NCT07489651

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for phase_2

Timeline
11mo left

Started Apr 2026

Shorter than P25 for phase_2

Geographic Reach
1 country

28 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress33%
Apr 2026Sep 2027

First Submitted

Initial submission to the registry

March 18, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 24, 2026

Completed
27 days until next milestone

Study Start

First participant enrolled

April 20, 2026

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

September 24, 2026

Status Verified

September 1, 2026

Enrollment Period

1.2 years

First QC Date

March 18, 2026

Last Update Submit

September 21, 2026

Conditions

Generalized Anxiety Disorder

Keywords

GAD

Outcome Measures

Primary Outcomes (1)

  • RE104 when administered as a single 30 mg dose or as two 30 mg doses 3 weeks apart versus placebo change from Baseline at Week 4 in Hamilton Anxiety Rating Scale (HAM-A) total score

    The Hamilton Rating Scale for Anxiety (HAM-A) is a 14-item scale that is used to rate the severity of symptoms of anxiety. The total score ranges from 0-56 with higher scores representing greater severity of anxiety.

    Week 4

Secondary Outcomes (6)

  • RE104 versus placebo changes in total score from baseline in Hamilton Anxiety Rating Scale (HAM-A)

    Weeks 1, 2, 8 and 12

  • RE104 versus placebo percentage of participants with HAM-A response (≥50% reduction in score from Baseline)

    Weeks 1, 2, 4, 8 and 12

  • RE104 versus placebo percentage of participants with HAM-A remission (total score ≤7)

    Day 1 and Weeks 1, 2, 4, 8 and 12

  • RE104 versus placebo change from Baseline at Weeks 1, 2, 4, 8, and 12 in Hospital Anxiety and Depression Scale (HADS) depression subscore

    Weeks 1, 2, 4, 8 and 12

  • RE104 versus placebo incidence of treatment-emergent adverse events (TEAEs) by frequency, severity and seriousness.

    From dosing through study completion (post-dose follow-up is for 12 weeks)

  • +1 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

30 mg RE104

EXPERIMENTAL

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

Drug: RE104 for Injection

Interventions

RE104 for InjectionDRUG

Single dose (Part A) or Repeat-dose (Part B), subcutaneous injection(s) of RE104 for Injection

30 mg RE104
PlaceboDRUG

Single-dose (Part A) or Repeat-dose (Part B), subcutaneous injection(s) of 0.9% sodium chloride for injection

Placebo

Eligibility Criteria

Age18 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (28)

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

Birmingham, Alabama, 35209, United States

RECRUITING

Lighthouse Psychiatry

Gilbert, Arizona, 85234, United States

RECRUITING

Preferred Research Partners, Inc.

Little Rock, Arkansas, 72211, United States

RECRUITING

Collaborative Neuroscience Research, LLC

Garden Grove, California, 92845, United States

RECRUITING

Kadima Neuropsychiatry Institute

La Jolla, California, 92037, United States

RECRUITING

Open Mind Therapeutics

San Francisco, California, 94114, United States

RECRUITING

TRIP Clinic at Psychedelic Science Institute

Santa Monica, California, 90404, United States

RECRUITING

Innovative Clinical Research, Inc.

Lauderhill, Florida, 33319, United States

RECRUITING

University of South Florida

Tampa, Florida, 33613, United States

RECRUITING

Atlanta Center for Medical Research

Atlanta, Georgia, 30331, United States

RECRUITING

CenExel iResearch, LLC

Decatur, Georgia, 30030, United States

RECRUITING

Evergreen Clinical Trials

Norcross, Georgia, 30092, United States

RECRUITING

CenExel iResearch, LLC

Savannah, Georgia, 31405, United States

RECRUITING

Uptown Research Institute

Chicago, Illinois, 60640, United States

RECRUITING

Henry Ford Medical Center - Columbus

Novi, Michigan, 48377, United States

RECRUITING

Midwest Research Group

Saint Charles, Missouri, 63304, United States

RECRUITING

UNM Research Program Psychedelic Therapies

Albuquerque, New Mexico, 14624, United States

RECRUITING

NYU-H+C Clinical and Translational Science Institute

New York, New York, 10016, United States

RECRUITING

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27514, United States

RECRUITING

Neuro-Behavioral Clinical Research, Inc.

North Canton, Ohio, 44720, United States

RECRUITING

Summit Headlands LLC

Portland, Oregon, 97210, United States

RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Suburban Research Associates

West Chester, Pennsylvania, 19380, United States

WITHDRAWN

Austin Clinical Trial Partners

Austin, Texas, 78737, United States

RECRUITING

BioBehavioral Research Austion

Austin, Texas, 78759, United States

RECRUITING

Aim Trials, LLC

Plano, Texas, 75093, United States

RECRUITING

Cedar Clinical Research

Draper, Utah, 84020, United States

RECRUITING

Inner Space State Street

Orem, Utah, 84058, United States

RECRUITING

MeSH Terms

Conditions

Generalized Anxiety Disorder

Interventions

Injections

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Drug Administration RoutesDrug TherapyTherapeutics

Study Officials

  • Mark Pollack, M.D.

    Reunion Neuroscience Inc

    STUDY DIRECTOR

Central Study Contacts

Mark Pollack Chief Medical Officer, M.D.

CONTACT

1-888-880-REUNinfo@reunionneuro.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2026

First Posted

March 24, 2026

Study Start

April 20, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

September 24, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Data sharing will be consistent with the results submission policy of ClinicalTrials.gov.

Locations

US(28)