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Generalized Anxiety Disorder (GAD)Phase 2NCT06846320

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

A Phase 2 study testing ABBV-932 and Antidepressant Therapy (ADT) in people with Generalized Anxiety Disorder (GAD), run by AbbVie at 52 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Generalized Anxiety Disorder (GAD)
What is being tested?
ABBV-932 and Antidepressant Therapy (ADT)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
315 participants
Where
52 sitesin 2 countries
Study dates
29 Apr 2025to Nov 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 protocol-specified antidepressant therapies (ADT) for GAD 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.

Who cannot join

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

Trial locations and contacts

52 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

ABBVIE CALL CENTER contact

844-663-3742

abbvieclinicaltrials@abbvie.com

52 sites in 2 countries

United States49 sites, 47 recruiting

  • Lehigh Center for Clinical Research /ID# 267908

    Allentown, Pennsylvania, 18103

    Recruiting

  • Advanced Research Center /ID# 267874

    Anaheim, California, 92805

    Site Coordinator, 714-999-6688

    Recruiting

  • Quest Therapeutics of Avon /ID# 267829

    Avon Lake, Ohio, 44012-1004

    Site Coordinator, 440-949-9115

    Recruiting

  • Northwest Clinical Research Center /ID# 267916

    Bellevue, Washington, 98007

    Recruiting

  • Integrative Clinical Trials /ID# 279519

    Brooklyn, New York, 11229

    Recruiting

  • Coastal Carolina Research Center, LLC /ID# 267826

    Charleston, South Carolina, 29492

    Site Coordinator, 321-878-9477

    Recruiting

  • New Hope Clinical Research - Inpatient unit /ID# 267810

    Charlotte, North Carolina, 28211

    Site Coordinator, 980-209-9784

    Recruiting

  • University of Chicago Medical Center /ID# 275131

    Chicago, Illinois, 60637

    Recruiting

  • University Of Cincinnati Medical Center /ID# 271704

    Cincinnati, Ohio, 45219

    Recruiting

  • Axiom Research /ID# 267814

    Colton, California, 92324

    Site Coordinator, 909-824-2325

    Recruiting

  • The Ohio State University /ID# 267924

    Columbus, Ohio, 43210

    Recruiting

  • Connecticut Clinical Research - Cromwell /ID# 271241

    Cromwell, Connecticut, 06416

    Recruiting

  • FutureSearch Trials of Dallas /ID# 267870

    Dallas, Texas, 75231

    Recruiting

  • Relaro Medical Trials /ID# 270241

    Dallas, Texas, 75243

    Recruiting

  • Core Clinical Research /ID# 270058

    Everett, Washington, 98201

    Recruiting

  • Psychiatric Consultants - Franklin /ID# 275133

    Franklin, Tennessee, 37067

    Site Coordinator, 615-807-4023

    Recruiting

  • CenExel /ID# 267853

    Gaithersburg, Maryland, 20877-1407

    Site Coordinator, 301-251-4702

    Recruiting

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

    Huntsville, Alabama, 35801

    Site Coordinator, 256-551-4431

    Recruiting

  • Sun Valley Research Center /ID# 267864

    Imperial, California, 92251

    Site Coordinator, 760-545-0123

    Recruiting

  • Cns Healthcare - Jacksonville /ID# 268588

    Jacksonville, Florida, 32256

    Recruiting

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

    Largo, Florida, 33777

    Site Coordinator, 321-878-9477

    Recruiting

  • Ima Clinical Research Las Vegas (SMO/Network/Consortium) /ID# 275731

    Las Vegas, Nevada, 89102

    Recruiting

  • Duplicate_Oasis Clinical Research, LLC /ID# 267953

    Las Vegas, Nevada, 89121

    Completed

  • Synergy San Diego /ID# 267879

    Lemon Grove, California, 91945

    Recruiting

  • Alliance for Research Alliance for Wellness /ID# 267911

    Long Beach, California, 90807

    Recruiting

  • NRC Research Institute DTLA /ID# 267832

    Los Angeles, California, 90015

    Site Coordinator, 714-289-1100

    Recruiting

  • K2 Medical Research, LLC /ID# 267841

    Maitland, Florida, 32751

    Recruiting

  • Psych Atlanta /ID# 267878

    Marietta, Georgia, 30060

    Recruiting

  • GMI Florida - Central Miami Medical Institute /ID# 267839

    Miami, Florida, 33125

    Site Coordinator, 305-547-2011

    Recruiting

  • Allied Biomedical Res Inst Inc /ID# 267813

