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RECRUITING
NCT07002034
PHASE2

RE104 Safety and Efficacy Study in Adjustment Disorder in Cancer and Other Medical Illnesses

Sponsor: Reunion Neuroscience Inc

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine if treatment with a single dose of RE104 for Injection reduces depressive symptoms or depressive symptoms mixed with anxiety symptoms in participants with Adjustment Disorder due to cancer or other illnesses such as Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), Parkinson's Disease (PD) or Idiopathic Pulmonary Fibrosis (IPF) as compared to active-placebo.

Official title: A Randomized, Double-Blind, Parallel-Group, Dose-Controlled Study Evaluating the Safety and Efficacy of RE104 for Injection in the Treatment of Adjustment Disorder in Patients With Cancer and Other Medical Illnesses

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2025-07-30

Completion Date

2026-12

Last Updated

2026-03-16

Healthy Volunteers

No

Interventions

DRUG

RE104 for Injection

Single, subcutaneous dose of RE104 for Injection

Locations (25)

UAB, Psychiatry and Behavioral Neurology

Birmingham, Alabama, United States

University of Arizona

Tucson, Arizona, United States

Kadima Neuropsychiatry Institute

San Diego, California, United States

Providence Medical Foundation

Santa Rosa, California, United States

University of Colorado

Aurora, Colorado, United States

University of South Florida, Department of Psychiatry and Behavioral Neuroscience

Tampa, Florida, United States

Emory University

Atlanta, Georgia, United States

Hawaii Pacific Neuroscience

Honolulu, Hawaii, United States

Rush University Medical Center

Chicago, Illinois, United States

LSU Health Shreveport

Shreveport, Louisiana, United States

Sunstone Therapies, PC

Rockville, Maryland, United States

Sheppard Pratt

Towson, Maryland, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Henry Ford Health

Novi, Michigan, United States

University of New Mexico, School of Medicine

Albuquerque, New Mexico, United States

NYU Langone Center for Psychedelic Medicine

New York, New York, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Cleveland Clinic

Cleveland, Ohio, United States

The Ohio State University, Department of Psychiatry

Columbus, Ohio, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Alliance for Multispecialty Research Clinical

Knoxville, Tennessee, United States

Dell Medical School, University of Texas at Austin

Austin, Texas, United States

Cedar Clinical Research Inc.

Draper, Utah, United States

UVA Center for Psychiatric Clinical Research

Charlottesville, Virginia, United States

Seattle Neuropsychiatric Treatment Center

Seattle, Washington, United States