Recruiting
Phase 2

RE104

Sponsor:

Reunion Neuroscience Inc

Code:

NCT07489651

Conditions

Generalized Anxiety Disorder

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

RE104 for Injection

Placebo

Study Details

Brief 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.

Conditions

Generalized Anxiety Disorder

Study ID

NCT07489651

Start date

Apr 20, 2026

Status verified date

May, 2026

Completion date

Apr, 2027

Anticipated

Primary completion date

Feb, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

64 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

Interventions

RE104 for Injection

Single, subcutaneous dose of RE104 for Injection

Placebo

Single, subcutaneous dose of 0.9% sodium chloride for injection

Primary outcome measure

  • RE104 30 mg versus placebo change from Baseline at Week 4 in Hamilton Anxiety Rating Scale (HAM-A) total score [ Time Frame: Week 4 ]

Central Contacts and Locations

Central contacts

Mark Pollack Chief Medical Officer, M.D.

1-888-880-REUNinfo@reunionneuro.com

Locations

University of Alabama (UAB) Clinical Research Unit (CRU)

Recruiting

Birmingham, Alabama, United States, 35209

Contacts

Lighthouse Psychiatry

Recruiting

Gilbert, Arizona, United States, 85234

Contacts

Preferred Research Partners, Inc.

Recruiting

Little Rock, Arkansas, United States, 72211

Contacts

Collaborative Neuroscience Research, LLC

Recruiting

Garden Grove, California, United States, 92845

Contacts

Kadima Neuropsychiatry Institute

Recruiting

La Jolla, California, United States, 92037

Contacts

Open Mind Therapeutics

Recruiting

San Francisco, California, United States, 94114

Contacts

TRIP Clinic at Psychedelic Science Institute

Recruiting

Santa Monica, California, United States, 90404

Contacts

Innovative Clinical Research, Inc.

Recruiting

Lauderhill, Florida, United States, 33319

Contacts

University of South Florida

Recruiting

Tampa, Florida, United States, 33613

Contacts

Atlanta Center for Medical Research

Recruiting

Atlanta, Georgia, United States, 30331

Contacts

CenExel iResearch, LLC

Recruiting

Decatur, Georgia, United States, 30030

Contacts

Michael Mahaffrey

m.mahaffrey@cenexel.com

Evergreen Clinical Trials

Recruiting

Norcross, Georgia, United States, 30092

Contacts

CenExel iResearch, LLC

Recruiting

Savannah, Georgia, United States, 31405

Contacts

Uptown Research Institute

Recruiting

Chicago, Illinois, United States, 60640

Contacts

Henry Ford Medical Center - Columbus

Recruiting

Novi, Michigan, United States, 48377

Contacts

Midwest Research Group

Recruiting

Saint Charles, Missouri, United States, 63304

Contacts

UNM Research Program Psychedelic Therapies

Recruiting

Albuquerque, New Mexico, United States, 14624

Contacts

NYU-H+C Clinical and Translational Science Institute

Recruiting

New York, New York, United States, 10016

Contacts

University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27514

Contacts

Neuro-Behavioral Clinical Research, Inc.

Recruiting

North Canton, Ohio, United States, 44720

Contacts

Summit Headlands LLC

Recruiting

Portland, Oregon, United States, 97210

Contacts

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Suburban Research Associates

Recruiting

West Chester, Pennsylvania, United States, 19380

Contacts

Austin Clinical Trial Partners

Recruiting

Austin, Texas, United States, 78737

Contacts

BioBehavioral Research Austion

Recruiting

Austin, Texas, United States, 78759

Contacts

Aim Trials, LLC

Recruiting

Plano, Texas, United States, 75093

Contacts

Cedar Clinical Research

Recruiting

Draper, Utah, United States, 84020

Contacts

Inner Space State Street

Recruiting

Orem, Utah, United States, 84058

Contacts

More Information

Sponsor

Reunion Neuroscience Inc

Last update posted

Aug 18, 2026

Last verified

May, 2026

Keywords

  • GAD

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-05. This information was provided to ClinicalTrials.gov by Reunion Neuroscience Inc on 2026-08-18.