RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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

Quick Facts

Study Start:2025-04-29
Study Completion:2026-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06846320

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.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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).
  2. * 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.
  1. * Have a Montgomery-Åsberg Depression Rating Scale (MADRS) score \>= 20.
  2. * New diagnosis or exacerbation of major depression in the last 6 months.

Contacts and Locations

Study Contact

ABBVIE CALL CENTER
CONTACT
844-663-3742
abbvieclinicaltrials@abbvie.com

Principal Investigator

ABBVIE INC.
STUDY_DIRECTOR
AbbVie

Study Locations (Sites)

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
GMI Florida - Central Miami Medical Institute /ID# 267839
Miami, Florida, 33125-3724
United States
New Hope Clinical Research - Inpatient unit /ID# 267810
Charlotte, North Carolina, 28211
United States
Sooner Clinical Research /ID# 267881
Oklahoma City, Oklahoma, 73116
United States
Grayline Research Center /ID# 267811
Wichita Falls, Texas, 76309
United States
Northwest Clinical Research Center /ID# 267916
Bellevue, Washington, 98007
United States

Collaborators and Investigators

Sponsor: AbbVie

  • ABBVIE INC., STUDY_DIRECTOR, AbbVie

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 Registration Dates

Study Start Date2025-04-29
Study Completion Date2026-11

Study Record Updates

Study Start Date2025-04-29
Study Completion Date2026-11

Terms related to this study

Keywords Provided by Researchers

  • LEGATO - (GAD)
  • Generalized Anxiety Disorder (GAD)
  • ABBV-932

Additional Relevant MeSH Terms

  • Generalized Anxiety Disorder (GAD)