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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

NCT06846320 · AbbVie
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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
About this study
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.
Study design
Enrollment target: 315 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2025-04-29
Estimated completion: 2026-11
Last updated: 2026-01-23
Interventions
Drug: ABBV-932Drug: Placebo for ABBV-932Drug: Antidepressant Therapy (ADT)
Primary outcomes
  • Number of Participants with Adverse Events (AEs) (Up to approximately 10 weeks)
  • Change from Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score (Up to approximately 6 weeks)
Sponsor
AbbVie · industry
Contacts & investigators
ContactABBVIE CALL CENTER · contact · abbvieclinicaltrials@abbvie.com · 844-663-3742
InvestigatorABBVIE INC. · study_director, AbbVie
All locations (52)
University of Alabama - Huntsville Regional Medical Campus /ID# 267818Recruiting
Huntsville, Alabama, United States
Ima Clinical Research Phoenix (Alea) /ID# 275737Recruiting
Phoenix, Arizona, United States
Noble Clinical Research /ID# 267952Completed
Tucson, Arizona, United States
Advanced Research Center /ID# 267874Recruiting
Anaheim, California, United States
Axiom Research /ID# 267814Recruiting
Colton, California, United States
Sun Valley Research Center /ID# 267864Recruiting
Imperial, California, United States
Synergy San Diego /ID# 267879Recruiting
Lemon Grove, California, United States
Alliance for Research Alliance for Wellness /ID# 267911Recruiting
Long Beach, California, United States
NRC Research Institute DTLA /ID# 267832Recruiting
Los Angeles, California, United States
Excell Research /ID# 267918Recruiting
Oceanside, California, United States
Viking Clinical Research Center - Temecula /ID# 268598Recruiting
Temecula, California, United States
Sunwise Clinical Research /ID# 267863Recruiting
Walnut Creek, California, United States
Connecticut Clinical Research - Cromwell /ID# 271241Recruiting
Cromwell, Connecticut, United States
Cns Healthcare - Jacksonville /ID# 268588Recruiting
Jacksonville, Florida, United States
Accel Research Sites Network - St. Pete /ID# 267821Recruiting
Largo, Florida, United States
K2 Medical Research, LLC /ID# 267841Recruiting
Maitland, Florida, United States
GMI Florida - Central Miami Medical Institute /ID# 267839Recruiting
Miami, Florida, United States
Allied Biomedical Res Inst Inc /ID# 267813Recruiting
Miami, Florida, United States
Apg Research /ID# 271707Recruiting
Orlando, Florida, United States
Psych Atlanta /ID# 267878Recruiting
Marietta, Georgia, United States
iResearch Savannah /ID# 267865Recruiting
Savannah, Georgia, United States
University of Chicago Medical Center /ID# 275131Recruiting
Chicago, Illinois, United States
Collective Medical Research /ID# 272015Recruiting
Overland Park, Kansas, United States
CenExel /ID# 267853Recruiting
Gaithersburg, Maryland, United States
Elixia, LLC /ID# 267815Recruiting
Springfield, Massachusetts, United States
Psychiatric Care And Research Center /ID# 271701Recruiting
O'Fallon, Missouri, United States
St. Charles Psychiatric Associates /ID# 271202Recruiting
Saint Charles, Missouri, United States
Arch Clinical Trials /ID# 267851Recruiting
St Louis, Missouri, United States
Ima Clinical Research Las Vegas (Altea) /ID# 275731Recruiting
Las Vegas, Nevada, United States
Duplicate_Oasis Clinical Research, LLC /ID# 267953Completed
Las Vegas, Nevada, United States
Princeton Medical Institute /ID# 267877Recruiting
Princeton, New Jersey, United States
Bio Behavioral Health /ID# 267919Recruiting
Toms River, New Jersey, United States
Integrative Clinical Trials /ID# 279519Recruiting
Brooklyn, New York, United States
New Hope Clinical Research - Inpatient unit /ID# 267810Recruiting
Charlotte, North Carolina, United States
Quest Therapeutics of Avon /ID# 267829Recruiting
Avon Lake, Ohio, United States
University Of Cincinnati Medical Center /ID# 271704Recruiting
Cincinnati, Ohio, United States
The Ohio State University /ID# 267924Recruiting
Columbus, Ohio, United States
Sooner Clinical Research /ID# 267881Recruiting
Oklahoma City, Oklahoma, United States
Lehigh Center for Clinical Research /ID# 267908Recruiting
Allentown, Pennsylvania, United States
Suburban Research Associates /ID# 267868Recruiting
West Chester, Pennsylvania, United States
Coastal Carolina Research Center, LLC /ID# 267826Recruiting
Charleston, South Carolina, United States
Psychiatric Consultants - Franklin /ID# 275133Recruiting
Franklin, Tennessee, United States
FutureSearch Trials of Dallas /ID# 267870Recruiting
Dallas, Texas, United States
Relaro Medical Trials /ID# 270241Recruiting
Dallas, Texas, United States
Perceptive Pharma Research /ID# 267836Recruiting
Richmond, Texas, United States
Family Psychiatry Of The Woodlands /ID# 275173Recruiting
The Woodlands, Texas, United States
Grayline Research Center /ID# 267811Recruiting
Wichita Falls, Texas, United States
Northwest Clinical Research Center /ID# 267916Recruiting
Bellevue, Washington, United States
Core Clinical Research /ID# 270058Recruiting
Everett, Washington, United States
INSPIRA Clinical Research /ID# 267822Recruiting
San Juan, Puerto Rico
Instituto De Neurologia Dra. Ivonne Fraga, Psc /ID# 267793Recruiting
San Juan, Puerto Rico
BDH Research /ID# 267787Recruiting
San Juan, Puerto Rico