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

Last updated: May 8, 2025
Sponsor: AbbVie
Overall Status: Active - Recruiting

Phase

2

Condition

Anxiety Disorders

Generalized Anxiety Disorder (Gad)

Panic Disorders

Treatment

ABBV-932

Antidepressant Therapy (ADT)

Placebo for ABBV-932

Clinical Study ID

NCT06846320
M25-099
  • Ages 18-65
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, TextRevision (DSM-5-TR) criteria for generalized anxiety disorder (GAD) confirmed by theMini International Neuropsychiatric Interview (MINI).

  • Currently taking one of the Food and Drug Administration (FDA) approvedantidepressant therapies (ADT) for GAD (i.e., escitalopram, paroxetine, duloxetine,or venlafaxine ER) with an inadequate response to an adequate dose (per label) andduration (>= 8 weeks) as verified by a baseline Hamilton Anxiety Rating Scale (HAM-A) total score >= 20 and Clinical Global Impression of Severity Scale (CGI-SGAD) >= 4.

Exclusion

Exclusion Criteria:

  • Have a Montgomery-Åsberg Depression Rating Scale (MADRS) score >= 20.

  • New diagnosis or exacerbation of major depression in the last 6 months.

Study Design

Total Participants: 315
Treatment Group(s): 3
Primary Treatment: ABBV-932
Phase: 2
Study Start date:
April 29, 2025
Estimated Completion Date:
November 30, 2026

Connect with a study center

  • Viking Clinical Research Center - Temecula /ID# 268598

    Temecula, California 92591
    United States

    Active - Recruiting

  • Sunwise Clinical Research /ID# 267863

    Walnut Creek, California 94596
    United States

    Active - Recruiting

  • Connecticut Clinical Research - Cromwell /ID# 271241

    Cromwell, Connecticut 06416
    United States

    Active - Recruiting

  • Cns Healthcare - Jacksonville /ID# 268588

    Jacksonville, Florida 32256
    United States

    Active - Recruiting

  • Accel Research Sites Network - St. Pete /ID# 267821

    Largo, Florida 33777
    United States

    Active - Recruiting

  • GMI Florida - Central Miami Medical Institute /ID# 267839

    Miami, Florida 33125-3724
    United States

    Active - Recruiting

  • New Hope Clinical Research - Inpatient unit /ID# 267810

    Charlotte, North Carolina 28211
    United States

    Active - Recruiting

  • Sooner Clinical Research /ID# 267881

    Oklahoma City, Oklahoma 73116
    United States

    Active - Recruiting

  • Grayline Research Center /ID# 267811

    Wichita Falls, Texas 76309
    United States

    Active - Recruiting

  • Northwest Clinical Research Center /ID# 267916

    Bellevue, Washington 98007
    United States

    Active - Recruiting

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