A Phase 2 interventional study of Psilocybin therapy in Parkinson Disease, Depression and Anxiety, sponsored by Joshua Woolley, MD, PhD. Completed at 1 site in United States. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by Joshua Woolley, MD, PhD · Phase 2, Interventional, and Treatment
The purpose of this study is to determine the safety, tolerability, and feasibility of psilocybin therapy for depression and anxiety in people with Parkinson's disease.
This is an open-label single-arm pilot study of oral psilocybin therapy for depression and anxiety in people with Parkinson's Disease (PD). The primary goal is to examine safety, tolerability, and feasibility of the intervention in this patient population. We will enroll people ages 40 to 75 with clinically diagnosed early stage Parkinson's Disease (Hoehn and Yahr Stage 1-3 during an "off" period), who meet DSM-5 criteria for a depressive or anxious disorder and meet all other inclusion and exclusion criteria at screening. After baseline assessments, participants will complete preparation sessions designed to provide information about the psilocybin experience and to build rapport/trust with the study team. Next, participants will complete a first psilocybin administration session, receiving a low-moderate dose of 10 mg oral psilocybin in a supervised setting with safety monitoring by a physician. Participants who do not experience significant adverse events during or following the session will complete a second psilocybin administration session approximately two weeks later. During the second psilocybin administration session, participants will receive a moderate-high dose of 25 mg oral. The second session will involve the same procedures and level of monitoring as the first. Participants will subsequently complete multiple follow-up sessions designed to assess PD and psychiatric symptoms as well as to provide support as they process their psilocybin experiences. Follow-up will continue to 3 months after the second psilocybin administration session. Primary endpoints will assess safety, tolerability, and feasibility of study procedures. Exploratory efficacy endpoints will assess changes in depressive symptoms, anxious symptoms, and related measures of function.
4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.
This study's enrollment of 12 is below the median of 40 across 3,353 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Joshua Woolley, MD, PhD is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive one or two doses of psilocybin in a monitored setting approximately two weeks apart, with preparation sessions before and integration sessions after.
Drug: Psilocybin therapy
* Psilocybin administration session 1: 10mg delivered orally with psychological support and monitoring * Psilocybin administration session 2: 25mg delivered orally with psychological support and monitoring
Also known as: 4-phosphoryloxy-N,N-dimethyltryptamine
Movement Disorder Society-sponsored Revision of Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
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.
Time frame: 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)
Columbia Suicide Severity Rating Scale (C-SSRS)
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.
Time frame: 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)
Enhanced Scale for the Assessment of Positive Symptoms for Parkinson's Disease (eSAPS-PD)
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.
Time frame: 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)
Psychosis and Hallucinations in Parkinson's Disease Questionnaire (PsycH-Q)
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.
Time frame: 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)
Neuropsychiatric Inventory Caregiver Distress Questionnaire (NPI-Q)
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.
Time frame: 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)
11-Dimensional Altered States of Consciousness Rating Scale (11D-ASC)
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.
Time frame: Measured on each drug administration session day, following drug dose
Incidence of Adverse Events
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.
Time frame: 0-24 hours, 1-7 days, 8-14 days, 15-30 days, and 31-90 days after drug administration
Retention Rate
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.
Time frame: 90 days following last drug dose
Treatment Satisfaction Questionnaire (TSQ)
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.
Time frame: 30 days following last drug dose
Montgomery-Asberg Depression Rating Scale (MADRS)
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.
Time frame: 7 days following each drug dose; 30 and 90 days following last drug dose
Hamilton Anxiety Rating Scale (HAM-A)
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.
Time frame: 7 days following each drug dose; 30 and 90 days following last drug dose
Probabilistic Reversal Learning Task (PRL)
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.
Time frame: 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)
Cognitive Control and Flexibility Questionnaire (CCFQ)
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.
Time frame: 7 days following each drug dose; 30 days following last drug dose
Transformative Experience Questionnaire (TEQ)
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.
Time frame: 30 and 90 days following last drug dose
Quality of Life in Neurological Disorders (NeuroQoL) - Fatigue
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.
Time frame: 11, 25, and 90 days after the second drug dose (which takes place 2 weeks after first drug dose, i.e., 4-6 weeks after enrollment)
Quality of Life in Neurological Disorders (NeuroQoL) - Cognitive Function
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.
