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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

AbbVie

Start Date

4/29/2025

Completion Date

11/1/2026

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

Age Range: 18 years to 65 years

Inclusion Criteria: * Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria for generalized anxiety disorder (GAD) confirmed by the Mini International Neuropsychiatric Interview (MINI). * Currently taking protocol-specified antidepressant therapies (ADT) for GAD with an inadequate response to an adequate dose (per label) and duration (\>= 8 weeks) as verified by a baseline Hamilton Anxiety Rating Scale (HAM-A) total score \>= 20 and Clinical Global Impression of Severity Scale (CGI-S GAD) \>= 4. Exclusion Criteria: * Have a Montgomery-Åsberg Depression Rating Scale (MADRS) score \>= 20. * New diagnosis or exacerbation of major depression in the last 6 months.

Interventions

DRUG

ABBV-932

DRUG

Placebo for ABBV-932

DRUG

Antidepressant Therapy (ADT)

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Conditions

Generalized Anxiety Disorder (GAD)

Locations

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

Huntsville, Alabama 35801

United States

Ima Clinical Research Phoenix (Alea) /ID# 275737

Phoenix, Arizona 85012

United States

Noble Clinical Research /ID# 267952

Tucson, Arizona 85704

United States

Advanced Research Center /ID# 267874

Anaheim, California 92805

United States

Axiom Research /ID# 267814

Colton, California 92324

United States

Sun Valley Research Center /ID# 267864

Imperial, California 92251

United States

Synergy San Diego /ID# 267879

Lemon Grove, California 91945

United States

Alliance for Research Alliance for Wellness /ID# 267911

Long Beach, California 90807

United States

NRC Research Institute DTLA /ID# 267832

Los Angeles, California 90015

United States

Excell Research /ID# 267918

Oceanside, California 92056

United States

Inland Psychiatric Medical Group /ID# 268598

Temecula, California 92591

United States

Sunwise Clinical Research /ID# 267863

Walnut Creek, California 94596

United States

Connecticut Clinical Research - Cromwell /ID# 271241

Cromwell, Connecticut 06416

United States

Cns Healthcare - Jacksonville /ID# 268588

Jacksonville, Florida 32256

United States

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

Largo, Florida 33777

United States

K2 Medical Research, LLC /ID# 267841

Maitland, Florida 32751

United States

GMI Florida - Central Miami Medical Institute /ID# 267839

Miami, Florida 33125

United States

Allied Biomedical Res Inst Inc /ID# 267813

Miami, Florida 33155

United States

Apg Research /ID# 271707

Orlando, Florida 32803

United States

Psych Atlanta /ID# 267878

Marietta, Georgia 30060

United States

iResearch Savannah /ID# 267865

Savannah, Georgia 31405

United States

University of Chicago Medical Center /ID# 275131

Chicago, Illinois 60637

United States

Collective Medical Research /ID# 272015

Overland Park, Kansas 66210

United States

CenExel /ID# 267853

Gaithersburg, Maryland 20877-1407

United States

Elixia - Springfield /ID# 267815

Springfield, Massachusetts 01103

United States

Psychiatric Care And Research Center /ID# 271701

O'Fallon, Missouri 63368

United States

Saint Charles Psychiatric Associates /ID# 271202

Saint Charles, Missouri 63304

United States

Arch Clinical Trials /ID# 267851

St Louis, Missouri 63125

United States

Ima Clinical Research Las Vegas (SMO/Network/Consortium) /ID# 275731

Las Vegas, Nevada 89102

United States

Duplicate_Oasis Clinical Research, LLC /ID# 267953

Las Vegas, Nevada 89121

United States

Princeton Medical Institute /ID# 267877

Princeton, New Jersey 08540

United States

Bio Behavioral Health /ID# 267919

Toms River, New Jersey 08755

United States

Integrative Clinical Trials /ID# 279519

Brooklyn, New York 11229

United States

New Hope Clinical Research - Inpatient unit /ID# 267810

Charlotte, North Carolina 28211

United States

Quest Therapeutics of Avon /ID# 267829

Avon Lake, Ohio 44012-1004

United States

University Of Cincinnati Medical Center /ID# 271704

Cincinnati, Ohio 45219

United States

The Ohio State University /ID# 267924

Columbus, Ohio 43210

United States

Sooner Clinical Research /ID# 267881

Oklahoma City, Oklahoma 73116

United States

Lehigh Center for Clinical Research /ID# 267908

Allentown, Pennsylvania 18103

United States

Suburban Research Associates /ID# 267868

West Chester, Pennsylvania 19380-4370

United States

Coastal Carolina Research Center, LLC /ID# 267826

Charleston, South Carolina 29492

United States

Psychiatric Consultants - Franklin /ID# 275133

Franklin, Tennessee 37067

United States

FutureSearch Trials of Dallas /ID# 267870

Dallas, Texas 75231

United States

Relaro Medical Trials /ID# 270241

Dallas, Texas 75243

United States

Perceptive Pharma Research /ID# 267836

Richmond, Texas 77407

United States

Family Psychiatry Of The Woodlands /ID# 275173

The Woodlands, Texas 77381

United States

Grayline Research Center /ID# 267811

Wichita Falls, Texas 76309

United States

Northwest Clinical Research Center /ID# 267916

Bellevue, Washington 98007

United States

Core Clinical Research /ID# 270058

Everett, Washington 98201

United States

Inspira Clinical Research /ID# 267822

San Juan, 00918-3014

Puerto Rico

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

San Juan, 00918

Puerto Rico

BDH Research /ID# 267787

San Juan, 00927

Puerto Rico