RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2025-07-30
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07002034

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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, management, recurrence, prognosis): Cancer, ALS, MS, PD or IPF
  2. * Is sufficiently ambulatory and capable of self care as necessary to complete study procedures
  3. * Has normal cognitive function
  4. * Is on stable use of antidepressants or psychotherapy, or is willing to delay use until the end of study
  5. * If female is not pregnant or planning to become pregnant. If male is not planning to make a partner pregnant
  6. * Is willing and able to comply with the conditions and requirements of the study
  1. * Has a significant risk of suicide
  2. * 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
  3. * Has active or a history of central nervous system malignancy
  4. * Has other medically significant conditions rendering unsuitability for the study
  5. * Has used or will need to use prohibited medications or therapies
  6. * Has a known sensitivity or intolerance to study intervention or potential rescue medications

Contacts and Locations

Study Contact

Mark Pollack, Chief Medical Officer
CONTACT
1-888-880-REUN
info@reunionneuro.com

Principal Investigator

Mark Pollack, Chief Medical Officer
STUDY_DIRECTOR
Reunion Neuroscience Inc

Study Locations (Sites)

UAB, Psychiatry and Behavioral Neurology
Birmingham, Alabama, 35209
United States
University of South Florida, Department of Psychiatry and Behavioral Neuroscience
Tampa, Florida, 33613
United States
Sunstone Therapies, PC
Rockville, Maryland, 20850
United States
Henry Ford Health
Novi, Michigan, 48377
United States
University of New Mexico, School of Medicine
Albuquerque, New Mexico, 87131
United States

Collaborators and Investigators

Sponsor: Reunion Neuroscience Inc

  • Mark Pollack, Chief Medical Officer, STUDY_DIRECTOR, Reunion Neuroscience Inc

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-30
Study Completion Date2026-12

Study Record Updates

Study Start Date2025-07-30
Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

  • Cancer
  • Amyotrophic Lateral Sclerosis (ALS)
  • Multiple Sclerosis (MS)
  • Parkinson's Disease (PD)
  • Idiopathic Pulmonary Fibrosis (IPF)
  • Depression
  • Anxiety
  • Psychiatric Distress

Additional Relevant MeSH Terms

  • Adjustment Disorder