NCT07489651From ClinicalTrials.govRecruiting

RE104 Safety and Efficacy Study in Generalized Anxiety Disorder

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

Generalized Anxiety Disorder

At a glance

Phase: Phase 2
Study type: Interventional
Sponsor: Reunion Neuroscience Inc
Enrolment target: 160
Started: 20 April 2026
Main results due: July 2027
Study sites: 28
Registry updated: 24 September 2026

Can you take part?

Ages 18 years to 74 years.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full 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

What this study is about

In the sponsor’s own words, from the registry.

The purpose of this study is to determine if treatment with a single and/or repeat dose of RE104 for Injection reduces anxiety symptoms in participants with Generalized Anxiety Disorder (GAD) as compared to placebo.

Study sites(28)

University of Alabama (UAB) Clinical Research Unit (CRU)
Birmingham, Alabama, United States
Recruiting
Lighthouse Psychiatry
Gilbert, Arizona, United States
Recruiting
Preferred Research Partners, Inc.
Little Rock, Arkansas, United States
Recruiting
Collaborative Neuroscience Research, LLC
Garden Grove, California, United States
Recruiting
Kadima Neuropsychiatry Institute
La Jolla, California, United States
Recruiting
Open Mind Therapeutics
San Francisco, California, United States
Recruiting
TRIP Clinic at Psychedelic Science Institute
Santa Monica, California, United States
Recruiting
Innovative Clinical Research, Inc.
Lauderhill, Florida, United States
Recruiting
University of South Florida
Tampa, Florida, United States
Recruiting
Atlanta Center for Medical Research
Atlanta, Georgia, United States
Recruiting
CenExel iResearch, LLC
Decatur, Georgia, United States
Recruiting
Evergreen Clinical Trials
Norcross, Georgia, United States
Recruiting
CenExel iResearch, LLC
Savannah, Georgia, United States
Recruiting
Uptown Research Institute
Chicago, Illinois, United States
Recruiting
Henry Ford Medical Center - Columbus
Novi, Michigan, United States
Recruiting
Midwest Research Group
Saint Charles, Missouri, United States
Recruiting
UNM Research Program Psychedelic Therapies
Albuquerque, New Mexico, United States
Recruiting
NYU-H+C Clinical and Translational Science Institute
New York, New York, United States
Recruiting
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Recruiting
Neuro-Behavioral Clinical Research, Inc.
North Canton, Ohio, United States
Recruiting
Summit Headlands LLC
Portland, Oregon, United States
Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Recruiting
Suburban Research Associates
West Chester, Pennsylvania, United States
Withdrawn
Austin Clinical Trial Partners
Austin, Texas, United States
Recruiting
BioBehavioral Research Austion
Austin, Texas, United States
Recruiting
Aim Trials, LLC
Plano, Texas, United States
Recruiting
Cedar Clinical Research
Draper, Utah, United States
Recruiting
Inner Space State Street
Orem, Utah, United States
Recruiting

Showing 28 of 28 sites. 27 of the 28 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07489651. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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