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RE104 Safety and Efficacy Study in Generalized Anxiety Disorder

NCT ID: NCT07489651
Registry status: Recruiting
Study type: Interventional
Phase: Phase 2
Sponsor: Reunion Neuroscience Inc
Conditions: Generalized Anxiety Disorder

Overview

ClinicalTrials.gov lists this study as Recruiting.

Official title: A Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of RE104 for Injection in the Treatment of Generalized Anxiety Disorder

Enrollment: 160 participants (Estimated).

What is being studied

Intervention: Drug Administration Routes
Intervention: Drug Therapy
Intervention: Injections
Drug: Placebo
Drug: RE104 for Injection
Intervention: Therapeutics

Who may be eligible

Ages: 18 Years to 74 Years
Sex: All
Healthy volunteers accepted: No

ClinicalTrials.gov lists the following eligibility criteria.

Inclusion Criteria: * 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 Exclusion Criteria: * Has a significant risk of suicide * Has an active or medical history of bipolar disorder, schizophrenia, schizoaffective disorder, psychotic disorder and/or borderline personality disorder, or first-degree family history of psychosis or bipolar disorder * Has other concurrent psychiatric disorders that is the primary disorder. * Has other medically significant conditions rendering unsuitability for the study * Has used or will need to use prohibited medications or therapies * Has a known sensitivity or intolerance to study intervention or potential rescue medications

Study locations

28 study locations are listed.

Recruiting site status is explicitly provided for 28 locations; 27 are listed as Recruiting.

Countries: United States

Alabama, United States: 1
Arizona, United States: 1
Arkansas, United States: 1
California, United States: 4
Florida, United States: 2
Georgia, United States: 4
Illinois, United States: 1
Michigan, United States: 1
Missouri, United States: 1
New Mexico, United States: 1
New York, United States: 1
North Carolina, United States: 1
Ohio, United States: 1
Oregon, United States: 1
Pennsylvania, United States: 2
Texas, United States: 3
Utah, United States: 2

Sample of listed locations

University of Alabama (UAB) Clinical Research Unit (CRU) — Birmingham, Alabama, 35209, United States — Recruiting
Lighthouse Psychiatry — Gilbert, Arizona, 85234, United States — Recruiting
Preferred Research Partners, Inc. — Little Rock, Arkansas, 72211, United States — Recruiting
Collaborative Neuroscience Research, LLC — Garden Grove, California, 92845, United States — Recruiting
Kadima Neuropsychiatry Institute — La Jolla, California, 92037, United States — Recruiting
Open Mind Therapeutics — San Francisco, California, 94114, United States — Recruiting
TRIP Clinic at Psychedelic Science Institute — Santa Monica, California, 90404, United States — Recruiting
Innovative Clinical Research, Inc. — Lauderhill, Florida, 33319, United States — Recruiting
University of South Florida — Tampa, Florida, 33613, United States — Recruiting
Atlanta Center for Medical Research — Atlanta, Georgia, 30331, United States — Recruiting
CenExel iResearch, LLC — Decatur, Georgia, 30030, United States — Recruiting
Evergreen Clinical Trials — Norcross, Georgia, 30092, United States — Recruiting
CenExel iResearch, LLC — Savannah, Georgia, 31405, United States — Recruiting
Uptown Research Institute — Chicago, Illinois, 60640, United States — Recruiting
Henry Ford Medical Center - Columbus — Novi, Michigan, 48377, United States — Recruiting
Midwest Research Group — Saint Charles, Missouri, 63304, United States — Recruiting
UNM Research Program Psychedelic Therapies — Albuquerque, New Mexico, 14624, United States — Recruiting
NYU-H+C Clinical and Translational Science Institute — New York, New York, 10016, United States — Recruiting
University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, 27514, United States — Recruiting
Neuro-Behavioral Clinical Research, Inc. — North Canton, Ohio, 44720, United States — Recruiting
Summit Headlands LLC — Portland, Oregon, 97210, United States — Recruiting
University of Pennsylvania — Philadelphia, Pennsylvania, 19104, United States — Recruiting
Austin Clinical Trial Partners — Austin, Texas, 78737, United States — Recruiting
BioBehavioral Research Austion — Austin, Texas, 78759, United States — Recruiting
Aim Trials, LLC — Plano, Texas, 75093, United States — Recruiting

Study details

Start date: April 20, 2026
Primary completion date: July 1, 2027
Completion date: September 1, 2027
First posted: March 24, 2026

Source and update information

Source: ClinicalTrials.gov
NCT ID: NCT07489651
Registry last updated: September 24, 2026
QualifiedStudies registry data refreshed: September 28, 2026
QualifiedStudies record fetched: September 28, 2026

View NCT07489651 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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