Clinical TrialParallelAnxiety DisordersPlaceboPsilocybinRecruiting

RE104 Safety and Efficacy Study in Generalized Anxiety Disorder

This Phase II, randomised, triple-blind, placebo-controlled trial (n=64) is evaluating a single subcutaneous dose of RE104 in adults with generalised anxiety disorder. Participants receive either 30 mg RE104 or a matching injection of 0.9% sodium chloride placebo in a parallel-group design. The primary outcome is change from baseline in Hamilton Anxiety Rating Scale total score at Week 4. The study also evaluates treatment-emergent adverse events and other measures of anxiety, mood and functioning during the follow-up period.

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Target Enrollment
64 participants
Study Type
Phase II interventional
Design
Randomized, triple Blind

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Compound research: PlaceboTopic research: Anxiety DisordersResearch in United States

Detailed Description

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.

Study Arms & Interventions

Placebo (matched to psilocybin 30 mg)

inactive

A single subcutaneous injection of 0.9% sodium chloride for injection

Interventions

  • Placebo
    via Subcutaneous• single dose• 1 doses total

    0.9% sodium chloride placebo.

Psilocybin 30 mg

experimental

A single subcutaneous injection of 30 mg RE104 for Injection

Interventions

  • Psilocybin30 mg
    via Subcutaneous• single dose• 1 doses total

    Luvesilocin (RE104); represented under Blossom’s Psilocybin compound record.

Participants

Ages
18 – 74
Sexes
Male & Female

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 Protocol, Arms & Participants

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Study Details

  • Status
    Recruiting
  • Phase
    Phase II
  • Type
    interventional
  • Design
    Randomizedtriple Blind
  • Target Enrollment64 participants
  • Timeline
    Start: 2026-04-20
    End: 2027-04-01
  • Compounds
    PlaceboPsilocybin
  • Topic
    Anxiety Disorders

Study Team

Sponsors & Collaborators

Locations

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

Recent activity

  • StartedRE104 Safety and Efficacy Study in Generalized Anxiety Disorder (NCT07489651, psilocybin)

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