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

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.

ClinicalTrials.gov IDNCT07002034

PhasePHASE2

Enrollment100

SponsorReunion Neuroscience Inc

Age18 Years – 80 Years

SexALL

I'm interested View official listing

Conditions studied

Adjustment Disorder

About this study

Interventions

Drug: RE104 for Injection — Single, subcutaneous dose of RE104 for Injection

Primary outcomes

RE104 30 mg versus RE104 1.5 mg change from baseline in MADRS total score (Day 7)

Eligibility information

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

Study locations

UAB, Psychiatry and Behavioral Neurology, Birmingham, Alabama 35209 United States
University of Arizona, Tucson, Arizona 85724 United States
Kadima Neuropsychiatry Institute, San Diego, California 92037 United States
Providence Medical Foundation, Santa Rosa, California 95403 United States
University of Colorado, Aurora, Colorado 80045 United States
University of South Florida, Department of Psychiatry and Behavioral Neuroscience, Tampa, Florida 33613 United States
Emory University, Atlanta, Georgia 30329 United States
Hawaii Pacific Neuroscience, Honolulu, Hawaii 96817 United States
Rush University Medical Center, Chicago, Illinois 60612 United States
University of Chicago Medical Center, Chicago, Illinois 60637 United States

Showing 10 of 32 reported sites. See the official listing for all locations.

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-08.