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

Recruiting now · Phase 2

Conditions studied: Adjustment Disorder

In brief

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.

Key facts

Study ID

NCT07002034

Run by

Reunion Neuroscience Inc

People needed

100

Starts

2025-07-30

Expected to finish

2026-12-01

Last updated by the study team

2026-08-06

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UAB, Psychiatry and Behavioral Neurology — Birmingham, Alabama, United States (enrolling)
• University of Arizona — Tucson, Arizona, United States (enrolling)
• Kadima Neuropsychiatry Institute — San Diego, California, United States (enrolling)
• Providence Medical Foundation — Santa Rosa, California, United States (enrolling)
• University of Colorado — Aurora, Colorado, United States (enrolling)
• University of South Florida, Department of Psychiatry and Behavioral Neuroscience — Tampa, Florida, United States (enrolling)
• Emory University — Atlanta, Georgia, United States (enrolling)
• Hawaii Pacific Neuroscience — Honolulu, Hawaii, United States (enrolling)
• Rush University Medical Center — Chicago, Illinois, United States (enrolling)
• The University of Kansas Medical Center — Kansas City, Kansas, United States (enrolling)
• LSU Health Shreveport — Shreveport, Louisiana, United States (enrolling)
• Sunstone Therapies, PC — Rockville, Maryland, United States (enrolling)
• Sheppard Pratt — Towson, Maryland, United States (enrolling)
• Dana Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
• University of Michigan — Ann Arbor, Michigan, United States (enrolling)
• Henry Ford Health — Novi, Michigan, United States (enrolling)
• University of Nebraska Medical Center — Omaha, Nebraska, United States (enrolling)
• University of New Mexico, School of Medicine — Albuquerque, New Mexico, United States (enrolling)
• Roswell Park Center Institute — Buffalo, New York, United States (enrolling)
• NYU Langone Health — New York, New York, United States (enrolling)
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (enrolling)
• Cleveland Clinic — Cleveland, Ohio, United States (enrolling)
• The Ohio State University, Department of Psychiatry — Columbus, Ohio, United States (enrolling)
• University of Pennsylvania — Philadelphia, Pennsylvania, United States (enrolling)
• Alliance for Multispecialty Research Clinical — Knoxville, Tennessee, United States (enrolling)

Full record on ClinicalTrials.gov

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