RE104 Safety and Efficacy Study in Adjustment Disorder in Cancer and Other Medical Illnesses
ConditionAdjustment Disorder
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorReunion Neuroscience Inc
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- RE104 for Injection
Treatment groups
100 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov