Psilocybin Therapy for Depression and Anxiety in Parkinson's Disease: a Pilot Study

Parkinson's Disease (PD) symptom severity

时间窗: Baseline to 30 days following last drug dose

Measured by Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

Participant-reported subjective experience

时间窗: Measured on each drug administration session day, following drug dose

Measured by 5-Dimensional Altered States of Consciousness Rating Scale (5D-ASC)

Suicide Risk

时间窗: Baseline to 30 days following last drug dose

Measured by Columbia Suicide Severity Rating Scale (C-SSRS)

Psychotic symptoms

时间窗: Baseline to 30 days following last drug dose

Measured by Psychosis and Hallucinations Questionnaire in Parkinson's Disease (PsycH-Q)

Cognitive Safety

时间窗: Baseline to 30 days following last drug dose

Measured by Cambridge Neuropsychological Test Automated Battery (CANTAB)

Caregiver/support person-reported distress

时间窗: Baseline to 90 days following last drug dose

Measured by Neuropsychiatric Inventory Caregiver Distress Questionnaire (NPI-Q)

Safety and tolerability of psilocybin therapy for depression and anxiety in people with PD

时间窗: Baseline to 3 months following last drug dose

Incidence, severity, and frequency of Adverse Events (AEs) including Treatment-Emergent AEs (TEAEs) and Serious AEs (SAEs)

Recruitment rate

时间窗: Baseline to 3 months following last drug dose

Measured by the number of participants entering the trial multiplied by the number of months of active recruitment time

Retention rate

时间窗: Baseline to 3 months following last drug dose

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

Treatment Satisfaction of psilocybin therapy for depression and anxiety in people with PD

时间窗: Baseline to 3 months following last drug dose

Measured by the treatment satisfaction questionnaire * 5-item scale, plus three free response questions * items are ranked from 1-to-7, with higher scores representing better treatment satisfaction

Movement Disorder Society-sponsored Revision of Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

时间窗: 7 days after first drug dose (which takes place 2-4 weeks after enrollment); 7 and 30 days after second drug dose (which takes place 2 weeks after first drug dose, i.e., 4-6 weeks after enrollment)

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.

Columbia Suicide Severity Rating Scale (C-SSRS)

时间窗: 7 days after first drug dose (which takes place 2-4 weeks after enrollment); 7 and 30 days after second drug dose (which takes place 2 weeks after first drug dose, i.e., 4-6 weeks after enrollment)

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.

Enhanced Scale for the Assessment of Positive Symptoms for Parkinson's Disease (eSAPS-PD)

时间窗: 7 days after first drug dose (which takes place 2-4 weeks after enrollment); 7 and 30 days after second drug dose (which takes place 2 weeks after first drug dose, i.e., 4-6 weeks after enrollment)

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.

Psychosis and Hallucinations in Parkinson's Disease Questionnaire (PsycH-Q)

时间窗: On day of first drug dose (which takes place 2-4 weeks after enrollment); On day of, and 11, 18, and 25 days following second drug dose (which takes place 2 weeks after first drug dose, i.e., 4-6 weeks after enrollment)

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.

Neuropsychiatric Inventory Caregiver Distress Questionnaire (NPI-Q)

时间窗: 7 days after first drug dose (which takes place 2-4 weeks after enrollment); 7, 30, and 90 days after second drug dose (which takes place 2 weeks after first drug dose, i.e., 4-6 weeks after enrollment)

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.

11-Dimensional Altered States of Consciousness Rating Scale (11D-ASC)

时间窗: Measured on each drug administration session day, following drug dose

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.

Incidence of Adverse Events

时间窗: 0-24 hours, 1-7 days, 8-14 days, 15-30 days, and 31-90 days after drug administration

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.

Retention Rate

时间窗: 90 days following last drug dose

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.

Treatment Satisfaction Questionnaire (TSQ)

时间窗: 30 days following last drug dose

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.