RE104 Safety and Efficacy Study in Generalized Anxiety Disorder

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Generalized Anxiety Disorder

In brief

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.

Key facts

Study ID

NCT07489651

Run by

Reunion Neuroscience Inc

People needed

64

Starts

2026-04-20

Expected to finish

2027-04-01

Last updated by the study team

2026-06-26

Who can join

Age: 18 and older, up to 74. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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