Assessing the safety and effectiveness of ABBV-932 for anxiety treatment
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
PHASE2 · AbbVie · NCT06846320
This study is testing a new drug called ABBV-932 to see if it can help adults with generalized anxiety disorder who aren't feeling better with their current antidepressants.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 315 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | AbbVie (industry) |
| Locations | 52 sites (Huntsville, Alabama and 51 other locations) |
| Trial ID | NCT06846320 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and efficacy of ABBV-932, an investigational drug, when added to existing antidepressant therapies in adults with generalized anxiety disorder (GAD) who have not responded adequately to their current treatment. Participants will be randomly assigned to receive either ABBV-932 or a placebo alongside their prescribed antidepressants for a duration of 6 weeks, followed by a 4-week follow-up period. The study aims to enroll approximately 315 participants across 50 sites in the United States and Puerto Rico.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with generalized anxiety disorder who are currently on FDA-approved antidepressant therapies but have experienced inadequate relief.
Not a fit: Patients with significant depression or those who have recently been diagnosed with major depression may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new adjunctive treatment option for patients with GAD who do not respond adequately to standard antidepressant therapies.
How similar studies have performed: Previous studies have explored adjunctive treatments for GAD, but the specific use of ABBV-932 in this context is novel.
Eligibility criteria
Show full inclusion / exclusion 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 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. Exclusion Criteria: * Have a Montgomery-Åsberg Depression Rating Scale (MADRS) score \>= 20. * New diagnosis or exacerbation of major depression in the last 6 months.
Where this trial is running
Huntsville, Alabama and 51 other locations
- University of Alabama - Huntsville Regional Medical Campus /ID# 267818 — Huntsville, Alabama, United States (RECRUITING)
- Ima Clinical Research Phoenix (Alea) /ID# 275737 — Phoenix, Arizona, United States (RECRUITING)
- Noble Clinical Research /ID# 267952 — Tucson, Arizona, United States (COMPLETED)
- Advanced Research Center /ID# 267874 — Anaheim, California, United States (RECRUITING)
- Axiom Research /ID# 267814 — Colton, California, United States (RECRUITING)
- Sun Valley Research Center /ID# 267864 — Imperial, California, United States (RECRUITING)
- Synergy San Diego /ID# 267879 — Lemon Grove, California, United States (RECRUITING)
- Alliance for Research Alliance for Wellness /ID# 267911 — Long Beach, California, United States (RECRUITING)
- NRC Research Institute DTLA /ID# 267832 — Los Angeles, California, United States (RECRUITING)
- Excell Research /ID# 267918 — Oceanside, California, United States (RECRUITING)
- Viking Clinical Research Center - Temecula /ID# 268598 — Temecula, California, United States (RECRUITING)
- Sunwise Clinical Research /ID# 267863 — Walnut Creek, California, United States (RECRUITING)
- Connecticut Clinical Research - Cromwell /ID# 271241 — Cromwell, Connecticut, United States (RECRUITING)
- Cns Healthcare - Jacksonville /ID# 268588 — Jacksonville, Florida, United States (RECRUITING)
- Accel Research Sites Network - St. Pete /ID# 267821 — Largo, Florida, United States (RECRUITING)
- K2 Medical Research, LLC /ID# 267841 — Maitland, Florida, United States (RECRUITING)
- GMI Florida - Central Miami Medical Institute /ID# 267839 — Miami, Florida, United States (RECRUITING)
- Allied Biomedical Res Inst Inc /ID# 267813 — Miami, Florida, United States (RECRUITING)
- Apg Research /ID# 271707 — Orlando, Florida, United States (RECRUITING)
- Psych Atlanta /ID# 267878 — Marietta, Georgia, United States (RECRUITING)
- iResearch Savannah /ID# 267865 — Savannah, Georgia, United States (RECRUITING)
- University of Chicago Medical Center /ID# 275131 — Chicago, Illinois, United States (RECRUITING)
- Collective Medical Research /ID# 272015 — Overland Park, Kansas, United States (RECRUITING)
- CenExel /ID# 267853 — Gaithersburg, Maryland, United States (RECRUITING)
- Elixia, LLC /ID# 267815 — Springfield, Massachusetts, United States (RECRUITING)
- Psychiatric Care And Research Center /ID# 271701 — O'Fallon, Missouri, United States (RECRUITING)
- St. Charles Psychiatric Associates /ID# 271202 — Saint Charles, Missouri, United States (RECRUITING)
- Arch Clinical Trials /ID# 267851 — St Louis, Missouri, United States (RECRUITING)
- Ima Clinical Research Las Vegas (Altea) /ID# 275731 — Las Vegas, Nevada, United States (RECRUITING)
- Duplicate_Oasis Clinical Research, LLC /ID# 267953 — Las Vegas, Nevada, United States (COMPLETED)
- Princeton Medical Institute /ID# 267877 — Princeton, New Jersey, United States (RECRUITING)
- Bio Behavioral Health /ID# 267919 — Toms River, New Jersey, United States (RECRUITING)
- Integrative Clinical Trials /ID# 279519 — Brooklyn, New York, United States (RECRUITING)
- New Hope Clinical Research - Inpatient unit /ID# 267810 — Charlotte, North Carolina, United States (RECRUITING)
- Quest Therapeutics of Avon /ID# 267829 — Avon Lake, Ohio, United States (RECRUITING)
- University Of Cincinnati Medical Center /ID# 271704 — Cincinnati, Ohio, United States (RECRUITING)
- The Ohio State University /ID# 267924 — Columbus, Ohio, United States (RECRUITING)
- Sooner Clinical Research /ID# 267881 — Oklahoma City, Oklahoma, United States (RECRUITING)
- Lehigh Center for Clinical Research /ID# 267908 — Allentown, Pennsylvania, United States (RECRUITING)
- Suburban Research Associates /ID# 267868 — West Chester, Pennsylvania, United States (RECRUITING)
- Coastal Carolina Research Center, LLC /ID# 267826 — Charleston, South Carolina, United States (RECRUITING)
- Psychiatric Consultants - Franklin /ID# 275133 — Franklin, Tennessee, United States (RECRUITING)
- FutureSearch Trials of Dallas /ID# 267870 — Dallas, Texas, United States (RECRUITING)
- Relaro Medical Trials /ID# 270241 — Dallas, Texas, United States (RECRUITING)
- Perceptive Pharma Research /ID# 267836 — Richmond, Texas, United States (RECRUITING)
- Family Psychiatry Of The Woodlands /ID# 275173 — The Woodlands, Texas, United States (RECRUITING)
- Grayline Research Center /ID# 267811 — Wichita Falls, Texas, United States (RECRUITING)
- Northwest Clinical Research Center /ID# 267916 — Bellevue, Washington, United States (RECRUITING)
- Core Clinical Research /ID# 270058 — Everett, Washington, United States (RECRUITING)
- INSPIRA Clinical Research /ID# 267822 — San Juan, Puerto Rico (RECRUITING)
+2 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: ABBVIE CALL CENTER
- Email: abbvieclinicaltrials@abbvie.com
- Phone: 844-663-3742
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Generalized Anxiety Disorder, LEGATO -, ABBV-932