Trial Outcomes & Findings for Psilocybin Therapy for Depression and Anxiety in Parkinson's Disease (NCT NCT04932434)

The measure was added to the study protocol after the first participant was enrolled in the study.

This clinician-administered assessment measures the severity of Parkinson's disease symptoms.The MDS-UPDRS has four subscales: * I: Non-motor Experiences of Daily Living -- 13 items * II: Motor Experiences of Daily Living -- 13 items * III: Motor Examination -- 33 items * IV: Motor Complications -- 6 items All 65 items across subscales are rated on a 5-point scale (0-4). Total scores were calculated by summing the scores across all 65 items. Higher scores indicate more severe Parkinson's disease symptoms.

The C-SSRS measures suicidal ideation (SI) in 6 categories, each scored on a binary scale of Yes or No (coded 1 or 0, respectively): 1) Wish to be Dead; 2) Non-specific Active Suicidal Thoughts; 3) Active SI with Any Methods (Not Plan) without Intent to Act; 4) Active SI with Some Intent to Act, without Specific Plan; 5) Active SI with Specific Plan and Intent; 6) Preparatory Acts or Behavior. Total scores are calculated as the sum of the 6 items ratings; the possible range of total scores is from 0 to 6. Higher total scores indicate more severe SI.

The eSAPS-PD measures the severity of positive psychotic symptoms in individuals with Parkinson's disease. Total scores are calculated as the sum of 11 items, each rated on a scale from 0 - 5: Minor Hallucinations, Gustatory Hallucinations, Olfactory Hallucinations, Auditory Hallucinations, Somatic or Tactile Hallucinations, Visual Hallucinations, Persecutory Delusions, Delusions of Jealousy, Delusions of Reference, Capgras Syndrome, and Other Delusions. The range of possible total scores is 0 to 55. Higher total scores indicate more severe psychotic symptoms.

This self-report questionnaire measures psychotic symptoms in individuals with Parkinson's disease. The questionnaire assesses the frequency and severity of 20 symptom. The frequency of each item is rated from 0 to 4, and the severity of each item is rated from 1 to 4. Scores for each item are determined by multiplying the frequency rating and severity rating. Total scores are then calculated by summing the scores on all 20 items. Possible total scores range from 0 to 320. Higher total scores indicate more severe and more frequent psychotic symptoms.

This self-report measure is administered to caregivers of participants with Parkinson's disease. Respondents are asked to rate the severity of the symptoms of the individual in their care, as well as the degree of distress this causes them personally (as the caregiver). Twelve symptoms are assessed for both severity and distress, rated on scales from 1 to 3 and 0 to 5, respectively. Total scores on the severity and distress subscales are calculated by summing the respective ratings across the twelve items. Possible total scores range from 12 to 36 on the severity subscale, and from 0 to 60 on the distress subscale.

This 94-item, self-report questionnaire measures alterations in perception and cognition following administration of psilocybin. Each item is rated on a scale from 0 to 100. 11 subscales are calculated to measure alterations across different dimensions of perception and cognition, with a composite score consisting of the average score across the 11 subscales. Average composite scores have been reported here.

The incidence of Adverse Events are reported here by the amount of, and timing relative to, the study drug dose as a measure of the safety and tolerability of psilocybin therapy for depression and anxiety in individuals with Parkinson's disease.

The number of participants completing all stages of the study will be presented as a percentage of the number of total number of participants enrolled in the study.

The Treatment Satisfaction Questionnaire (TSQ) was developed in house to measure participants' overall satisfaction with the study treatment. The measure consists of 5 items rated on a scale from 1 to 7 and three free-response questions (free response items not reported here). Reported are average scores on each of the five items; higher scores represent stronger agreement with the sentiment expressed.

A clinician-administered assessment used to rate the severity of depressive symptoms. The scale consists of 10 items rated on a scale from 0 to 6. Total scores range from 0 to 60, with higher scores indicating more severe depressive symptoms.

This clinician-administered assessment measures severity of anxiety symptoms. Each item is scored on a scale of 0 to 4 with a total score range of 0-56. Higher total scores correspond to more severe anxiety symptoms.

This task is a behavioral paradigm used to measure cognitive flexibility and reward-guided learning. Participants repeatedly choose between stimuli where the "correct" choice only yields a reward 80% of the time, while the "incorrect" choice yields a reward 20% of the time. Once a participant figures out the optimal stimulus, the reward contingencies unexpectedly reverse. Reported here is the average number of successful reversals in a set of 50 trials. Higher numbers of reversals reflect greater cognitive flexibility.

