RecruitingPhase 2NCT07002034

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

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

Sponsor

Reunion Neuroscience Inc

Enrollment

100 participants

Start Date

Jul 30, 2025

Study Type

INTERVENTIONAL

Conditions

Adjustment Disorder

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called RE104 for people who are experiencing adjustment disorder — significant emotional distress, including depression or anxiety, triggered by a serious medical diagnosis such as cancer, ALS, MS, Parkinson's disease, or pulmonary fibrosis. **You may be eligible if...** - You have had adjustment disorder with depressed or mixed mood for at least 4 weeks, caused by your medical illness - Your disorder was triggered by a diagnosis of cancer, ALS, MS, Parkinson's disease, or idiopathic pulmonary fibrosis - You have normal cognitive function and are physically able to participate - You are stable on (or not currently taking) antidepressants or psychotherapy - You are not pregnant and do not plan to become pregnant during the study **You may NOT be eligible if...** - You have a significant suicide risk - You have bipolar disorder, schizophrenia, psychosis, or borderline personality disorder - You have a first-degree family member with psychosis or bipolar disorder - You have CNS cancer or other major medical conditions making participation unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRE104 for Injection

Single, subcutaneous dose of RE104 for Injection

Locations(26)

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

University of Michigan

Ann Arbor, Michigan, 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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT07002034

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