Time frame: 11, 25, and 90 days after the second drug dose (which takes place 2 weeks after first drug dose, i.e., 4-6 weeks after enrollment)
Quality of Life in Neurological Disorders (NeuroQoL) - Upper Extremities Function
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.
Time frame: 11, 25, and 90 days after the second drug dose (which takes place 2 weeks after first drug dose, i.e., 4-6 weeks after enrollment)
Quality of Life in Neurological Disorders (NeuroQoL) - Lower Extremities Function
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.
Time frame: 11, 25, and 90 days after the second drug dose (which takes place 2 weeks after first drug dose, i.e., 4-6 weeks after enrollment)
Quality of Life in Neurological Disorders (NeuroQoL) - Positive Affect & Wellbeing
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.
Time frame: 11, 25, and 90 days after the second drug dose (which takes place 2 weeks after first drug dose, i.e., 4-6 weeks after enrollment)
Quality of Life in Neurological Disorders (NeuroQoL) - Satisfaction With Social Roles & Activities
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.
Time frame: 11, 25, and 90 days after the second drug dose
Quality of Life in Neurological Disorders (NeuroQoL) - Concern With Death & Dying
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.
Time frame: 11, 25, and 90 days after the second drug dose (which takes place 2 weeks after first drug dose, i.e., 4-6 weeks after enrollment)
Quality of Life in Neurological Disorders (NeuroQoL) - Depression
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.
Time frame: 0, 11, 25, and 90 days after the second drug dose (which takes place 2 weeks after first drug dose, i.e., 4-6 weeks after enrollment)
Quality of Life in Neurological Disorders (NeuroQoL) - Anxiety
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.
Time frame: 0, 11, 25, and 90 days after the second drug dose (which takes place 2 weeks after first drug dose, i.e., 4-6 weeks after enrollment)
Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep-related Impairment
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.
Time frame: 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)
Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Disturbance
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.
Time frame: 7 days after first drug dose (which takes place 2-4 weeks after enrollment); 7 and 30 days after the second drug dose (which takes place 2 weeks after first drug dose, i.e., 4-6 weeks after enrollment)
Patient-Reported Outcomes Measurement Information System (PROMIS) - Apathy
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.
Time frame: 11, 18, 25, and 90 days after the second drug dose (which takes place 2 weeks after first drug dose, i.e., 4-6 weeks after enrollment)
Blood Markers for Inflammation & Mitochondrial Stress
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.
Time frame: 1 day after first drug dose (which takes place 2-4 weeks after enrollment); 1 and 30 days after the second drug dose (which takes place 2 weeks after first drug dose, i.e., 4-6 weeks after enrollment)
| Milestone | Psilocybin Therapy |
|---|---|
| Started | 12 |
| Completed | 12 |
| Not completed | 0 |
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.
| Total score | Psilocybin Therapy |
|---|---|
| 7 days following first drug dose | 56.455 ± 19.154 |
| 7 days following second drug dose | 51.917 ± 16.866 |
| 30 days following second drug dose | 49.917 ± 19.412 |
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.
| Total score | Psilocybin Therapy |
|---|---|
| 7 days following first drug dose | 0.167 ± 0.389 |
| 7 days following second drug dose | 0.167 ± 0.389 |
| 30 days following second drug dose | 0.417 ± 0.9 |
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.
| Total score | Psilocybin Therapy |
|---|---|
| 7 days following first drug dose | 0.5 ± 1 |
| 7 days following second drug dose | 1.167 ± 2.48 |
| 30 days following second drug dose | 1 ± 1.859 |
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.
| Total score | Psilocybin Therapy |
|---|---|
| On day of first dose, before discharge | 3.333 ± 7.303 |
| On day of second dose, before discharge | 1.833 ± 4.771 |
| 11 days following second drug dose | 1.333 ± 2.387 |
| 18 days following second drug dose | 1.5 ± 2.844 |
| 25 days following second drug dose | 2 ± 4.2 |
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.
| Subscale total score | Psilocybin Therapy |
|---|---|
| Severity: 7 days following first drug dose | 3.083 ± 2.937 |
| Severity: 7 days following second drug dose | 1.667 ± 3.055 |
| Severity: 30 days following second drug dose | 2.667 ± 2.348 |
| Severity: 90 days following second drug dose | 1.583 ± 1.379 |
| Distress: 7 days following first drug dose | 4.417 ± 5.16 |
| Distress: 7 days following second drug dose | 2.333 ± 4.397 |
| Distress: 30 days following second drug dose | 4.167 ± 3.927 |
| Distress: 90 days following second drug dose | 1.5 ± 1.624 |
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.