This self-report questionnaire measures an individual's perceived ability to exert control over intrusive, unwanted (negative) thoughts and emotions, and their ability to flexibly cope with a stressful situation. This measure consists of 18 items rated on a scale from 1 to 7, with total scores ranging from 0 to 126. Higher scores indicate better outcomes.

This self-report questionnaire was developed in house to assess the personal significance or transformative experience of psilocybin therapy participants experienced during this trial. The questionnaire consists of two items rated on a scale from 1 to 7 each, with total scores ranging from 2 to 14. Higher total scores indicate more transformative experiences.

This survey is part of a collection of measures that assess quality of life in adults with neurological disorders. This subscale measures participant fatigue using 8 self-report items. All items are rated from 1 to 5. Total scores are calculated as the sum of all 8 items' ratings, ranging from 8 to 40. Higher total scores correspond to worse quality of life.

This survey is part of a collection of measures that assess quality of life in adults with neurological disorders. This subscale measures participant's cognitive function using 8 self-report items. All items are rated from 1 to 5. Total scores are calculated as the sum of all 8 items' ratings, ranging from 8 to 40. Higher total scores correspond to worse quality of life.

This survey is part of a collection of measures that assess quality of life in adults with neurological disorders. This subscale measures participant's upper extremities function using 8 self-report items. All items are rated from 1 to 5. Total scores are calculated as the sum of all 8 items' ratings, ranging from 8 to 40. Higher total scores correspond to worse quality of life.

This survey is part of a collection of measures that assess quality of life in adults with neurological disorders. This subscale measures participant's lower extremities function using 8 self-report items. All items are rated from 1 to 5. Total scores are calculated as the sum of all 8 items' ratings, ranging from 8 to 40. Higher total scores correspond to worse quality of life.

This survey is part of a collection of measures that assess quality of life in adults with neurological disorders. This subscale measures participant's positive affect using 9 self-report items. All items are rated from 1 to 5. Total scores are calculated as the sum of all 9 items' ratings, ranging from 9 to 45. Higher total scores correspond to worse quality of life.

This survey is part of a collection of measures that assess quality of life in adults with neurological disorders. This subscale measures participant's satisfactions wiht their social roles and activities using 8 self-report items. All items are rated from 1 to 5. Total scores are calculated as the sum of all 8 items' ratings, ranging from 8 to 40. Higher total scores correspond to worse quality of life.

This survey is part of a collection of measures that assess quality of life in adults with neurological disorders. This subscale measures participant's concern with death and dying using 6 self-report items. All items are rated from 1 to 5. Total scores are calculated as the sum of all 8 items' ratings, ranging from 6 to 30. Higher total scores correspond to worse quality of life.

This survey is part of a collection of measures that assess quality of life in adults with neurological disorders. This subscale measures participant's depressive symptoms using 8 self-report items. All items are rated from 1 to 5. Total scores are calculated as the sum of all 8 items' ratings, ranging from 8 to 40. Higher total scores correspond to worse quality of life.

This survey is part of a collection of measures that assess quality of life in adults with neurological disorders. This subscale measures participant's anxiety symptoms using 8 self-report items. All items are rated from 1 to 5. Total scores are calculated as the sum of all 8 items' ratings, ranging from 8 to 40. Higher total scores correspond to worse quality of life.

PROMIS is a set of publicly available, NIH-funded measures used to evaluate and monitor physical, mental, and social health in adults and children. This self-report survey is one of the assessments in the PROMIS battery. It consists of 16 items that measure sleep-related impairment in cognition and function, each rated on a scale from 1 to 5. Total scores are calculated as the simple sum of ratings across all 16 items, and range from 16 to 80. Higher total scores correspond to worse outcomes.

PROMIS is a set of publicly available, NIH-funded measures used to evaluate and monitor physical, mental, and social health in adults and children. This self-report survey is one of the assessments in the PROMIS battery. It consists of 27 items that measure sleep disturbances, each rated on a scale from 1 to 5. Total scores are calculated as the simple sum of ratings across all 27 items, and range from 27 to 135. Higher total scores correspond to worse outcomes.

PROMIS is a set of publicly available, NIH-funded measures used to evaluate and monitor physical, mental, and social health in adults and children. This self-report survey is one of the assessments in the PROMIS battery. It consists of 7 items that measure apathy, each rated on a scale from 1 to 4. Total scores are calculated as the simple sum of ratings across all 7 items, and range from 7 to 28. Higher total scores correspond to worse outcomes.

Blood samples were collected from participants for archiving and eventual analysis (to be supported by another funding source) of serum-based biomarkers for inflammation and mitochondrial stress, including but not limited to interleukins, tumor necrosis factors, and C-reactive proteins. The number of participants from whom blood samples were collected at each follow-up time point is reported below.