    Miami, Florida, 33155

    Site Coordinator, 305-643-8400

    Recruiting

  • Psychiatric Care And Research Center /ID# 271701

    O'Fallon, Missouri, 63368

    Recruiting

  • Excell Research /ID# 267918

    Oceanside, California, 92056

    Recruiting

  • Sooner Clinical Research /ID# 267881

    Oklahoma City, Oklahoma, 73116

    Recruiting

  • Apg Research /ID# 271707

    Orlando, Florida, 32803

    Recruiting

  • Collective Medical Research /ID# 272015

    Overland Park, Kansas, 66210

    Recruiting

  • Ima Clinical Research Phoenix (Alea) /ID# 275737

    Phoenix, Arizona, 85012

    Recruiting

  • Princeton Medical Institute /ID# 267877

    Princeton, New Jersey, 08540

    Site Coordinator, 609-921-3555

    Recruiting

  • Perceptive Pharma Research /ID# 267836

    Richmond, Texas, 77407

    Site Coordinator, 346-467-2182

    Recruiting

  • Saint Charles Psychiatric Associates /ID# 271202

    Saint Charles, Missouri, 63304

    Recruiting

  • iResearch Savannah /ID# 267865

    Savannah, Georgia, 31405

    Site Coordinator, 912-744-0800

    Recruiting

  • Elixia - Springfield /ID# 267815

    Springfield, Massachusetts, 01103

    Recruiting

  • Arch Clinical Trials /ID# 267851

    St Louis, Missouri, 63125

    Recruiting

  • Inland Psychiatric Medical Group /ID# 268598

    Temecula, California, 92591

    Recruiting

  • Family Psychiatry Of The Woodlands /ID# 275173

    The Woodlands, Texas, 77381

    Recruiting

  • Bio Behavioral Health /ID# 267919

    Toms River, New Jersey, 08755

    Recruiting

  • Noble Clinical Research /ID# 267952

    Tucson, Arizona, 85704

    Completed

  • Sunwise Clinical Research /ID# 267863

    Walnut Creek, California, 94596

    Site Coordinator, 925-298-5147

    Recruiting

  • Suburban Research Associates /ID# 267868

    West Chester, Pennsylvania, 19380-4370

    Site Coordinator, 610-891-7200

    Recruiting

  • Grayline Research Center /ID# 267811

    Wichita Falls, Texas, 76309

    Site Coordinator, 940-322-1131

    Recruiting

Other trials in United States

Puerto Rico3 sites, 3 recruiting

  • Inspira Clinical Research /ID# 267822

    San Juan, 00918-3014

    Recruiting

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

    San Juan, 00918

    Site Coordinator, 787-763-9312

    Recruiting

  • BDH Research /ID# 267787

    San Juan, 00927

    Site Coordinator, 787-523-9808

    Recruiting

Other trials in Puerto Rico

About this study

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

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.

Read more

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.

Being tested
ABBV-932, Placebo for ABBV-932, Antidepressant Therapy (ADT)
Keywords
LEGATO - (GAD), Generalized Anxiety Disorder (GAD), ABBV-932
Medical subject headings
Generalized Anxiety Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ABBV-932Drug

    Oral Capsule

  • Placebo for ABBV-932Drug

    Oral Capsule

  • Antidepressant Therapy (ADT)Drug

    Standard of care

Study groups in NCT06846320
Study groupRoleWhat they receive
ABBV-932 Dose AExperimentalParticipants will receive ABBV-932 dose A in addition to prescribed antidepressant therapies (ADTs).
Receives: Drug: ABBV-932; Drug: Antidepressant Therapy (ADT)
ABBV-932 Dose BExperimentalParticipants will receive ABBV-932 dose B in addition to prescribed antidepressant therapies (ADTs).
Receives: Drug: ABBV-932; Drug: Antidepressant Therapy (ADT)
Placebo for ABBV-932Placebo comparatorParticipants will receive placebo for ABBV-932 in addition to prescribed antidepressant therapies (ADTs).
Receives: Drug: Placebo for ABBV-932; Drug: Antidepressant Therapy (ADT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants with Adverse Events (AEs)

    An AE is defined as any untoward medical occurrence in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

    Measured: Up to approximately 10 weeks

  2. Change from Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score

    The HAM-A is a 14-item, clinician-reported measure used to quantify and categorize the participant's anxiety over the past week. Items are rated on a 5-point Likert rating scale. The HAM-A total score ranges from 0 to 56, with higher scores indicating greater anxiety severity.

