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

January 21, 2026 updated by: AbbVie

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dose Study to Evaluate the Efficacy, Safety, and Tolerability of ABBV-932 as an Adjunct to Antidepressant Therapies in the Treatment of Subjects With Generalized Anxiety Disorder Who Have Had an Inadequate Response to Antidepressant Therapies

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

315

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Puerto Rico
      • San Juan, Puerto Rico, 00918-3014
        • Recruiting
        • INSPIRA Clinical Research /ID# 267822
      • San Juan, Puerto Rico, 00927
        • Recruiting
        • BDH Research /ID# 267787
        • Contact:
          • Site Coordinator
          • Phone Number: 787-523-9808
      • San Juan, Puerto Rico, 00918
        • Recruiting
        • Instituto De Neurologia Dra. Ivonne Fraga, Psc /ID# 267793
        • Contact:
          • Site Coordinator
          • Phone Number: 787-763-9312
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Recruiting
        • University of Alabama - Huntsville Regional Medical Campus /ID# 267818
        • Contact:
          • Site Coordinator
          • Phone Number: 256-551-4431
    • Arizona
      • Phoenix, Arizona, United States, 85012
        • Recruiting
        • Ima Clinical Research Phoenix (Alea) /ID# 275737
      • Tucson, Arizona, United States, 85704
        • Completed
        • Noble Clinical Research /ID# 267952
    • California
      • Anaheim, California, United States, 92805
        • Recruiting
        • Advanced Research Center /ID# 267874
        • Contact:
          • Site Coordinator
          • Phone Number: 714-999-6688
      • Colton, California, United States, 92324
        • Recruiting
        • Axiom Research /ID# 267814
        • Contact:
          • Site Coordinator
          • Phone Number: 909-824-2325
      • Imperial, California, United States, 92251
        • Recruiting
        • Sun Valley Research Center /ID# 267864
        • Contact:
          • Site Coordinator
          • Phone Number: 760-545-0123
      • Lemon Grove, California, United States, 91945
        • Recruiting
        • Synergy San Diego /ID# 267879
      • Long Beach, California, United States, 90807
        • Recruiting
        • Alliance for Research Alliance for Wellness /ID# 267911
      • Los Angeles, California, United States, 90015
        • Recruiting
        • NRC Research Institute DTLA /ID# 267832
        • Contact:
          • Site Coordinator
          • Phone Number: 714-289-1100
      • Oceanside, California, United States, 92056
        • Recruiting
        • Excell Research /ID# 267918
      • Temecula, California, United States, 92591
        • Recruiting
        • Viking Clinical Research Center - Temecula /ID# 268598
      • Walnut Creek, California, United States, 94596
        • Recruiting
        • Sunwise Clinical Research /ID# 267863
        • Contact:
          • Site Coordinator
          • Phone Number: 925-298-5147
    • Connecticut
      • Cromwell, Connecticut, United States, 06416
        • Recruiting
        • Connecticut Clinical Research - Cromwell /ID# 271241
    • Florida
      • Jacksonville, Florida, United States, 32256
        • Recruiting
        • Cns Healthcare - Jacksonville /ID# 268588
      • Largo, Florida, United States, 33777
        • Recruiting
        • Accel Research Sites Network - St. Pete /ID# 267821
        • Contact:
          • Site Coordinator
          • Phone Number: 321-878-9477
      • Maitland, Florida, United States, 32751
        • Recruiting
        • K2 Medical Research, LLC /ID# 267841
      • Miami, Florida, United States, 33155
        • Recruiting
        • Allied Biomedical Res Inst Inc /ID# 267813
        • Contact:
          • Site Coordinator
          • Phone Number: 305-643-8400
      • Miami, Florida, United States, 33125
        • Recruiting
        • GMI Florida - Central Miami Medical Institute /ID# 267839
        • Contact:
          • Site Coordinator
          • Phone Number: 305-547-2011
      • Orlando, Florida, United States, 32803
        • Recruiting
        • Apg Research /ID# 271707
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Recruiting
        • Psych Atlanta /ID# 267878
      • Savannah, Georgia, United States, 31405
        • Recruiting
        • iResearch Savannah /ID# 267865
        • Contact:
          • Site Coordinator
          • Phone Number: 912-744-0800
