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

Description

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 Overview

Study Details

Study overview

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.

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

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

Condition
Generalized Anxiety Disorder (GAD)
Intervention / Treatment

-

Contacts and Locations

Temecula

Viking Clinical Research Center - Temecula /ID# 268598, Temecula, California, United States, 92591

Walnut Creek

Sunwise Clinical Research /ID# 267863, Walnut Creek, California, United States, 94596

Cromwell

Connecticut Clinical Research - Cromwell /ID# 271241, Cromwell, Connecticut, United States, 06416

Jacksonville

Cns Healthcare - Jacksonville /ID# 268588, Jacksonville, Florida, United States, 32256

Largo

Accel Research Sites Network - St. Pete /ID# 267821, Largo, Florida, United States, 33777

Miami

GMI Florida - Central Miami Medical Institute /ID# 267839, Miami, Florida, United States, 33125-3724

Charlotte

New Hope Clinical Research - Inpatient unit /ID# 267810, Charlotte, North Carolina, United States, 28211

Oklahoma City

Sooner Clinical Research /ID# 267881, Oklahoma City, Oklahoma, United States, 73116

Wichita Falls

Grayline Research Center /ID# 267811, Wichita Falls, Texas, United States, 76309

Bellevue

Northwest Clinical Research Center /ID# 267916, Bellevue, Washington, United States, 98007

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * Have a Montgomery-Åsberg Depression Rating Scale (MADRS) score \>= 20.
  • * New diagnosis or exacerbation of major depression in the last 6 months.

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

AbbVie,

ABBVIE INC., STUDY_DIRECTOR, AbbVie

Study Record Dates

2026-11