    Measured: Up to approximately 6 weeks

Secondary outcomes (11)

  1. Change from Baseline in Penn State Worry Questionnaire-10 (PSWQ-10) Total Score

    The PSWQ-10 is a 10-item, participant-reported measure of the tendency of an individual to worry, the excessiveness or intensity of worry, and the tendency for the worry to be generalized and not restricted to a small number of situations. Items are rated from 0 to 6 (0, never; 6, almost always). Total scores range from 0 to 60, with higher scores indicating greater worry.

    Measured: Up to approximately 6 weeks

  2. Change from Baseline in Clinical Global Impression of Severity Scale (CGI-S) Generalized Anxiety Disorder (GAD)

    The CGI-S GAD is a single, clinician-reported item that measures the clinician's impression of a participant's current anxiety severity considering their total clinical experience with the participant population. The measure uses a 7-point Likert rating scale, with higher scores indicating greater anxiety severity.

    Measured: Up to approximately 6 weeks

  3. Change from Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score

    The HAM-A is a 14-item, clinician-reported measure used to quantify and categorize the participant's anxiety over the past week. Items are rated on a 5-point Likert rating scale. The HAM-A total score ranges from 0 to 56, with higher scores indicating greater anxiety severity.

    Measured: Up to approximately 4 weeks

  4. Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score

    The MADRS is a 10-item, clinician-rated scale that evaluates the participant's depressive symptomatology during the past week. Participants are rated on items assessing feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty in concentration, and lack of interest. Each item is scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity.

    Measured: Up to approximately 6 weeks

  5. Percentage of Participants in Remission

    Remission is defined as HAM-A total score <=7.

    Measured: Up to approximately 6 weeks

  6. Percentage of Participants with HAM-A Response

    HAM-A response is defined as >= 50% reduction from baseline in HAM-A total score

    Measured: Up to approximately 6 weeks

  7. Percentage of Participants with Clinical Global Impression of Change (CGI-C) GAD Responder Status of "Much Better" or "Moderately Better"

    The CGI-C GAD is a clinician-rated scale that measures the overall change in a participant's GAD symptoms since initial receipt of the study medication. The participant is rated on a 7-point Likert scale ranging from "Much better" (1) to "Much worse" (7).

    Measured: Up to approximately 6 weeks

  8. Change from Baseline in Patient Global Impression of Severity Scale (PGI-S) Generalized Anxiety Disorder (GAD)

    The PGI-S GAD is a single, patient-reported item that assesses the subject's perceived level of GAD symptoms over the past 7 days. The measure uses a 5-point Likert rating scale with responses ranging from "no symptoms" (1) to "very severe" (5), with higher scores indicating greater severity of GAD symptoms.

    Measured: Up to approximately 6 weeks

  9. Percentage of Participants with Patient Global Impression of Change Scale (PGI-C) Generalized Anxiety Disorder (GAD) Responder Status of "Much Better" or "Moderately Better"

    The PGI-C GAD is a single, patient-reported item that assesses the subject's perceived overall change in their GAD symptoms since they started taking the study medication. The measure uses a 7-point Likert rating scale with responses ranging from "much better" (1) to "much worse" (7). Higher scores indicate worse GAD symptoms

    Measured: Up to approximately 6 weeks

  10. Change from Baseline in Patient Global Impression of Severity Scale (PGI-S) Worry

    The PGI-C Worry is a single, patient-reported item that assesses the subject's perceived overall change in their worry since they started taking the study medication. The measure uses a 7-point Likert rating scale with responses ranging from "much less worried" (1) to "much more worried" (7). Higher scores indicate more worry.

    Measured: Up to approximately 6 weeks

  11. Percentage of Participants with Patient Global Impression of Change Scale (PGI-C) Worry Responder Status of "Much Better" or "Moderately Better"

    The PGI-C Worry is a single, patient-reported item that assesses the subject's perceived overall change in their worry since they started taking the study medication. The measure uses a 7-point Likert rating scale with responses ranging from "much less worried" (1) to "much more worried" (7). Higher scores indicate more worry.

    Measured: Up to approximately 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Feb 2025
  2. Study start29 Apr 2025
  3. Primary completionNov 2026 (estimated)
  4. Study completionNov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
315 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06846320
Sponsor's protocol ID
M25-099
Status last verified
Jun 2026
First submitted
21 Feb 2025
Last updated
17 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ABBV-932 and Antidepressant Therapy (ADT) in people with Generalized Anxiety Disorder (GAD), run by AbbVie at 52 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 52 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact ABBVIE CALL CENTER (844-663-3742, abbvieclinicaltrials@abbvie.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Adverse Events (AEs) (time frame: Up to approximately 10 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06846320.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.

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