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

Study Status: Recruiting

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.

Sex: ALL
Minimum Age: 18 Years
Maximum Age: 80 Years

Researchers look for people who fit a certain description, called eligibility criteria. Below are the inclusion and exclusion criteria for study participants:

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

Exlusion 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