IRB Study Number 25-722
Status Recruiting
Phase Phase 2
Location Lutheran Hospital
Institute Neurological Institute
Description
The REKINDLE study is exploring whether an investigational psychedelic treatment may support improved mental health for people experiencing depression or anxiety related to adjustment disorder following a major medical illness.
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.
Adjustment disorder can show up in different ways for different people, but some of the more common signs include:
- Persistent sadness, crying or emotional numbness
- Loss of interest in daily activities
- Trouble sleeping or concentrating
- Overwhelming worry or fear
- Withdrawing from friends, family, or work
- Feeling hopeless about the future
Key inclusion and exclusion items listed below. Full eligibility criteria will be assessed during the screening period.
Inclusion Criteria
- Age 18-80 at time of screening
- 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
