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Taking people in United StatesPhase 2

RE104 Safety and Efficacy Study in Generalized Anxiety Disorder

Key facts

Who runs it
Reunion Neuroscience Inc
Where
Albuquerque, Atlanta, Austin, Birmingham, Chapel Hill, Chicago, Decatur, Draper, Garden Grove, Gilbert, La Jolla, Lauderhill, Little Rock, New York, Norcross, North Canton, Novi, Orem, Philadelphia, Plano, Portland, Saint Charles, San Francisco, Santa Monica, Savannah, Tampa, and West Chester, United StatesSee the 28 sites
Trial code
Status
Recruiting
Phase
Phase 2
People taking part
160 people, planned
Started
20 Apr 2026
Expected to end
Sept 2027
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • RE104 for Injection
  • Placebo
Record updated
24 September 2026

Who can take part

Age
18 years to 74 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 9 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Has other concurrent psychiatric disorders that is the primary disorder
  • Has used or will need to use prohibited medications or therapies
  • Has a known sensitivity or intolerance to study intervention or potential rescue medications
  • 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 medically significant conditions rendering unsuitability for the study
  • Has a significant risk of suicide

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 74 years old?

Where in United States

  • UNM Research Program Psychedelic TherapiesAlbuquerque, United StatesContact: Hector GarciaTaking people
  • Atlanta Center for Medical ResearchAtlanta, United StatesContact: Amber TannahillTaking people
  • Austin Clinical Trial PartnersAustin, United StatesContact: Kara ChilekTaking people
  • BioBehavioral Research AustionAustin, United StatesContact: Tracie WessonTaking people
  • University of Alabama (UAB) Clinical Research Unit (CRU)Birmingham, United StatesContact: Seher PremaniTaking people
  • University of North Carolina at Chapel HillChapel Hill, United StatesContact: Julia HoffmanTaking people
  • Uptown Research InstituteChicago, United StatesContact: Deborah Jones-MillerTaking people
  • CenExel iResearch, LLCDecatur, United StatesContact: Michael MahaffreyTaking people
  • Cedar Clinical ResearchDraper, United StatesContact: Jane BjorklundTaking people
  • Collaborative NeuroScience Research , LLCGarden Grove, United StatesContact: CNS Outreach DepartmentTaking people
  • Lighthouse PsychiatryGilbert, United StatesContact: Matt LongsonTaking people
  • Kadima Neuropsychiatry InstituteLa Jolla, United StatesContact: Angelica LuTaking people
  • Innovative Clinical Research, Inc.Lauderhill, United StatesContact: Melissa RodcoTaking people
  • Preferred Research Partners, IncLittle Rock, United StatesContact: Stacy TierneyTaking people
  • NYU-H+C Clinical and Translational Science InstituteNew York, United StatesContact: Jillian KellyTaking people
  • Evergreen Clinical TrialsNorcross, United StatesContact: Stephen WheelerTaking people
  • Neuro-Behavioral Clinical Research Inc.North Canton, United StatesContact: Crystal BlackfordTaking people
  • Henry Ford Medical Center-ColumbusNovi, United StatesContact: Madeline BrossTaking people
  • Inner Space State StreetOrem, United StatesContact: Janet JimenezTaking people
  • University of PennsylvaniaPhiladelphia, United StatesContact: Erin BlaseTaking people
  • Aim Trials, LLCPlano, United StatesContact: Sonia PrasharTaking people
  • Summit Headlands LLCPortland, United StatesContact: Tyler LeecingTaking people
  • Midwest Research GroupSaint Charles, United StatesContact: Lindsay vanWinkleTaking people
  • Open Mind TherapeuticsSan Francisco, United StatesContact: Victoria VegaTaking people
  • TRIP Clinic at Psychedelic Science InstituteSanta Monica, United StatesContact: Ashley RamosTaking people
  • CenExel iResearch, LLCSavannah, United StatesContact: Michelle LagaresTaking people
  • University of South FloridaTampa, United StatesContact: Genesis EstrameraTaking people
  • Suburban Research AssociatesWest Chester, United StatesContact: Mark Pollack Chief Medical Officer, M.D.No longer taking part

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • PlaceboPlacebo, for comparison

    A single subcutaneous injection of 0.9% sodium chloride for injection per dosing session

  • 30 mg RE104Treatment being tested

    A single subcutaneous injection of 30 mg RE104 for Injection per dosing session

    Treatment: RE104 for Injection

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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
Fit questions
Built from NCT07489651, who can take part
Record updated
24 September 2026
RE104 Safety and Efficacy Study in Generalized Anxiety Disorder (NCT07489651) – Frontlight Research