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
NCT ID: NCT06846320
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
315 participants
INTERVENTIONAL
2025-04-29
2026-11-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ABBV-932 Dose A
Participants will receive ABBV-932 dose A in addition to prescribed antidepressant therapies (ADTs).
ABBV-932
Oral Capsule
Antidepressant Therapy (ADT)
Standard of care
ABBV-932 Dose B
Participants will receive ABBV-932 dose B in addition to prescribed antidepressant therapies (ADTs).
ABBV-932
Oral Capsule
Antidepressant Therapy (ADT)
Standard of care
Placebo for ABBV-932
Participants will receive placebo for ABBV-932 in addition to prescribed antidepressant therapies (ADTs).
Placebo for ABBV-932
Oral Capsule
Antidepressant Therapy (ADT)
Standard of care
Interventions
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ABBV-932
Oral Capsule
Placebo for ABBV-932
Oral Capsule
Antidepressant Therapy (ADT)
Standard of care
Eligibility Criteria
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Inclusion Criteria
* 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
* New diagnosis or exacerbation of major depression in the last 6 months.
18 Years
65 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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University of Alabama - Huntsville Regional Medical Campus /ID# 267818
Huntsville, Alabama, United States
Ima Clinical Research Phoenix (Alea) /ID# 275737
Phoenix, Arizona, United States
Noble Clinical Research /ID# 267952
Tucson, Arizona, United States
Advanced Research Center /ID# 267874
Anaheim, California, United States
Axiom Research /ID# 267814
Colton, California, United States
Sun Valley Research Center /ID# 267864
Imperial, California, United States
Synergy San Diego /ID# 267879
Lemon Grove, California, United States
Alliance for Research Alliance for Wellness /ID# 267911
Long Beach, California, United States
NRC Research Institute DTLA /ID# 267832
Los Angeles, California, United States
Excell Research /ID# 267918
Oceanside, California, United States
Viking Clinical Research Center - Temecula /ID# 268598
Temecula, California, United States
Sunwise Clinical Research /ID# 267863
Walnut Creek, California, United States
Connecticut Clinical Research - Cromwell /ID# 271241
Cromwell, Connecticut, United States
Cns Healthcare - Jacksonville /ID# 268588
Jacksonville, Florida, United States
Accel Research Sites Network - St. Pete /ID# 267821
Largo, Florida, United States
K2 Medical Research, LLC /ID# 267841
Maitland, Florida, United States
GMI Florida - Central Miami Medical Institute /ID# 267839
Miami, Florida, United States
Allied Biomedical Res Inst Inc /ID# 267813
Miami, Florida, United States
Apg Research /ID# 271707
Orlando, Florida, United States
Psych Atlanta /ID# 267878
Marietta, Georgia, United States
iResearch Savannah /ID# 267865
Savannah, Georgia, United States
Collective Medical Research /ID# 272015
Overland Park, Kansas, United States
CenExel /ID# 267853
Gaithersburg, Maryland, United States
Elixia, LLC /ID# 267815
Springfield, Massachusetts, United States
Psychiatric Care And Research Center /ID# 271701
O'Fallon, Missouri, United States
St. Charles Psychiatric Associates /ID# 271202
Saint Charles, Missouri, United States
Arch Clinical Trials /ID# 267851
St Louis, Missouri, United States
Ima Clinical Research Las Vegas (Altea) /ID# 275731
Las Vegas, Nevada, United States
Duplicate_Oasis Clinical Research, LLC /ID# 267953
Las Vegas, Nevada, United States
Princeton Medical Institute /ID# 267877
Princeton, New Jersey, United States
Bio Behavioral Health /ID# 267919
Toms River, New Jersey, United States
New Hope Clinical Research - Inpatient unit /ID# 267810
Charlotte, North Carolina, United States
Quest Therapeutics of Avon /ID# 267829
Avon Lake, Ohio, United States
University Of Cincinnati Medical Center /ID# 271704
Cincinnati, Ohio, United States
The Ohio State University /ID# 267924
Columbus, Ohio, United States
Sooner Clinical Research /ID# 267881
Oklahoma City, Oklahoma, United States
Lehigh Center for Clinical Research /ID# 267908
Allentown, Pennsylvania, United States
Suburban Research Associates /ID# 267868
West Chester, Pennsylvania, United States
Coastal Carolina Research Center, LLC /ID# 267826
Charleston, South Carolina, United States
Psychiatric Consultants - Franklin /ID# 275133
Franklin, Tennessee, United States
Relaro Medical Trials /ID# 270241
Dallas, Texas, United States
Perceptive Pharma Research /ID# 267836
Richmond, Texas, United States
Family Psychiatry Of The Woodlands /ID# 275173
The Woodlands, Texas, United States
Grayline Research Center /ID# 267811
Wichita Falls, Texas, United States
Northwest Clinical Research Center /ID# 267916
Bellevue, Washington, United States
Core Clinical Research /ID# 270058
Everett, Washington, United States
INSPIRA Clinical Research /ID# 267822
San Juan, , Puerto Rico
Instituto De Neurologia Dra. Ivonne Fraga, Psc /ID# 267793
San Juan, , Puerto Rico
BDH Research /ID# 267787
San Juan, , Puerto Rico
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Other Identifiers
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M25-099
Identifier Type: -
Identifier Source: org_study_id