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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

RecruitingPhase 2Ages 18 Years - 65 YearsAllAbbVie
NCT06846320 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

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📋 Eligibility rules (as published)
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 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. Exclusion Criteria: * Have a Montgomery-Åsberg Depression Rating Scale (MADRS) score \>= 20. * New diagnosis or exacerbation of major depression in the last 6 months.
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What it tests

  • ABBV-932
  • Placebo for ABBV-932
  • Antidepressant Therapy (ADT)
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Where

52 sites
University of Alabama - Huntsville Regional Medical Campus /ID# 267818
Huntsville, United States
Ima Clinical Research Phoenix (Alea) /ID# 275737
Phoenix, United States
Noble Clinical Research /ID# 267952
Tucson, United States
Advanced Research Center /ID# 267874
Anaheim, United States
Axiom Research /ID# 267814
Colton, United States
Sun Valley Research Center /ID# 267864
Imperial, United States
Synergy San Diego /ID# 267879
Lemon Grove, United States
Alliance for Research Alliance for Wellness /ID# 267911
Long Beach, United States

…and 44 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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