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NCT06846320 · ClinicalTrials.gov registry record · Phase 2
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 of Generalized Anxiety Disorder (GAD), sponsored by AbbVie.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 315
- Enrollment target
- 20
- Study locations
NCT06846320: Recruiting Phase 2 study of Generalized Anxiety Disorder (GAD), sponsored by AbbVie.
NCT06846320 is a Phase 2 study of Generalized Anxiety Disorder (GAD) that is actively recruiting participants, run by AbbVie. The registered enrollment target is 315 participants, above the 166-participant average among 6 other Generalized Anxiety Disorder (GAD) trials with a reported enrollment target (90% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06846320, a Phase 2 study of Generalized Anxiety Disorder (GAD), is actively recruiting participants, sponsored by AbbVie.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 315 participants
- Enrollment target
- 20
- Study locations
Study 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 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG ABBV-932
- DRUG Placebo for ABBV-932
- DRUG Antidepressant Therapy (ADT)
Study Locations (20)
California
- 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
- NRC Research Institute DTLA /ID# 267832 - Los Angeles
- Excell Research /ID# 267918 - Oceanside
- Viking Clinical Research Center - Temecula /ID# 268598 - Temecula
- Sunwise Clinical Research /ID# 267863 - Walnut Creek
Florida
- Cns Healthcare - Jacksonville /ID# 268588 - Jacksonville
- Accel Research Sites Network - St. Pete /ID# 267821 - Largo
- K2 Medical Research, LLC /ID# 267841 - Maitland
- GMI Florida - Central Miami Medical Institute /ID# 267839 - Miami
- Allied Biomedical Res Inst Inc /ID# 267813 - Miami
- Apg Research /ID# 271707 - Orlando
Arizona
- Ima Clinical Research Phoenix (Alea) /ID# 275737 - Phoenix
- Noble Clinical Research /ID# 267952 - Tucson
Alabama
- University of Alabama - Huntsville Regional Medical Campus /ID# 267818 - Huntsville
Connecticut
- Connecticut Clinical Research - Cromwell /ID# 271241 - Cromwell
Georgia
- Psych Atlanta /ID# 267878 - Marietta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 315 participants |
| Start Date | 2025-04-29 |
| Est. Completion | 2026-11 |
| Phase | Phase 2 |
What NCT06846320 shows while recruiting
NCT06846320 is an interventional study that assigns participants to a tested intervention. The registered 315 participants enrollment target is mid-sized for trials with a published cap, above the 166-participant average among 6 other Generalized Anxiety Disorder (GAD) trials with a reported enrollment target (90% higher).
The record links to 1 condition, with Generalized Anxiety Disorder (GAD) appearing as the primary indexed condition, and to 3 interventions - of which ABBV-932 is the first listed.
NCT06846320 names 20 study sites across 6 states, led by California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT06846320 about?
NCT06846320 is a clinical study titled "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 wi...
What is the current status of trial NCT06846320?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 315 participants. The study started on 2025-04-29. Estimated completion is 2026-11.
What conditions does trial NCT06846320 study?
This clinical trial studies the following conditions: Generalized Anxiety Disorder (GAD).
What interventions are being tested in trial NCT06846320?
The interventions under investigation include: ABBV-932 (DRUG), Placebo for ABBV-932 (DRUG), Antidepressant Therapy (ADT) (DRUG).
Who is sponsoring clinical trial NCT06846320?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06846320 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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