RECRUITING

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

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.

Conditions

Adjustment Disorder
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Related Conditions:

Adjustment Disorder

Study Overview

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Study Details

Study overview

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.

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

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

Condition
Adjustment Disorder
Intervention / Treatment

-

Contacts and Locations

Birmingham

UAB, Psychiatry and Behavioral Neurology, Birmingham, Alabama, United States, 35209

Tampa

University of South Florida, Department of Psychiatry and Behavioral Neuroscience, Tampa, Florida, United States, 33613

Rockville

Sunstone Therapies, PC, Rockville, Maryland, United States, 20850

Novi

Henry Ford Health, Novi, Michigan, United States, 48377

Albuquerque

University of New Mexico, School of Medicine, Albuquerque, New Mexico, United States, 87131

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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, 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
  • * 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

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Reunion Neuroscience Inc,

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

Study Record Dates

2026-12