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Reunion Neuroscience — REKINDLE Study

Reunion Neuroscience — REKINDLE Study

Summary:

The REKINDLE Study is testing an investigational single-dose, short-acting psychedelic medication to see if it can help promote better mental health in people with symptoms of depression and anxiety linked to adjustment disorder due to a serious medical illness.

What does participation involve?

Interested potential study participants will be screened at a Study Center where they will be assessed to ensure they can participate safely. During the Screening process, Study Participants will also meet and get to know their Session Monitors, professionals trained to guide and stay with them during their psychedelic experience.

Participants will receive a single dose of the study medication or a low-dose comparator at the Study Center and will be monitored in a comfortable environment. Study Participants will have a 50/50 chance (like the flip of a coin) of being assigned to either group. Study Participants will then be followed for six weeks to evaluate their symptoms and check on their safety.

Including the Screening Period, Dosing Visit, and the Follow-up Period, participation in this study will last up to ten weeks.

To be eligible to participate, you must be:

  • Between 18 and 80 years old
  • Diagnosed with cancer (stages 0-4) or other serious conditions such as Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), Parkinson’s disease (PD), or idiopathic pulmonary fibrosis (IPF)
  • Experiencing symptoms of depression and/or anxiety and feeling overwhelmed for at least four weeks
  • Sufficiently ambulatory and capable of self-care as needed to complete study procedures
  • Have normal cognitive function
  • On stable use of antidepressants or psychotherapy, or 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
  • 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

Locations:

This study has 24 sites open to screening, with more opening soon. For detail on site locations and contacts, please visit:

https://clinicaltrials.gov/study/NCT07002034#contacts-and-locations

How to sign up for this study:

If you’d like to participate, click the link below to learn more details and confirm your eligibility.

https://www.rekindlestudies.com/