RE104 Safety and Efficacy Study in Generalized Anxiety Disorder

Part of paid clinical trials in Gilbert, Arizona.

Sponsor
Reunion Neuroscience Inc
Study ID
NCT07489651
Phase
PHASE2
Status
Recruiting

Conditions

  • Generalized Anxiety Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - 74 Years
Healthy Volunteers
Not accepted

Interventions

  • RE104 for Injection — DRUG
    Single, subcutaneous dose of RE104 for Injection
  • Placebo — DRUG
    Single, subcutaneous dose of 0.9% sodium chloride for injection

Study Details

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 Dates

Start date
Apr 20, 2026
Status verified
May 2026
Primary completion
Feb 28, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
64 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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

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

Locations (12)

FacilityCityStateZIPSite coordinators
Lighthouse PsychiatryGilbertArizona85234
Matt Longson
435-268-5800
Open Mind TherapeuticsSan FranciscoCalifornia94114
Victoria Vega
415-906-7399
TRIP Clinic at Psychedelic Science InstituteSanta MonicaCalifornia90404
Ashley Ramos
University of South FloridaTampaFlorida33613
Genesis Estramera
813-974-1404
Atlanta Center for Medical ResearchAtlantaGeorgia30331
Amber Tannahill
404-881-5800
CenExel iResearch, LLCDecaturGeorgia30030
Michael Mahaffrey
UNM Research Program Psychedelic TherapiesAlbuquerqueNew Mexico14624
Hector Garcia
505-675-0582
Summit Headlands LLCPortlandOregon97210
Tyler Leecing
Austin Clinical Trial PartnersAustinTexas78737
Kara Chilek
512-521-0595
Aim Trials, LLCPlanoTexas75093
Sonia Prashar
214-856-2778
Cedar Clinical ResearchDraperUtah84020
Jane Bjorklund
801-369-4219
Inner Space State StreetOremUtah84058
Janet Jimenez
801-871-5516

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