Clinical Trials for Supranuclear Palsy
There is currently 1 ongoing clinical trial investigating treatment options for patients with supranuclear palsy and related conditions. This trial focuses on using psilocybin therapy to address psychological distress and depression in patients with progressive neurological diseases, conducted across multiple European countries.
Clinical trial locations
- Czechia
- Denmark
- Netherlands
- Portugal
Study of psilocybin therapy for psychological distress in patients with COPD, ALS, multiple sclerosis, or atypical Parkinson’s disorders
This clinical trial is investigating whether psilocybin therapy can help reduce depression and psychological distress in patients living with progressive medical conditions. The study includes patients with chronic obstructive pulmonary disease, amyotrophic lateral sclerosis, multiple sclerosis, and atypical Parkinson disorders, including progressive supranuclear palsy.
Main inclusion criteria: To participate in this trial, you must have a confirmed diagnosis of one of the qualifying conditions: COPD, ALS, MS, or atypical Parkinson disorder (including progressive supranuclear palsy). You must also be diagnosed with major depressive disorder and score higher than 19 on the MADRS depression rating scale. Participants must be at least 18 years old, have a life expectancy of at least 6 months, and have an identified caregiver or support person. You must be able to read and understand consent forms in your local language, attend all study visits, and be able to swallow capsules.
For patients with atypical Parkinson disorders specifically, you must have advanced to late-stage symptoms and show evidence of both motor and non-motor fluctuations.
Main exclusion criteria: You cannot participate if you have a personal or family history of schizophrenia, psychosis, or bipolar disorder. Current suicidal thoughts with specific plans or suicide attempts in the past year will exclude you from participation. Active substance abuse or dependence in the past 6 months (except nicotine), severe heart conditions, uncontrolled high blood pressure, or severe liver or kidney problems are also reasons for exclusion. Pregnant or breastfeeding women, or those planning to become pregnant, cannot participate. You will also be excluded if you are currently using medications that could interact with psilocybin, including certain antidepressants, or if you have severe cognitive impairment that would affect participation in therapy sessions.
Study focus: The main goal of this research is to evaluate whether medium to high doses of psilocybin therapy are safe and effective in reducing depression symptoms compared to low doses in patients with serious progressive conditions. The study will monitor changes in psychological well-being, including the ability to cope with end-of-life concerns, overall quality of life, and general mental health. Researchers will also examine how the treatment affects the stress levels and daily responsibilities of caregivers.
Treatment approach: Participants will receive two doses of psilocybin capsules during the study. The doses will be either 1 mg (low dose) or 15-25 mg (medium to high dose), given by mouth under medical supervision. Depression symptoms will be evaluated before treatment begins and six weeks after the second dose. The treatment period lasts approximately two months, with follow-up evaluations to track participants’ progress.
Investigational drug: Psilocybin is a naturally occurring psychedelic compound being studied as a potential therapy for psychological distress and depression. In this trial, it is being investigated as a treatment for patients with serious medical conditions who are experiencing depression. The therapy involves administering psilocybin in different doses along with psychological support to help patients process their experiences and potentially reduce their depressive symptoms. Psilocybin works by binding to serotonin receptors in the brain, which can lead to altered mood and perception in ways that may help reduce psychological distress.
Summary
Currently, there is one clinical trial available for patients with progressive supranuclear palsy and related atypical Parkinson disorders who are experiencing depression. This trial represents a novel approach to treating psychological distress in patients with serious progressive conditions, focusing on psilocybin therapy as a potential treatment option. The study is being conducted across four European countries: Czechia, Denmark, the Netherlands, and Portugal, providing access to patients in multiple locations. The trial takes a comprehensive approach by including several progressive conditions in one study, recognizing that patients with these diseases often experience similar psychological challenges. This research may provide important insights into new treatment options for depression in patients living with progressive neurological conditions.