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RECRUITINGPhase 2INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

RE104 for Injection

Single, subcutaneous dose of RE104 for Injection

Locations (20)

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
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