Actively Recruiting

Phase 2
Age: 18Years - 80Years
All Genders
NCT07002034

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

Led by Reunion Neuroscience Inc · Updated on 2026-05-06

100

Participants Needed

28

Research Sites

69 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Has had Adjustment Disorder for at least 4 weeks with depressed mood or mixed anxiety and depression triggered by cancer, ALS, MS, Parkinson's Disease, or IPF
  • Is ambulatory and able to care for self to complete study procedures
  • Has normal cognitive function
  • Is on stable antidepressant or psychotherapy treatment, or willing to delay such treatments until study end
  • If female, is not pregnant or planning pregnancy; if male, is not planning to father a child
  • Is willing and able to follow study requirements
Not Eligible

You will not qualify if you...

  • Has a significant risk of suicide
  • Has current or past bipolar disorder, schizophrenia, schizoaffective disorder, psychotic disorder, borderline personality disorder, or a first-degree family history of psychosis or bipolar disorder
  • Has active or past central nervous system cancer
  • Has other serious medical conditions that make participation unsuitable
  • Has used or needs to use prohibited medications or therapies
  • Has known allergy or intolerance to the study drug or rescue medications

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 28 locations

1

UAB, Psychiatry and Behavioral Neurology

Birmingham, Alabama, United States, 35209

Actively Recruiting

2

University of Arizona

Tucson, Arizona, United States, 85724

Actively Recruiting

3

Kadima Neuropsychiatry Institute

San Diego, California, United States, 92037

Actively Recruiting

4

Providence Medical Foundation

Santa Rosa, California, United States, 95403

Actively Recruiting

5

University of Colorado

Aurora, Colorado, United States, 80045

Actively Recruiting

6

University of South Florida, Department of Psychiatry and Behavioral Neuroscience

Tampa, Florida, United States, 33613

Actively Recruiting

7

Emory University

Atlanta, Georgia, United States, 30329

Actively Recruiting

8

Hawaii Pacific Neuroscience

Honolulu, Hawaii, United States, 96817

Actively Recruiting

9

Rush University Medical Center

Chicago, Illinois, United States, 60612

Actively Recruiting

10

The University of Kansas Medical Center

Kansas City, Kansas, United States, 66160

Actively Recruiting

11

LSU Health Shreveport

Shreveport, Louisiana, United States, 71103

Actively Recruiting

12

Sunstone Therapies, PC

Rockville, Maryland, United States, 20850

Actively Recruiting

13

Sheppard Pratt

Towson, Maryland, United States, 21204

Actively Recruiting

14

Dana Farber Cancer Institute

Boston, Massachusetts, United States, 02215

Actively Recruiting

15

University of Michigan

Ann Arbor, Michigan, United States, 48109

Actively Recruiting

16

Henry Ford Health

Novi, Michigan, United States, 48377

Actively Recruiting

17

University of Nebraska Medical Center

Omaha, Nebraska, United States, 68198

Actively Recruiting

18

University of New Mexico, School of Medicine

Albuquerque, New Mexico, United States, 87131

Actively Recruiting

19

NYU Langone Center for Psychedelic Medicine

New York, New York, United States, 10016

Actively Recruiting

20

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States, 27514

Actively Recruiting

21

Cleveland Clinic

Cleveland, Ohio, United States, 44113

Actively Recruiting

22

The Ohio State University, Department of Psychiatry

Columbus, Ohio, United States, 43210

Actively Recruiting

23

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

24

Alliance for Multispecialty Research Clinical

Knoxville, Tennessee, United States, 37920

Actively Recruiting

25

Dell Medical School, University of Texas at Austin

Austin, Texas, United States, 78712

Actively Recruiting

26

Cedar Clinical Research Inc.

Draper, Utah, United States, 84020

Actively Recruiting

27

UVA Center for Psychiatric Clinical Research

Charlottesville, Virginia, United States, 22903

Actively Recruiting

28

Seattle Neuropsychiatric Treatment Center

Seattle, Washington, United States, 98104

Actively Recruiting

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Research Team

M

Mark Pollack, Chief Medical Officer

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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