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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Generalized Anxiety Disorder (GAD)

In brief

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.

Key facts

Study ID

NCT06846320

Run by

AbbVie

People needed

315

Starts

2025-04-29

Expected to finish

2026-11-01

Last updated by the study team

2026-06-17

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 protocol-specified antidepressant therapies (ADT) for GAD 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.

You may not qualify if…

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

Where it is running

• Ima Clinical Research Phoenix (Alea) /ID# 275737 — Phoenix, Arizona, United States (enrolling)
• University of Alabama - Huntsville Regional Medical Campus /ID# 267818 — Huntsville, Alabama, United States (enrolling)
• Advanced Research Center /ID# 267874 — Anaheim, California, United States (enrolling)
• Axiom Research /ID# 267814 — Colton, California, United States (enrolling)
• Sun Valley Research Center /ID# 267864 — Imperial, California, United States (enrolling)
• Synergy San Diego /ID# 267879 — Lemon Grove, California, United States (enrolling)
• Alliance for Research Alliance for Wellness /ID# 267911 — Long Beach, California, United States (enrolling)
• NRC Research Institute DTLA /ID# 267832 — Los Angeles, California, United States (enrolling)
• Excell Research /ID# 267918 — Oceanside, California, United States (enrolling)
• Inland Psychiatric Medical Group /ID# 268598 — Temecula, California, United States (enrolling)
• Sunwise Clinical Research /ID# 267863 — Walnut Creek, California, United States (enrolling)
• Connecticut Clinical Research - Cromwell /ID# 271241 — Cromwell, Connecticut, United States (enrolling)
• Cns Healthcare - Jacksonville /ID# 268588 — Jacksonville, Florida, United States (enrolling)
• Accel Research Sites Network - St. Pete /ID# 267821 — Largo, Florida, United States (enrolling)
• K2 Medical Research, LLC /ID# 267841 — Maitland, Florida, United States (enrolling)
• GMI Florida - Central Miami Medical Institute /ID# 267839 — Miami, Florida, United States (enrolling)
• Allied Biomedical Res Inst Inc /ID# 267813 — Miami, Florida, United States (enrolling)
• Apg Research /ID# 271707 — Orlando, Florida, United States (enrolling)
• Psych Atlanta /ID# 267878 — Marietta, Georgia, United States (enrolling)
• iResearch Savannah /ID# 267865 — Savannah, Georgia, United States (enrolling)
• University of Chicago Medical Center /ID# 275131 — Chicago, Illinois, United States (enrolling)
• Collective Medical Research /ID# 272015 — Overland Park, Kansas, United States (enrolling)
• CenExel /ID# 267853 — Gaithersburg, Maryland, United States (enrolling)
• Elixia - Springfield /ID# 267815 — Springfield, Massachusetts, United States (enrolling)
• Psychiatric Care And Research Center /ID# 271701 — O'Fallon, Missouri, United States (enrolling)

Full record on ClinicalTrials.gov

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