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Recruiting 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

Phase II Interventional Generalized Anxiety Disorder (GAD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ABBV-932, Placebo for ABBV-932, Antidepressant Therapy (ADT).
Who it may be relevant to
Registry conditions: Generalized Anxiety Disorder (GAD). Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Puerto Rico
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Drug ABBV-932
    Oral Capsule
  • Drug Placebo for ABBV-932
    Oral Capsule
  • Drug Antidepressant Therapy (ADT)
    Standard of care

Primary outcome measures

  • Number of Participants with Adverse Events (AEs) [Time frame: Up to approximately 10 weeks]
  • Change from Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score [Time frame: Up to approximately 6 weeks]
Secondary outcome measures (11)
  • Change from Baseline in Penn State Worry Questionnaire-10 (PSWQ-10) Total Score [Time frame: Up to approximately 6 weeks]
  • Change from Baseline in Clinical Global Impression of Severity Scale (CGI-S) Generalized Anxiety Disorder (GAD) [Time frame: Up to approximately 6 weeks]
  • Change from Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score [Time frame: Up to approximately 4 weeks]
  • Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score [Time frame: Up to approximately 6 weeks]
  • Percentage of Participants in Remission [Time frame: Up to approximately 6 weeks]
  • Percentage of Participants with HAM-A Response [Time frame: Up to approximately 6 weeks]
  • 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]
  • Change from Baseline in Patient Global Impression of Severity Scale (PGI-S) Generalized Anxiety Disorder (GAD) [Time frame: Up to approximately 6 weeks]
  • 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]
  • Change from Baseline in Patient Global Impression of Severity Scale (PGI-S) Worry [Time frame: Up to approximately 6 weeks]
  • 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]

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 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 49 centers
  • University of Alabama - Huntsville Regional Medical Campus /ID# 267818 — Huntsville
  • Ima Clinical Research Phoenix (Alea) /ID# 275737 — Phoenix
  • Noble Clinical Research /ID# 267952 — Tucson
  • Advanced Research Center /ID# 267874 — Anaheim
  • Axiom Research /ID# 267814 — Colton
  • Sun Valley Research Center /ID# 267864 — Imperial
  • Synergy San Diego /ID# 267879 — Lemon Grove
  • Alliance for Research Alliance for Wellness /ID# 267911 — Long Beach
  • … and 41 more centers
Puerto Rico · 3 centers
  • Inspira Clinical Research /ID# 267822 — San Juan
  • Instituto De Neurologia Dra. Ivonne Fraga, Psc /ID# 267793 — San Juan
  • BDH Research /ID# 267787 — San Juan

Identifiers

NCT: NCT06846320 · M25-099

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