| Composite score | Psilocybin Therapy |
|---|---|
| First drug administration session | 47.935 ± 19.479 |
| Second drug administration session | 54.223 ± 17.653 |
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.
| Participants | Psilocybin Therapy |
|---|---|
| 0-24 hours after drug administration: 10mg psilocybin | 10 |
| 1-7 days after drug administration: 10mg psilocybin | 1 |
| 8-14 days after drug administration: 10mg psilocybin | 0 |
| 0-24 hours after drug administration: 25mg psilocybin | 10 |
| 1-7 days after drug administration: 25mg psilocybin | 2 |
| 8-14 days after drug administration: 25mg psilocybin | 2 |
| 15-30 days after drug administration: 25mg psilocybin | 2 |
| 31-90 days after drug administration: 25mg psilocybin | 1 |
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.
| Participants | Psilocybin Therapy |
|---|---|
| Retention Rate | 12 |
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.
| Item-level score | Psilocybin Therapy |
|---|---|
| Item 1: Treatment Acceptability | 6.5 ± 0.522 |
| Item 2: Satisfaction with Treatment | 6.333 ± 0.888 |
| Item 3: Treatment was challenging. | 5.75 ± 1.545 |
| Item 4: Usefulness/Helpfulness of Treatment | 6.417 ± 0.793 |
| Item 5: Would recommend this Treatment. | 6.333 ± 0.778 |
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.
| Total score | Psilocybin Therapy |
|---|---|
| 7 days following first drug dose | 16.167 ± 9.684 |
| 7 days following last drug dose | 13.083 ± 7.692 |
| 30 days following last drug dose | 13.583 ± 9.848 |
| 90 days following last drug dose | 11.667 ± 9.432 |
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.
| Total score | Psilocybin Therapy |
|---|---|
| 7 days following first drug dose | 15.5 ± 6.474 |
| 7 days following last drug dose | 12.083 ± 6.022 |
| 30 days following last drug dose | 13.417 ± 7.501 |
| 90 days following last drug dose | 12.75 ± 6.384 |
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.
| Number of successful reversals | Psilocybin Therapy |
|---|---|
| 7 days following first drug dose | 4.833 ± 1.749 |
| 7 days following second drug dose | 5.455 ± 2.252 |
| 30 days following second drug dose | 5.9 ± 2.601 |
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.
| Total score | Psilocybin Therapy |
|---|---|
| 7 days following first drug dose | 72 ± 13.987 |
| 7 days following last drug dose | 71.833 ± 9.084 |
| 30 days following last drug dose | 73.333 ± 13.276 |
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.
| Total score | Psilocybin Therapy |
|---|---|
| 30 days after last drug dose | 12.167 ± 2.037 |
| 90 days after last drug dose | 12 ± 2.663 |
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.
| Total score | Psilocybin Therapy |
|---|---|
| 11 days after second drug dose | 24.000 ± 6.164 |
| 25 days after second drug dose | 21.500 ± 6.053 |
| 90 days after second drug dose | 21.667 ± 7.981 |
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.
| Total score | Psilocybin Therapy |
|---|---|
| 11 days after second drug dose | 20.250 ± 6.552 |
| 25 days after second drug dose | 19.083 ± 6.694 |
| 90 days after second drug dose | 18.583 ± 6.459 |
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.
| Total score | Psilocybin Therapy |
|---|---|
| 11 days after second drug dose | 11.167 ± 4.687 |
| 25 days after second drug dose | 12.000 ± 4.533 |
| 90 days after second drug dose | 11.750 ± 4.634 |
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.
| Total score | Psilocybin Therapy |
|---|---|
| 11 days after second drug dose | 10.417 ± 2.575 |
| 25 days after second drug dose | 10.833 ± 3.215 |
| 90 days after second drug dose | 11.333 ± 3.525 |
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.
| Total score | Psilocybin Therapy |
|---|---|
| 11 days after the second drug dose | 29.750 ± 5.379 |
| 25 days after the second drug dose | 30.250 ± 6.690 |
| 90 days after the second drug dose | 30.083 ± 6.882 |
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.
| Total score | Psilocybin Therapy |
|---|---|
| 11 days after the second drug dose | 21.583 ± 5.915 |
| 25 days after the second drug dose | 22.083 ± 6.999 |
| 90 days after the second drug dose | 20.917 ± 8.028 |
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.
