  • Oasis Clinical Research, LLC /ID# 267953

    Las Vegas, Nevada 89121
    United States

    Site Not Available

  • Duplicate_Oasis Clinical Research, LLC /ID# 267953

    Las Vegas 5506956, Nevada 5509151 89121
    United States

    Completed

  • Ima Clinical Research Las Vegas (Altea) /ID# 275731

    Las Vegas 5506956, Nevada 5509151 89102
    United States

    Active - Recruiting

  • Oasis Clinical Research, LLC /ID# 267953

    Las Vegas 5506956, Nevada 5509151 89121
    United States

    Completed

  • Princeton Medical Institute /ID# 267877

    Princeton, New Jersey 08540
    United States

    Site Not Available

  • Bio Behavioral Health /ID# 267919

    Toms River, New Jersey 08755
    United States

    Site Not Available

  • Princeton Medical Institute /ID# 267877

    Princeton 5102922, New Jersey 5101760 08540
    United States

    Active - Recruiting

  • Bio Behavioral Health /ID# 267919

    Toms River 4504476, New Jersey 5101760 08755
    United States

    Active - Recruiting

  • Integrative Clinical Trials /ID# 279519

    Brooklyn 5110302, New York 5128638 11229
    United States

    Active - Recruiting

  • New Hope Clinical Research - Inpatient unit /ID# 267810

    Charlotte, North Carolina 28211
    United States

    Site Not Available

  • New Hope Clinical Research - Inpatient unit /ID# 267810

    Charlotte 4460243, North Carolina 4482348 28211
    United States

    Active - Recruiting

  • Quest Therapeutics of Avon /ID# 267829

    Avon Lake, Ohio 44012-1004
    United States

    Site Not Available

  • University Of Cincinnati Medical Center /ID# 271704

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • The Ohio State University /ID# 267924

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Quest Therapeutics of Avon /ID# 267829

    Avon Lake 5146286, Ohio 5165418 44012-1004
    United States

    Active - Recruiting

  • University Of Cincinnati Medical Center /ID# 271704

    Cincinnati 4508722, Ohio 5165418 45219
    United States

    Active - Recruiting

  • The Ohio State University /ID# 267924

    Columbus 4509177, Ohio 5165418 43210
    United States

    Active - Recruiting

  • Sooner Clinical Research /ID# 267881

    Oklahoma City, Oklahoma 73116
    United States

    Site Not Available

  • Sooner Clinical Research /ID# 267881

    Oklahoma City 4544349, Oklahoma 4544379 73116
    United States

    Active - Recruiting

  • Lehigh Center for Clinical Research /ID# 267908

    Allentown, Pennsylvania 18103
    United States

    Site Not Available

  • Suburban Research Associates /ID# 267868

    West Chester, Pennsylvania 19380-4370
    United States

    Site Not Available

  • Lehigh Center for Clinical Research /ID# 267908

    Allentown 5178127, Pennsylvania 6254927 18103
    United States

    Active - Recruiting

  • Suburban Research Associates /ID# 267868

    West Chester 4562144, Pennsylvania 6254927 19380-4370
    United States

    Active - Recruiting

  • Coastal Carolina Research Center, LLC /ID# 267826

    Charleston, South Carolina 29492
    United States

    Site Not Available

  • Coastal Carolina Research Center, LLC /ID# 267826

    Charleston 4574324, South Carolina 4597040 29492
    United States

    Active - Recruiting

  • Psychiatric Consultants - Franklin /ID# 275133

    Franklin, Tennessee 37067
    United States

    Site Not Available

  • Psychiatric Consultants - Franklin /ID# 275133

    Franklin 4623560, Tennessee 4662168 37067
    United States

    Active - Recruiting

  • Perceptive Pharma Research /ID# 267836

    Richmond, Texas 77407
    United States

    Site Not Available

  • Grayline Research Center /ID# 267811

    Wichita Falls, Texas 76309
    United States

    Site Not Available

  • FutureSearch Trials of Dallas /ID# 267870

    Dallas 4684888, Texas 4736286 75231
    United States

    Active - Recruiting

  • Relaro Medical Trials /ID# 270241

    Dallas 4684888, Texas 4736286 75243
    United States

    Active - Recruiting

  • Perceptive Pharma Research /ID# 267836

    Richmond 4722684, Texas 4736286 77407
    United States

    Active - Recruiting

  • Family Psychiatry Of The Woodlands /ID# 275173

    The Woodlands 4736476, Texas 4736286 77381
    United States

    Active - Recruiting

  • Grayline Research Center /ID# 267811

    Wichita Falls 4741752, Texas 4736286 76309
    United States

    Active - Recruiting

  • Northwest Clinical Research Center /ID# 267916

    Bellevue, Washington 98007
    United States

    Site Not Available

  • Core Clinical Research /ID# 270058

    Everett, Washington 98201
    United States

    Site Not Available

  • Northwest Clinical Research Center /ID# 267916

    Bellevue 5786882, Washington 5815135 98007
    United States

    Active - Recruiting

  • Core Clinical Research /ID# 270058

    Everett 5793933, Washington 5815135 98201
    United States

    Active - Recruiting

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