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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Sep 15, 2026 · Source: ClinicalTrials.gov
The study is currently accepting participants.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Reunion Neuroscience Inc
- Interventions being studied
- Drug: RE104 for Injection
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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
- 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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- UAB, Psychiatry and Behavioral NeurologyBirmingham, Alabama
- University of ArizonaTucson, Arizona
- Kadima Neuropsychiatry InstituteSan Diego, California
- Providence Medical FoundationSanta Rosa, California
- University of ColoradoAurora, Colorado
- University of South Florida, Department of Psychiatry and Behavioral NeuroscienceTampa, Florida
- Emory UniversityAtlanta, Georgia
- Hawaii Pacific NeuroscienceHonolulu, Hawaii
- Rush University Medical CenterChicago, Illinois
- University of Chicago Medical CenterChicago, Illinois
- The University of Kansas Medical CenterKansas City, Kansas
- LSU Health ShreveportShreveport, Louisiana
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 15, 2026. Always confirm current availability with the study team.