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

Launched by REUNION NEUROSCIENCE INC · May 23, 2025

Keywords

ClinConnect Summary

The RE104 Safety and Efficacy Study is a clinical trial designed to see if a single dose of a medication called RE104 can help reduce symptoms of Adjustment Disorder in people facing serious illnesses like cancer, ALS, MS, Parkinson's Disease, or Idiopathic Pulmonary Fibrosis. Adjustment Disorder can cause feelings of sadness or anxiety, especially when dealing with these challenging health conditions. The trial will compare how effective RE104 is against a placebo (a substance with no active medicine) to find out if it truly helps improve mental health.

To participate in the study, individuals aged 18 to 75 who have been experiencing symptoms of Adjustment Disorder for at least four weeks may be eligible. They should have a diagnosis confirmed by a healthcare professional and must not have certain serious mental health conditions, like bipolar disorder or schizophrenia. Participants should also be able to take care of themselves and be stable on their current medications. If someone joins the study, they can expect to receive either the RE104 treatment or a placebo and will be monitored closely throughout the trial. It's important for potential participants to be aware that they will need to follow specific guidelines and may need to delay some treatments until the study is completed.

Gender

ALL

Eligibility criteria

• 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, 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