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
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
1 other identifier
interventional
315
2 countries
52
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2025
Shorter than P25 for phase_2
52 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 21, 2025
CompletedFirst Posted
Study publicly available on registry
February 26, 2025
CompletedStudy Start
First participant enrolled
April 29, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2026
January 23, 2026
January 1, 2026
1.5 years
February 21, 2025
January 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Participants with Adverse Events (AEs)
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
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 Outcomes (11)
Change from Baseline in Penn State Worry Questionnaire-10 (PSWQ-10) Total Score
Up to approximately 6 weeks
Change from Baseline in Clinical Global Impression of Severity Scale (CGI-S) Generalized Anxiety Disorder (GAD)
Up to approximately 6 weeks
Change from Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score
Up to approximately 4 weeks
Change From Baseline in Montgomery-Ã…sberg Depression Rating Scale (MADRS) Total Score
Up to approximately 6 weeks
Percentage of Participants in Remission
Up to approximately 6 weeks
- +6 more secondary outcomes
Study Arms (3)
ABBV-932 Dose A
EXPERIMENTALParticipants will receive ABBV-932 dose A in addition to prescribed antidepressant therapies (ADTs).
ABBV-932 Dose B
EXPERIMENTALParticipants will receive ABBV-932 dose B in addition to prescribed antidepressant therapies (ADTs).
Placebo for ABBV-932
PLACEBO COMPARATORParticipants will receive placebo for ABBV-932 in addition to prescribed antidepressant therapies (ADTs).
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Have a Montgomery-Ã…sberg Depression Rating Scale (MADRS) score \>= 20.
- New diagnosis or exacerbation of major depression in the last 6 months.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (52)
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
Viking Clinical Research Center - Temecula /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, LLC /ID# 267815
Springfield, Massachusetts, 01103, United States
Psychiatric Care And Research Center /ID# 271701
O'Fallon, Missouri, 63368, United States
St. 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 (Altea) /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
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 21, 2025
First Posted
February 26, 2025
Study Start
April 29, 2025
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
November 1, 2026
Last Updated
January 23, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
- Access Criteria
- To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
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.