A Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of RE104 for Injection in the Treatment of Generalized Anxiety Disorder
Status: Recruiting
Location: See all (28) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
The purpose of this study is to determine if treatment with a single dose of RE104 for Injection reduces anxiety symptoms in participants with Generalized Anxiety Disorder (GAD) as compared to placebo.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 74
Healthy Volunteers: f
View:
• Has Generalized Anxiety Disorder as defined by DSM-5-TR
• If female is not pregnant or planning to become pregnant. If male is not planning to make a partner pregnant.
• Is willing and able to comply with the conditions and requirements of the study
Locations
United States
Alabama
University of Alabama (UAB) Clinical Research Unit (CRU)
RECRUITING
Birmingham
Arkansas
Preferred Research Partners, Inc.
RECRUITING
Little Rock
Arizona
Lighthouse Psychiatry
RECRUITING
Gilbert
California
Collaborative Neuroscience Research, LLC
RECRUITING
Garden Grove
Kadima Neuropsychiatry Institute
RECRUITING
La Jolla
Open Mind Therapeutics
RECRUITING
San Francisco
TRIP Clinic at Psychedelic Science Institute
RECRUITING
Santa Monica
Florida
Innovative Clinical Research, Inc.
RECRUITING
Lauderhill
University of South Florida
RECRUITING
Tampa
Georgia
Atlanta Center for Medical Research
RECRUITING
Atlanta
CenExel iResearch, LLC
RECRUITING
Decatur
Evergreen Clinical Trials
RECRUITING
Norcross
CenExel iResearch, LLC
RECRUITING
Savannah
Illinois
Uptown Research Institute
RECRUITING
Chicago
Michigan
Henry Ford Medical Center - Columbus
RECRUITING
Novi
Missouri
Midwest Research Group
RECRUITING
Saint Charles
North Carolina
University of North Carolina at Chapel Hill
RECRUITING
Chapel Hill
New Mexico
UNM Research Program Psychedelic Therapies
RECRUITING
Albuquerque
New York
NYU-H+C Clinical and Translational Science Institute
RECRUITING
New York
Ohio
Neuro-Behavioral Clinical Research, Inc.
RECRUITING
North Canton
Oregon
Summit Headlands LLC
RECRUITING
Portland
Pennsylvania
University of Pennsylvania
RECRUITING
Philadelphia
Suburban Research Associates
RECRUITING
West Chester
Texas
Austin Clinical Trial Partners
RECRUITING
Austin
BioBehavioral Research Austion
RECRUITING
Austin
Aim Trials, LLC
RECRUITING
Plano
Utah
Cedar Clinical Research
RECRUITING
Draper
Inner Space State Street
RECRUITING
Orem
Contact Information
Primary
Mark Pollack Chief Medical Officer, M.D.
info@reunionneuro.com
1-888-880-REUN
Time Frame
Start Date: 2026-04-20
Estimated Completion Date: 2027-04
Participants
Target number of participants: 64
Treatments
Placebo_comparator: Placebo
A single subcutaneous injection of 0.9% sodium chloride for injection
Experimental: 30 mg RE104
A single subcutaneous injection of 30 mg RE104 for Injection
Related Therapeutic Areas
Sponsors
Leads: Reunion Neuroscience Inc