Actively Recruiting

Phase 2
Age: 18Years - 65Years
All Genders
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

Led by AbbVie · Updated on 2026-01-23

315

Participants Needed

52

Research Sites

78 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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.
Not Eligible

You will not qualify if you...

  • Have a Montgomery-Åsberg Depression Rating Scale (MADRS) score >= 20.
  • New diagnosis or exacerbation of major depression in the last 6 months.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 52 locations

1

University of Alabama - Huntsville Regional Medical Campus /ID# 267818

Huntsville, Alabama, United States, 35801

Actively Recruiting

2

Ima Clinical Research Phoenix (Alea) /ID# 275737

Phoenix, Arizona, United States, 85012

Actively Recruiting

3

Noble Clinical Research /ID# 267952

Tucson, Arizona, United States, 85704

Completed

4

Advanced Research Center /ID# 267874

Anaheim, California, United States, 92805

Actively Recruiting

5

Axiom Research /ID# 267814

Colton, California, United States, 92324

Actively Recruiting

6

Sun Valley Research Center /ID# 267864

Imperial, California, United States, 92251

Actively Recruiting

7

Synergy San Diego /ID# 267879

Lemon Grove, California, United States, 91945

Actively Recruiting

8

Alliance for Research Alliance for Wellness /ID# 267911

Long Beach, California, United States, 90807

Actively Recruiting

9

NRC Research Institute DTLA /ID# 267832

Los Angeles, California, United States, 90015

Actively Recruiting

10

Excell Research /ID# 267918

Oceanside, California, United States, 92056

Actively Recruiting

11

Viking Clinical Research Center - Temecula /ID# 268598

Temecula, California, United States, 92591

Actively Recruiting

12

Sunwise Clinical Research /ID# 267863

Walnut Creek, California, United States, 94596

Actively Recruiting

13

Connecticut Clinical Research - Cromwell /ID# 271241

Cromwell, Connecticut, United States, 06416

Actively Recruiting

14

Cns Healthcare - Jacksonville /ID# 268588

Jacksonville, Florida, United States, 32256

Actively Recruiting

15

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

Largo, Florida, United States, 33777

Actively Recruiting

16

K2 Medical Research, LLC /ID# 267841

Maitland, Florida, United States, 32751

Actively Recruiting

17

GMI Florida - Central Miami Medical Institute /ID# 267839

Miami, Florida, United States, 33125

Actively Recruiting

18

Allied Biomedical Res Inst Inc /ID# 267813

Miami, Florida, United States, 33155

Actively Recruiting

19

Apg Research /ID# 271707

Orlando, Florida, United States, 32803

Actively Recruiting

20

Psych Atlanta /ID# 267878

Marietta, Georgia, United States, 30060

Actively Recruiting

21

iResearch Savannah /ID# 267865

Savannah, Georgia, United States, 31405

Actively Recruiting

22

University of Chicago Medical Center /ID# 275131

Chicago, Illinois, United States, 60637

Actively Recruiting

23

Collective Medical Research /ID# 272015

Overland Park, Kansas, United States, 66210

Actively Recruiting

24

CenExel /ID# 267853

Gaithersburg, Maryland, United States, 20877-1407

Actively Recruiting

25

Elixia, LLC /ID# 267815

Springfield, Massachusetts, United States, 01103

Actively Recruiting

26

Psychiatric Care And Research Center /ID# 271701

O'Fallon, Missouri, United States, 63368

Actively Recruiting

27

St. Charles Psychiatric Associates /ID# 271202

Saint Charles, Missouri, United States, 63304

Actively Recruiting

28

Arch Clinical Trials /ID# 267851

St Louis, Missouri, United States, 63125

Actively Recruiting

29

Ima Clinical Research Las Vegas (Altea) /ID# 275731

Las Vegas, Nevada, United States, 89102

Actively Recruiting

30

Duplicate_Oasis Clinical Research, LLC /ID# 267953

Las Vegas, Nevada, United States, 89121

Completed

31

Princeton Medical Institute /ID# 267877

Princeton, New Jersey, United States, 08540

Actively Recruiting

32

Bio Behavioral Health /ID# 267919

Toms River, New Jersey, United States, 08755

Actively Recruiting

33

Integrative Clinical Trials /ID# 279519

Brooklyn, New York, United States, 11229

Actively Recruiting

34

New Hope Clinical Research - Inpatient unit /ID# 267810

Charlotte, North Carolina, United States, 28211

Actively Recruiting

35

Quest Therapeutics of Avon /ID# 267829

Avon Lake, Ohio, United States, 44012-1004

Actively Recruiting

36

University Of Cincinnati Medical Center /ID# 271704

Cincinnati, Ohio, United States, 45219

Actively Recruiting

37

The Ohio State University /ID# 267924

Columbus, Ohio, United States, 43210

Actively Recruiting

38

Sooner Clinical Research /ID# 267881

Oklahoma City, Oklahoma, United States, 73116

Actively Recruiting

39

Lehigh Center for Clinical Research /ID# 267908

Allentown, Pennsylvania, United States, 18103

Actively Recruiting

40

Suburban Research Associates /ID# 267868

West Chester, Pennsylvania, United States, 19380-4370

Actively Recruiting

41

Coastal Carolina Research Center, LLC /ID# 267826

Charleston, South Carolina, United States, 29492

Actively Recruiting

42

Psychiatric Consultants - Franklin /ID# 275133

Franklin, Tennessee, United States, 37067

Actively Recruiting

43

FutureSearch Trials of Dallas /ID# 267870

Dallas, Texas, United States, 75231

Actively Recruiting

44

Relaro Medical Trials /ID# 270241

Dallas, Texas, United States, 75243

Actively Recruiting

45

Perceptive Pharma Research /ID# 267836

Richmond, Texas, United States, 77407

Actively Recruiting

46

Family Psychiatry Of The Woodlands /ID# 275173

The Woodlands, Texas, United States, 77381

Actively Recruiting

47

Grayline Research Center /ID# 267811

Wichita Falls, Texas, United States, 76309

Actively Recruiting

48

Northwest Clinical Research Center /ID# 267916

Bellevue, Washington, United States, 98007

Actively Recruiting

49

Core Clinical Research /ID# 270058

Everett, Washington, United States, 98201

Actively Recruiting

50

INSPIRA Clinical Research /ID# 267822

San Juan, Puerto Rico, 00918-3014

Actively Recruiting

51

Instituto De Neurologia Dra. Ivonne Fraga, Psc /ID# 267793

San Juan, Puerto Rico, 00918

Actively Recruiting

52

BDH Research /ID# 267787

San Juan, Puerto Rico, 00927

Actively Recruiting

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Research Team

A

ABBVIE CALL CENTER

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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