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NCT07002034 | RECRUITING | Adjustment Disorder

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

Reunion Neuroscience Inc

Brief 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.

Condition or disease

Adjustment Disorder

Intervention/treatment

RE104 for Injection

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 100 participants
Masking : TRIPLE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2025-07-30
Estimated Primary Completion Date : 2026-11
Estimated Study Completion Date : 2026-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 80 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Has a ≥4 week history of AjD as defined by DSM-5-TR with either depressed mood, or mixed anxiety and depressed mood confirmed by clinical interview with evidence that the AjD was instigated by one of the following medical illnesses (e.g., diagnosis, impact, management, recurrence, prognosis): Cancer, ALS, MS, PD or IPF
  • * Is sufficiently ambulatory and capable of self care as necessary to complete study procedures
  • * Has normal cognitive function
  • * Is on stable use of antidepressants or psychotherapy, or is willing to delay use until the end of study
  • * 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
Exclusion Criteria
  • * Has a significant risk of suicide
  • * Has 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 active or a history of central nervous system malignancy
  • * 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
RE104 Safety and Efficacy Study in Adjustment Disorder in Cancer and Other Medical Illnesses

Location Details

NCT07002034

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, alabama

UAB, Psychiatry and Behavioral Neurology

Birmingham, alabama, United States, 35209

RECRUITING

United States, Arizona

University of Arizona

Tucson, arizona, United States, 85724

RECRUITING

United States, California

Kadima Neuropsychiatry Institute

San Diego, California, United States, 92037

RECRUITING

United States, California

Providence Medical Foundation

Santa Rosa, California, United States, 95403

RECRUITING

United States, Colorado

University of Colorado

Aurora, Colorado, United States, 80045

RECRUITING

United States, Florida

University of South Florida, Department of Psychiatry and Behavioral Neuroscience

Tampa, florida, United States, 33613

RECRUITING

United States, Georgia

Emory University

Atlanta, Georgia, United States, 30329

RECRUITING

United States, Hawaii

Hawaii Pacific Neuroscience

Honolulu, Hawaii, United States, 96817

RECRUITING

United States, Illinois

Rush University Medical Center

Chicago, Illinois, United States, 60612

RECRUITING

United States, Louisiana

LSU Health Shreveport

Shreveport, Louisiana, United States, 71103

RECRUITING

United States, Maryland

Sunstone Therapies, PC

Rockville, Maryland, United States, 20850

RECRUITING

United States, Maryland

Sheppard Pratt

Towson, Maryland, United States, 21204

RECRUITING

United States, Massachusetts

Dana Farber Cancer Institute

Boston, Massachusetts, United States, 02215

RECRUITING

United States, road cancer

Henry Ford Health

Novi, road cancer, United States, 48377

RECRUITING

United States, New Mexico

University of New Mexico, School of Medicine

Albuquerque, New Mexico, United States, 87131

RECRUITING

United States, New York

NYU Langone Center for Psychedelic Medicine

New York, New York, United States, 10016

RECRUITING

United States, North Carolina

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States, 27514

RECRUITING

United States, Ohio

Cleveland Clinic

Cleveland, Ohio, United States, 44113

RECRUITING

United States, Ohio

The Ohio State University, Department of Psychiatry

Columbus, Ohio, United States, 43210

RECRUITING

United States, Pennsylvania

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

RECRUITING

United States, Tennessee

Alliance for Multispecialty Research Clinical

Knoxville, Tennessee, United States, 37920

RECRUITING

United States, Texas

Dell Medical School, University of Texas at Austin

Austin, Texas, United States, 78712

RECRUITING

United States, Utah

Cedar Clinical Research Inc.

Draper, Utah, United States, 84020

RECRUITING

United States, Virginia

UVA Center for Psychiatric Clinical Research

Charlottesville, Virginia, United States, 22903

RECRUITING

United States, Washington

Seattle Neuropsychiatric Treatment Center

Seattle, Washington, United States, 98104