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

What this study is about

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 can join (things the study team will check)

✅ You may be able to join 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 be able to join if…

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

Where this trial is running

• 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
• Inland Psychiatric Medical Group /ID# 268598, Temecula, California, United States
• Sunwise Clinical Research /ID# 267863, Walnut Creek, California, United States

+ 40 more sites.

Who to contact

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

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06846320.