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Phase 2Recruiting

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

Sponsored by Reunion Neuroscience Inc

About this study

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.

Where this study is enrolling (32)

Show all 32 locations
Who can participate

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

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.