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • University of Chicago Medical Center /ID# 275131
    • Kansas
      • Overland Park, Kansas, United States, 66210
        • Recruiting
        • Collective Medical Research /ID# 272015
    • Maryland
      • Gaithersburg, Maryland, United States, 20877-1407
        • Recruiting
        • CenExel /ID# 267853
        • Contact:
          • Site Coordinator
          • Phone Number: 301-251-4702
    • Massachusetts
      • Springfield, Massachusetts, United States, 01103
        • Recruiting
        • Elixia, LLC /ID# 267815
        • Contact:
          • Site Coordinator
          • Phone Number: 413-305-1144
    • Missouri
      • O'Fallon, Missouri, United States, 63368
        • Recruiting
        • Psychiatric Care And Research Center /ID# 271701
      • Saint Charles, Missouri, United States, 63304
        • Recruiting
        • St. Charles Psychiatric Associates /ID# 271202
      • St Louis, Missouri, United States, 63125
        • Recruiting
        • Arch Clinical Trials /ID# 267851
    • Nevada
      • Las Vegas, Nevada, United States, 89121
        • Completed
        • Duplicate_Oasis Clinical Research, LLC /ID# 267953
      • Las Vegas, Nevada, United States, 89102
        • Recruiting
        • Ima Clinical Research Las Vegas (Altea) /ID# 275731
    • New Jersey
      • Princeton, New Jersey, United States, 08540
        • Recruiting
        • Princeton Medical Institute /ID# 267877
        • Contact:
          • Site Coordinator
          • Phone Number: 609-921-3555
      • Toms River, New Jersey, United States, 08755
        • Recruiting
        • Bio Behavioral Health /ID# 267919
    • New York
      • Brooklyn, New York, United States, 11229
        • Recruiting
        • Integrative Clinical Trials /ID# 279519
    • North Carolina
      • Charlotte, North Carolina, United States, 28211
        • Recruiting
        • New Hope Clinical Research - Inpatient unit /ID# 267810
        • Contact:
          • Site Coordinator
          • Phone Number: 980-209-9784
    • Ohio
      • Avon Lake, Ohio, United States, 44012-1004
        • Recruiting
        • Quest Therapeutics of Avon /ID# 267829
        • Contact:
          • Site Coordinator
          • Phone Number: 440-949-9115
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • University Of Cincinnati Medical Center /ID# 271704
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • The Ohio State University /ID# 267924
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73116
        • Recruiting
        • Sooner Clinical Research /ID# 267881
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Recruiting
        • Lehigh Center for Clinical Research /ID# 267908
      • West Chester, Pennsylvania, United States, 19380-4370
        • Recruiting
        • Suburban Research Associates /ID# 267868
        • Contact:
          • Site Coordinator
          • Phone Number: 610-891-7200
    • South Carolina
      • Charleston, South Carolina, United States, 29492
        • Recruiting
        • Coastal Carolina Research Center, LLC /ID# 267826
        • Contact:
          • Site Coordinator
          • Phone Number: 321-878-9477
    • Tennessee
      • Franklin, Tennessee, United States, 37067
        • Recruiting
        • Psychiatric Consultants - Franklin /ID# 275133
        • Contact:
          • Site Coordinator
          • Phone Number: 615-807-4023
    • Texas
      • Dallas, Texas, United States, 75243
        • Recruiting
        • Relaro Medical Trials /ID# 270241
      • Dallas, Texas, United States, 75231
        • Recruiting
        • FutureSearch Trials of Dallas /ID# 267870
      • Richmond, Texas, United States, 77407
        • Recruiting
        • Perceptive Pharma Research /ID# 267836
        • Contact:
          • Site Coordinator
          • Phone Number: 346-467-2182
      • The Woodlands, Texas, United States, 77381
        • Recruiting
        • Family Psychiatry Of The Woodlands /ID# 275173
      • Wichita Falls, Texas, United States, 76309
        • Recruiting
        • Grayline Research Center /ID# 267811
        • Contact:
          • Site Coordinator
          • Phone Number: 940-322-1131
    • Washington
      • Bellevue, Washington, United States, 98007
        • Recruiting
        • Northwest Clinical Research Center /ID# 267916
      • Everett, Washington, United States, 98201
        • Recruiting
        • Core Clinical Research /ID# 270058