| Total score | Psilocybin Therapy |
|---|---|
| 11 days after the second drug dose | 13.833 ± 4.428 |
| 25 days after the second drug dose | 12.500 ± 4.189 |
| 90 days after the second drug dose | 13.333 ± 3.499 |
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.
| Total score | Psilocybin Therapy |
|---|---|
| 0 days after second drug dose | 15.750 ± 6.552 |
| 11 days after second drug dose | 15.167 ± 3.271 |
| 25 days after second drug dose | 15.833 ± 4.345 |
| 90 days after second drug dose | 15.417 ± 5.712 |
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.
| Total score | Psilocybin Therapy |
|---|---|
| 0 days after second drug dose | 19.917 ± 4.833 |
| 11 days after second drug dose | 17.917 ± 4.188 |
| 25 days after second drug dose | 18.667 ± 4.228 |
| 90 days after second drug dose | 17.250 ± 6.137 |
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.
| Total score | Psilocybin Therapy |
|---|---|
| 7 days after first drug dose | 44.750 ± 12.920 |
| 7 days after second drug dose | 42.000 ± 11.771 |
| 30 days after second drug dose | 40.583 ± 13.721 |
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.
| Total score | Psilocybin Therapy |
|---|---|
| 7 days after first drug dose | 71.417 ± 16.020 |
| 7 days after second drug dose | 66.667 ± 16.784 |
| 30 days after second drug dose | 66.917 ± 24.024 |
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.
| Total score | Psilocybin Therapy |
|---|---|
| 11 days after the second drug dose | 12.833 ± 3.927 |
| 18 days after the second drug dose | 11.182 ± 3.790 |
| 25 days after the second drug dose | 11.833 ± 4.821 |
| 90 days after the second drug dose | 12.667 ± 4.579 |
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.
| Participants | Psilocybin Therapy |
|---|---|
| 1 day after first drug dose | 9 |
| 1 day after second drug dose | 9 |
| 30 days after second drug dose | 9 |
Collected over Adverse Events data were collected starting from enrollment to 90 days after the last dosing session.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Psilocybin Therapy | 0/12 (0%) | 0/12 (0%) | 11/12 (91.7%) |
| Event | Psilocybin Therapy |
|---|---|
| AnxietyPsychiatric disorders | 11/12 |
| NauseaGastrointestinal disorders | 11/12 |
| Blood pressure increasedCardiac disorders | 9/12 |
| HeadacheMusculoskeletal and connective tissue disorders | 8/12 |
| TachycardiaCardiac disorders | 3/12 |
| TremorNervous system disorders | 3/12 |
| Sensory disturbancePsychiatric disorders | 3/12 |
| Motor dysfunctionNervous system disorders | 2/12 |
| InsomniaGeneral disorders | 2/12 |
| Feeling jitteryPsychiatric disorders | 1/12 |
| Age, Continuous(Years) | Psilocybin Therapy |
|---|---|
| Mean | 63.2 ± 8.2 |
| Sex: Female, Male(Participants) | Psilocybin Therapy |
|---|---|
| Female | 5 |
| Male | 7 |
| Race (NIH/OMB)(Participants) | Psilocybin Therapy |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 12 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Movement Disorder Society-sponsored revision of Unified Parkinson's Disease Rating Scale (MDS-UPDRS)(Total score) | Psilocybin Therapy |
|---|---|
| Mean | 76.333 ± 21.652 |
| Columbia Suicide Severity Rating Scale (C-SSRS)(Total score) | Psilocybin Therapy |
|---|---|
| Mean | 1.083 ± 1.24 |
| Enhanced Scale for the Assessment of Positive Symptoms for Parkinson's Disease (eSAPS-PD)(Total score) | Psilocybin Therapy |
|---|---|
| Mean | 2.333 ± 3.525 |
| Psychosis and Hallucinations in Parkinson's Disease Questionnaire (PsycH-Q)(Total score) | Psilocybin Therapy |
|---|---|
| Mean | 3.25 ± 5.172 |
| Neuropsychiatric Inventory Caregiver Distress Questionnaire (NPI-Q)(Total score) | Psilocybin Therapy |
|---|---|
| Severity | 6.75 ± 3.911 |
| Distress | 7.667 ± 5.228 |
17 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
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Studies of the drug tested here: Psilocybin