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RECRUITINGPhase 2INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - Have a Montgomery-Åsberg Depression Rating Scale (MADRS) score \>= 20. - New diagnosis or exacerbation of major depression in the last 6 months. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion 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. Exclusion Criteria: * Have a Montgomery-Åsberg Depression Rating Scale (MADRS) score \>= 20. * New diagnosis or exacerbation of major depression in the last 6 months.

Treatments Being Tested

DRUG

ABBV-932

Oral Capsule

DRUG

Placebo for ABBV-932

Oral Capsule

DRUG

Antidepressant Therapy (ADT)

Standard of care

Locations (20)

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