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 one of the Food and Drug Administration (FDA) approved antidepressant therapies (ADT) for GAD (i.e., escitalopram, paroxetine, duloxetine, or venlafaxine ER) 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ABBV-932 Dose A
Participants will receive ABBV-932 dose A in addition to prescribed antidepressant therapies (ADTs).
Drug: ABBV-932
Oral Capsule
Drug: Antidepressant Therapy (ADT)
Standard of care
Experimental: ABBV-932 Dose B
Participants will receive ABBV-932 dose B in addition to prescribed antidepressant therapies (ADTs).
Drug: ABBV-932
Oral Capsule
Drug: Antidepressant Therapy (ADT)
Standard of care
Placebo Comparator: Placebo for ABBV-932
Participants will receive placebo for ABBV-932 in addition to prescribed antidepressant therapies (ADTs).
Drug: Placebo for ABBV-932
Oral Capsule
Drug: Antidepressant Therapy (ADT)
Standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Adverse Events (AEs)
Time Frame: Up to approximately 10 weeks
An AE is defined as any untoward medical occurrence in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Up to approximately 10 weeks
Change from Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score
Time Frame: Up to approximately 6 weeks
The HAM-A is a 14-item, clinician-reported measure used to quantify and categorize the participant's anxiety over the past week. Items are rated on a 5-point Likert rating scale. The HAM-A total score ranges from 0 to 56, with higher scores indicating greater anxiety severity.
Up to approximately 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Penn State Worry Questionnaire-10 (PSWQ-10) Total Score
Time Frame: Up to approximately 6 weeks
The PSWQ-10 is a 10-item, participant-reported measure of the tendency of an individual to worry, the excessiveness or intensity of worry, and the tendency for the worry to be generalized and not restricted to a small number of situations. Items are rated from 0 to 6 (0, never; 6, almost always). Total scores range from 0 to 60, with higher scores indicating greater worry.
Up to approximately 6 weeks
Change from Baseline in Clinical Global Impression of Severity Scale (CGI-S) Generalized Anxiety Disorder (GAD)
Time Frame: Up to approximately 6 weeks
The CGI-S GAD is a single, clinician-reported item that measures the clinician's impression of a participant's current anxiety severity considering their total clinical experience with the participant population. The measure uses a 5-point Likert rating scale, with higher scores indicating greater anxiety severity.
Up to approximately 6 weeks
Change from Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score
Time Frame: Up to approximately 4 weeks
The HAM-A is a 14-item, clinician-reported measure used to quantify and categorize the participant's anxiety over the past week. Items are rated on a 5-point Likert rating scale. The HAM-A total score ranges from 0 to 56, with higher scores indicating greater anxiety severity.
Up to approximately 4 weeks
Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
Time Frame: Up to approximately 6 weeks
The MADRS is a 10-item, clinician-rated scale that evaluates the participant's depressive symptomatology during the past week. Participants are rated on items assessing feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty in concentration, and lack of interest. Each item is scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity.
Up to approximately 6 weeks
Percentage of Participants in Remission
Time Frame: Up to approximately 6 weeks
Remission is defined as HAM-A total score <=7.
Up to approximately 6 weeks
Percentage of Participants with HAM-A Response
Time Frame: Up to approximately 6 weeks
HAM-A response is defined as >= 50% reduction from baseline in HAM-A total score
Up to approximately 6 weeks
Percentage of Participants with Clinical Global Impression of Change (CGI-C) GAD Responder Status of "Much Better" or "Moderately Better"
Time Frame: Up to approximately 6 weeks
The CGI-C GAD is a clinician-rated scale that measures the overall change in a participant's GAD symptoms since initial receipt of the study medication. The participant is rated on a 7-point Likert scale ranging from "Much better" (1) to "Much worse" (7).
Up to approximately 6 weeks
Change from Baseline in Patient Global Impression of Severity Scale (PGI-S) Generalized Anxiety Disorder (GAD)
Time Frame: Up to approximately 6 weeks
The PGI-S GAD is a single, patient-reported item that assesses the subject's perceived level of GAD symptoms over the past 7 days. The measure uses a 5-point Likert rating scale with responses ranging from "no symptoms" (1) to "very severe" (5), with higher scores indicating greater severity of GAD symptoms.
Up to approximately 6 weeks
Percentage of Participants with Patient Global Impression of Change Scale (PGI-C) Generalized Anxiety Disorder (GAD) Responder Status of "Much Better" or "Moderately Better"
Time Frame: Up to approximately 6 weeks
The PGI-C GAD is a single, patient-reported item that assesses the subject's perceived overall change in their GAD symptoms since they started taking the study medication. The measure uses a 7-point Likert rating scale with responses ranging from "much better" (1) to "much worse" (7). Higher scores indicate worse GAD symptoms
Up to approximately 6 weeks
Change from Baseline in Patient Global Impression of Severity Scale (PGI-S) Worry
Time Frame: Up to approximately 6 weeks
The PGI-C Worry is a single, patient-reported item that assesses the subject's perceived overall change in their worry since they started taking the study medication. The measure uses a 7-point Likert rating scale with responses ranging from "much less worried" (1) to "much more worried" (7). Higher scores indicate more worry.
Up to approximately 6 weeks
Percentage of Participants with Patient Global Impression of Change Scale (PGI-C) Worry Responder Status of "Much Better" or "Moderately Better"
Time Frame: Up to approximately 6 weeks
The PGI-C Worry is a single, patient-reported item that assesses the subject's perceived overall change in their worry since they started taking the study medication. The measure uses a 7-point Likert rating scale with responses ranging from "much less worried" (1) to "much more worried" (7). Higher scores indicate more worry.
Up to approximately 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 29, 2025

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

February 21, 2025

First Submitted That Met QC Criteria

February 21, 2025

First Posted (Actual)

February 26, 2025

Study Record Updates

Last Update Posted (Actual)

January 23, 2026

Last Update Submitted That Met QC Criteria

January 21, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M25-099

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

IPD Sharing Time Frame

For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/

IPD Sharing Access Criteria

To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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