Skip to main content
OpenTrials
Recruiting

NCT Number: 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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

BDH Research /ID# 267787, San Juan, Puerto Rico

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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.

Exclusion criteria

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

Treatment and study plan

ABBV-932

Drug

Oral Capsule

Placebo for ABBV-932

Drug

Oral Capsule

Antidepressant Therapy (ADT)

Drug

Standard of care

Primary outcomes

  1. Number of Participants with Adverse Events (AEs)

    Time frame: Up to approximately 10 weeks

    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.

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

    Time frame: Up to approximately 6 weeks

    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.

Secondary outcomes

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

    Time frame: Up to approximately 6 weeks

    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.

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

    Time frame: Up to approximately 6 weeks

    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.

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

    Time frame: Up to approximately 4 weeks

    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.

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

    Time frame: Up to approximately 6 weeks

    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.

  5. Percentage of Participants in Remission

    Time frame: Up to approximately 6 weeks

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

  6. Percentage of Participants with HAM-A Response

    Time frame: Up to approximately 6 weeks

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

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

    Time frame: Up to approximately 6 weeks

    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).

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

    Time frame: Up to approximately 6 weeks

    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.

  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"

    Time frame: Up to approximately 6 weeks

    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

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

    Time frame: Up to approximately 6 weeks

    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.

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

    Time frame: Up to approximately 6 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

ABBVIE CALL CENTER

CONTACT

[email protected]

844-663-3742

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 26, 2025
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.