Featured Trial

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

Study Identifier
M25-099
CT.gov Identifier
NCT06846320
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Recruiting
Sign up for trial alerts
Interested in joining this trial?
See if You Qualify

Study Details

The Legato Study assesses the safety and effectiveness of an investigational treatment for generalized anxiety disorder (GAD). GAD involves excessive, ongoing worry (even when there is no reason) that you can’t control. It’s often diagnosed by a healthcare or mental health provider when worrying and anxiety occur on most days for at least 6 months. GAD is usually treated with antidepressant therapies (ADT). However, sometimes ADTs alone are not enough to adequately treat GAD.

The purpose of this study is to assess the safety and effectiveness of the investigational treatment when combined with ADTs in adults who have had an inadequate response to ADTs alone.

Medical Condition
  • Anxiety
    • Study Drug
  • ABBV-932
  • Placebo for ABBV-932
  • Antidepressant Therapy (ADT)
    • Phase
    Phase 2
    Estimated Enrollment
    315 patients

    Participating in our Generalized Anxiety Disorder Clinical Trials

    If you qualify, the Legato Study will consist of a 6-week study treatment period, plus a 4-week follow-up period. Eligible participants will be randomly assigned to receive the investigational treatment or placebo (a substance that looks like the investigational drug but contains no active medicine) in addition to their currently prescribed ADTs. Both will be administered as an oral capsule.

    During the study treatment period, you will be expected to attend all study visits, follow the directions of the dedicated medical team, and tell the doctor/study staff if you are feeling differently (either good or bad). You will also be asked to complete the self-administered questionnaires (called “scales”) on an electronic device during study visits. The care team may order a variety of exams and tests (e.g., physical exams, vital signs assessments, blood and urine tests).

    You will receive all study-related care at no cost. No health insurance is required to participate. You may be reimbursed for other costs associated with study participation.

    Study Participant Requirements

    Sex
    Female & Male
    Age
    18 - 65 Years

    Key Inclusion and Exclusion Criteria

    Participants must:

    • Be 18 to 65 years old
    • Be diagnosed with generalized anxiety disorder
    • Have had an inadequate response to a current antidepressant therapy

    Participants must not:

    • Have had a new major depressive episode in the last 6 months
    • Have a history of any schizophrenia, schizoaffective disorder, bipolar I or II disorder, or post-traumatic stress disorder
    • Have a history of cancer or a significant hematologic, endocrine, cardiovascular, respiratory, renal, hepatic, gastrointestinal, or neurological disorder (some exceptions apply)

    Inclusion and Exclusion Criteria
    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.

    Study Locations

    Location
    Status
    Location
    University of Alabama - Huntsville Regional Medical Campus /ID# 267818
    Huntsville, Alabama, United States, 35801
    Status
    Recruiting
    Location
    Ima Clinical Research Phoenix (Alea) /ID# 275737
    Phoenix, Arizona, United States, 85012
    Status
    Recruiting
    Location
    Noble Clinical Research /ID# 267952
    Tucson, Arizona, United States, 85704
    Status
    Completed
    Location
    Advanced Research Center /ID# 267874
    Anaheim, California, United States, 92805
    Status
    Recruiting
    Location
    Axiom Research /ID# 267814
    Colton, California, United States, 92324
    Status
    Recruiting
    Location
    Sun Valley Research Center /ID# 267864
    Imperial, California, United States, 92251
    Status
    Recruiting
    Showing {first} - {last} of {total} Results

    ABBV-US-0584_RM Version 1.0 Dec2025