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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.
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
No
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
Start Date
April 29, 2025
Primary Completion Date
November 1, 2026
Completion Date
November 1, 2026
Last Updated
January 23, 2026
315
ESTIMATED participants
ABBV-932
DRUG
Placebo for ABBV-932
DRUG
Antidepressant Therapy (ADT)
DRUG
Lead Sponsor
AbbVie
NCT07429578
NCT07430800
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07391020