Recruiting

Phase 2

ABBV-932 with AntidepressantsStudy 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

Sponsor:

AbbVie

Code:

NCT06846320

Conditions

Generalized Anxiety Disorder (GAD)

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

ABBV-932

Placebo for ABBV-932

Antidepressant Therapy (ADT)

Study Details

Brief 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.

Conditions

Generalized Anxiety Disorder (GAD)

Study ID

NCT06846320

Start date

Apr 29, 2025

Status verified date

Jun, 2026

Completion date

Nov, 2026

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

315 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ABBV-932 Dose A

Participants will receive ABBV-932 dose A in addition to prescribed antidepressant therapies (ADTs).

experimental: ABBV-932 Dose B

Participants will receive ABBV-932 dose B in addition to prescribed antidepressant therapies (ADTs).

placebo comparator: Placebo for ABBV-932

Participants will receive placebo for ABBV-932 in addition to prescribed antidepressant therapies (ADTs).

Interventions

ABBV-932

Oral Capsule

Placebo for ABBV-932

Oral Capsule

Antidepressant Therapy (ADT)

Standard of care

Primary outcome measure

Number of Participants with Adverse Events (AEs) [ Time Frame: Up to approximately 10 weeks ]
Change from Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score [ Time Frame: Up to approximately 6 weeks ]

Central Contacts and Locations

Central contacts

ABBVIE CALL CENTER

844-663-3742 abbvieclinicaltrials@abbvie.com

Locations

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

Recruiting

Huntsville, Alabama, United States, 35801

Contacts

Site Coordinator

256-551-4431

Ima Clinical Research Phoenix (Alea) /ID# 275737

Recruiting

Phoenix, Arizona, United States, 85012

Advanced Research Center /ID# 267874

Recruiting

Anaheim, California, United States, 92805

Contacts

Site Coordinator

714-999-6688

Axiom Research /ID# 267814

Recruiting

Colton, California, United States, 92324

Contacts

Site Coordinator

909-824-2325

Sun Valley Research Center /ID# 267864

Recruiting

Imperial, California, United States, 92251

Contacts

Site Coordinator

760-545-0123

Synergy San Diego /ID# 267879

Recruiting

Lemon Grove, California, United States, 91945

Alliance for Research Alliance for Wellness /ID# 267911

Recruiting

Long Beach, California, United States, 90807

NRC Research Institute DTLA /ID# 267832

Recruiting

Los Angeles, California, United States, 90015

Contacts

Site Coordinator

714-289-1100

Excell Research /ID# 267918

Recruiting

Oceanside, California, United States, 92056

Inland Psychiatric Medical Group /ID# 268598

Recruiting

Temecula, California, United States, 92591

Sunwise Clinical Research /ID# 267863

Recruiting

Walnut Creek, California, United States, 94596

Contacts

Site Coordinator

925-298-5147

Connecticut Clinical Research - Cromwell /ID# 271241

Recruiting

Cromwell, Connecticut, United States, 06416

Cns Healthcare - Jacksonville /ID# 268588

Recruiting

Jacksonville, Florida, United States, 32256

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

Recruiting

Largo, Florida, United States, 33777

Contacts

Site Coordinator

321-878-9477

K2 Medical Research, LLC /ID# 267841

Recruiting

Maitland, Florida, United States, 32751

GMI Florida - Central Miami Medical Institute /ID# 267839

Recruiting

Miami, Florida, United States, 33125

Contacts

Site Coordinator

305-547-2011

Allied Biomedical Res Inst Inc /ID# 267813

Recruiting

Miami, Florida, United States, 33155

Contacts

Site Coordinator

305-643-8400

Apg Research /ID# 271707

Recruiting

Orlando, Florida, United States, 32803

Psych Atlanta /ID# 267878

Recruiting

Marietta, Georgia, United States, 30060

iResearch Savannah /ID# 267865

Recruiting

Savannah, Georgia, United States, 31405

Contacts

Site Coordinator

912-744-0800

University of Chicago Medical Center /ID# 275131

Recruiting

Chicago, Illinois, United States, 60637

Collective Medical Research /ID# 272015

Recruiting

Overland Park, Kansas, United States, 66210

CenExel /ID# 267853

Recruiting

Gaithersburg, Maryland, United States, 20877-1407

Contacts

Site Coordinator

301-251-4702

Elixia - Springfield /ID# 267815

Recruiting

Springfield, Massachusetts, United States, 01103

Psychiatric Care And Research Center /ID# 271701

Recruiting

O'Fallon, Missouri, United States, 63368

Saint Charles Psychiatric Associates /ID# 271202

Recruiting

Saint Charles, Missouri, United States, 63304

Arch Clinical Trials /ID# 267851

Recruiting

St Louis, Missouri, United States, 63125

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

Recruiting

Las Vegas, Nevada, United States, 89102

Princeton Medical Institute /ID# 267877

Recruiting

Princeton, New Jersey, United States, 08540

Contacts

Site Coordinator

609-921-3555

Bio Behavioral Health /ID# 267919

Recruiting

Toms River, New Jersey, United States, 08755

Integrative Clinical Trials /ID# 279519

Recruiting

Brooklyn, New York, United States, 11229

New Hope Clinical Research - Inpatient unit /ID# 267810

Recruiting

Charlotte, North Carolina, United States, 28211

Contacts

Site Coordinator

980-209-9784

Quest Therapeutics of Avon /ID# 267829

Recruiting

Avon Lake, Ohio, United States, 44012-1004

Contacts

Site Coordinator

440-949-9115

University Of Cincinnati Medical Center /ID# 271704

Recruiting

Cincinnati, Ohio, United States, 45219

The Ohio State University /ID# 267924

Recruiting

Columbus, Ohio, United States, 43210

Sooner Clinical Research /ID# 267881

Recruiting

Oklahoma City, Oklahoma, United States, 73116

Lehigh Center for Clinical Research /ID# 267908

Recruiting

Allentown, Pennsylvania, United States, 18103

Suburban Research Associates /ID# 267868

Recruiting

West Chester, Pennsylvania, United States, 19380-4370

Contacts

Site Coordinator

610-891-7200

Coastal Carolina Research Center, LLC /ID# 267826

Recruiting

Charleston, South Carolina, United States, 29492

Contacts

Site Coordinator

321-878-9477

Psychiatric Consultants - Franklin /ID# 275133

Recruiting

Franklin, Tennessee, United States, 37067

Contacts

Site Coordinator

615-807-4023

FutureSearch Trials of Dallas /ID# 267870

Recruiting

Dallas, Texas, United States, 75231

Relaro Medical Trials /ID# 270241

Recruiting

Dallas, Texas, United States, 75243

Perceptive Pharma Research /ID# 267836

Recruiting

Richmond, Texas, United States, 77407

Contacts

Site Coordinator

346-467-2182

Family Psychiatry Of The Woodlands /ID# 275173

Recruiting

The Woodlands, Texas, United States, 77381

Grayline Research Center /ID# 267811

Recruiting

Wichita Falls, Texas, United States, 76309

Contacts

Site Coordinator

940-322-1131

Northwest Clinical Research Center /ID# 267916

Recruiting

Bellevue, Washington, United States, 98007

Core Clinical Research /ID# 270058

Recruiting

Everett, Washington, United States, 98201

More Information

Sponsor

AbbVie

Last update posted

Jun 17, 2026

Last verified

Jun, 2026

Keywords

LEGATO - (GAD)
Generalized Anxiety Disorder (GAD)
ABBV-932

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-19. This information was provided to ClinicalTrials.gov by AbbVie on 2026-06-17.