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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
Sponsor: AbbVie
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
315
Start Date
2025-04-29
Completion Date
2026-11
Last Updated
2026-01-23
Healthy Volunteers
No
Conditions
Interventions
ABBV-932
Oral Capsule
Placebo for ABBV-932
Oral Capsule
Antidepressant Therapy (ADT)
Standard of care
Locations (52)
University of Alabama - Huntsville Regional Medical Campus /ID# 267818
Huntsville, Alabama, United States
Ima Clinical Research Phoenix (Alea) /ID# 275737
Phoenix, Arizona, United States
Noble Clinical Research /ID# 267952
Tucson, Arizona, United States
Advanced Research Center /ID# 267874
Anaheim, California, United States
Axiom Research /ID# 267814
Colton, California, United States
Sun Valley Research Center /ID# 267864
Imperial, California, United States
Synergy San Diego /ID# 267879
Lemon Grove, California, United States
Alliance for Research Alliance for Wellness /ID# 267911
Long Beach, California, United States
NRC Research Institute DTLA /ID# 267832
Los Angeles, California, United States
Excell Research /ID# 267918
Oceanside, California, United States
Viking Clinical Research Center - Temecula /ID# 268598
Temecula, California, United States
Sunwise Clinical Research /ID# 267863
Walnut Creek, California, United States
Connecticut Clinical Research - Cromwell /ID# 271241
Cromwell, Connecticut, United States
Cns Healthcare - Jacksonville /ID# 268588
Jacksonville, Florida, United States
Accel Research Sites Network - St. Pete /ID# 267821
Largo, Florida, United States
K2 Medical Research, LLC /ID# 267841
Maitland, Florida, United States
GMI Florida - Central Miami Medical Institute /ID# 267839
Miami, Florida, United States
Allied Biomedical Res Inst Inc /ID# 267813
Miami, Florida, United States
Apg Research /ID# 271707
Orlando, Florida, United States
Psych Atlanta /ID# 267878
Marietta, Georgia, United States
iResearch Savannah /ID# 267865
Savannah, Georgia, United States
University of Chicago Medical Center /ID# 275131
Chicago, Illinois, United States
Collective Medical Research /ID# 272015
Overland Park, Kansas, United States
CenExel /ID# 267853
Gaithersburg, Maryland, United States
Elixia, LLC /ID# 267815
Springfield, Massachusetts, United States
Psychiatric Care And Research Center /ID# 271701
O'Fallon, Missouri, United States
St. Charles Psychiatric Associates /ID# 271202
Saint Charles, Missouri, United States
Arch Clinical Trials /ID# 267851
St Louis, Missouri, United States
Ima Clinical Research Las Vegas (Altea) /ID# 275731
Las Vegas, Nevada, United States
Duplicate_Oasis Clinical Research, LLC /ID# 267953
Las Vegas, Nevada, United States
Princeton Medical Institute /ID# 267877
Princeton, New Jersey, United States
Bio Behavioral Health /ID# 267919
Toms River, New Jersey, United States
Integrative Clinical Trials /ID# 279519
Brooklyn, New York, United States
New Hope Clinical Research - Inpatient unit /ID# 267810
Charlotte, North Carolina, United States
Quest Therapeutics of Avon /ID# 267829
Avon Lake, Ohio, United States
University Of Cincinnati Medical Center /ID# 271704
Cincinnati, Ohio, United States
The Ohio State University /ID# 267924
Columbus, Ohio, United States
Sooner Clinical Research /ID# 267881
Oklahoma City, Oklahoma, United States
Lehigh Center for Clinical Research /ID# 267908
Allentown, Pennsylvania, United States
Suburban Research Associates /ID# 267868
West Chester, Pennsylvania, United States
Coastal Carolina Research Center, LLC /ID# 267826
Charleston, South Carolina, United States
Psychiatric Consultants - Franklin /ID# 275133
Franklin, Tennessee, United States
FutureSearch Trials of Dallas /ID# 267870
Dallas, Texas, United States
Relaro Medical Trials /ID# 270241
Dallas, Texas, United States
Perceptive Pharma Research /ID# 267836
Richmond, Texas, United States
Family Psychiatry Of The Woodlands /ID# 275173
The Woodlands, Texas, United States
Grayline Research Center /ID# 267811
Wichita Falls, Texas, United States
Northwest Clinical Research Center /ID# 267916
Bellevue, Washington, United States
Core Clinical Research /ID# 270058
Everett, Washington, United States
INSPIRA Clinical Research /ID# 267822
San Juan, Puerto Rico
Instituto De Neurologia Dra. Ivonne Fraga, Psc /ID# 267793
San Juan, Puerto Rico
BDH Research /ID# 267787
San Juan, Puerto Rico