Clinical trial NCT06846320: 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
Official title: 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 type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Generalized Anxiety Disorder (GAD)
Keywords: LEGATO - (GAD)
Generalized Anxiety Disorder (GAD)
ABBV-932
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2025-02-26
Enrollment: 315
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Primary outcomes:
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Up to approximately 10 weeks
measure: Change from Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score
timeFrame: Up to approximately 6 weeks
Secondary outcomes:
measure: Change from Baseline in Penn State Worry Questionnaire-10 (PSWQ-10) Total Score
timeFrame: Up to approximately 6 weeks
measure: Change from Baseline in Clinical Global Impression of Severity Scale (CGI-S) Generalized Anxiety Disorder (GAD)
timeFrame: Up to approximately 6 weeks
measure: Change from Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score
timeFrame: Up to approximately 4 weeks
measure: Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
timeFrame: Up to approximately 6 weeks
measure: Percentage of Participants in Remission
timeFrame: Up to approximately 6 weeks
measure: Percentage of Participants with HAM-A Response
timeFrame: Up to approximately 6 weeks
measure: Percentage of Participants with Clinical Global Impression of Change (CGI-C) GAD Responder Status of "Much Better" or "Moderately Better"
timeFrame: Up to approximately 6 weeks
Other outcomes:
Locations:
city: Temecula
country: United States
facility: Viking Clinical Research Center - Temecula /ID# 268598
state: California
city: Walnut Creek
country: United States
facility: Sunwise Clinical Research /ID# 267863
state: California
city: Cromwell
country: United States
facility: Connecticut Clinical Research - Cromwell /ID# 271241
state: Connecticut
city: Jacksonville
country: United States
facility: Cns Healthcare - Jacksonville /ID# 268588
state: Florida
city: Largo
country: United States
facility: Accel Research Sites Network - St. Pete /ID# 267821
state: Florida
city: Miami
country: United States
facility: GMI Florida - Central Miami Medical Institute /ID# 267839
state: Florida
city: Charlotte
country: United States
facility: New Hope Clinical Research - Inpatient unit /ID# 267810
state: North Carolina
city: Oklahoma City
country: United States
facility: Sooner Clinical Research /ID# 267881
state: Oklahoma
city: Wichita Falls
country: United States
facility: Grayline Research Center /ID# 267811
state: Texas
city: Bellevue
country: United States
facility: Northwest Clinical Research Center /ID# 267916
state: Washington
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: