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Psilocybin Therapy for Depression and Anxiety in Parkinson's Disease (PDP)

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ClinicalTrials.gov Identifier: NCT04932434
Recruitment Status : Recruiting
First Posted : June 21, 2021
Last Update Posted : September 5, 2021
Sponsor:
Information provided by (Responsible Party):
Joshua Woolley, MD/PhD, University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE May 5, 2021
First Posted Date  ICMJE June 21, 2021
Last Update Posted Date September 5, 2021
Actual Study Start Date  ICMJE August 15, 2021
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 11, 2021)
  • Safety and tolerability of psilocybin therapy for depression and anxiety in people with PD [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2021)
  • Effects of psilocybin therapy on depression in people with PD (exploratory) [ Time Frame: Baseline to 3 months following last drug dose ]
    • Measured by the Montgomery-Asberg Depression Rating Scale (MADRS)
    • Each item is scored on a on a scale of 0 to 6, with a total score of 0 to 60
    • Higher scores correspond to worse outcomes
  • Effects of psilocybin therapy on anxiety in people with PD (exploratory) [ Time Frame: Baseline to 3 months following last drug dose ]
    • Changes in anxiety assessed by the Hamilton Anxiety (HAM-A) Rating Scale
    • Each item is scored on a scale of 0 to 4 with a total score range of 0-56
    • Higher total scores correspond to worse outcomes
  • Effects of psilocybin therapy on self-reported apathy (exploratory) [ Time Frame: Baseline to 3 months following last drug dose ]
    Measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Apathy Scale
    • Each item is scored on a scale of 1 to 4 with a total score range of 7-28
    • Lower total scores correspond to worse outcomes
  • Effects of psilocybin therapy on self-reported depression (exploratory) [ Time Frame: Baseline to 3 months following last drug dose ]
    Measured using the Quality of Life in Neurological Disorders (Neuro-QoL) Depression Scale
    • Each item is scored on a scale of 1 to 5 with a total score range of 8-40
    • Higher total scores correspond to worse outcomes
  • Effects of psilocybin therapy on self-reported lower extremity function (exploratory) [ Time Frame: Baseline to 3 months following last drug dose ]
    Measured using the Quality of Life in Neurological Disorders (Neuro-QoL) Lower Extremity Function Scale
    • Each item is scored on a scale of 1 to 5 with a total score range of 8-40
    • Lower total scores correspond to worse outcomes
  • Effects of psilocybin therapy on self-reported Upper Extremity Function (exploratory) [ Time Frame: Baseline to 3 months following last drug dose ]
    Measured using the Quality of Life in Neurological Disorders (Neuro-QoL) Upper Extremity Function Scale
    • Each item is scored on a scale of 1 to 5 with a total score range of 8-40
    • Lower total scores correspond to worse outcomes
  • Effects of psilocybin therapy on self-reported Cognitive Function (exploratory) [ Time Frame: Baseline to 3 months following last drug dose ]
    Measured using the Quality of Life in Neurological Disorders (Neuro-QoL) Cognitive Function Scale
    • Each item is scored on a scale of 1 to 5 with a total score range of 8-40
    • Lower total scores correspond to worse outcomes
  • Effects of psilocybin therapy on self-reported Fatigue (exploratory) [ Time Frame: Baseline to 3 months following last drug dose ]
    Measured using the Quality of Life in Neurological Disorders (Neuro-QoL) Fatigue Scale
    • Each item is scored on a scale of 1 to 5 with a total score range of 8-40
    • Higher total scores correspond to worse outcomes
  • Effects of psilocybin therapy on self-reported Concern with Death and Dying (exploratory) [ Time Frame: Baseline to 3 months following last drug dose ]
    Measured using the Quality of Life in Neurological Disorders (Neuro-QoL) Concern with Death and Dying Scale
    • Each item is scored on a scale of 1 to 5 with a total score range of 6-35
    • Higher total scores correspond to worse outcomes
  • Effects of psilocybin therapy on self-reported Social Roles and Activities (exploratory) [ Time Frame: Baseline to 3 months following last drug dose ]
    Measured using the Quality of Life in Neurological Disorders (Neuro-QoL) Social Roles and Activities Scale
    • Each item is scored on a scale of 1 to 5 with a total score range of 8-40
    • Lower total scores correspond to worse outcomes
  • Effects of psilocybin therapy on self-reported Positive Affect and Well-Being (exploratory) [ Time Frame: Baseline to 3 months following last drug dose ]
    Measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Positive Affect and Well-Being Scale
    • Each item is scored on a scale of 1 to 5 with a total score range of 7-45
    • Lower total scores correspond to worse outcomes
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Psilocybin Therapy for Depression and Anxiety in Parkinson's Disease
Official Title  ICMJE Psilocybin Therapy for Depression and Anxiety in Parkinson's Disease: a Pilot Study
Brief Summary 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.
Detailed Description 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 ten people ages 40 to 75 with clinically diagnosed early stage Parkinson's Disease 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 with trained facilitators followed by an initial drug administration session during which they will receive a low-moderate dose (10 mg) oral psilocybin in a supervised setting with safety monitoring by facilitators and a physician. Participants who do not experience significant adverse events during or following the session will complete a second drug administration session approximately two weeks later during which they will receive a moderate-high dose (25 mg) oral psilocybin. The second session will involve the same procedures and level of monitoring as the first. Participants will subsequently complete multiple follow-up sessions to assess PD motor symptoms, non-motor symptoms, and function. They will also complete integration sessions with facilitators to provide psychological support. 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/quality of life.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Parkinson Disease
  • Depression
  • Anxiety
Intervention  ICMJE 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
Other Name: 4-phosphoryloxy-N,N-dimethyltryptamine
Study Arms  ICMJE Experimental: Psilocybin therapy
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.
Intervention: Drug: Psilocybin therapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 11, 2021)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 40 to 75
  • Comfortable speaking and writing in English
  • 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
  • Currently experiencing depression and/or anxiety (a formal diagnosis is not necessary)
  • Able to attend all in-person visits at UCSF as well as virtual visits
  • Have a care partner/support person available throughout the study
  • Have an established primary care provider, neurologist, or psychiatrist

Exclusion Criteria:

  • Psychotic symptoms involving loss of insight
  • Significant cognitive impairment
  • Regular use of medications that may have problematic interactions with psilocybin, including but not limited to dopamine agonists, MAO inhibitors, N-methyl-D-aspartate (NMDAR) antagonists, antipsychotics, and stimulants
  • A health condition that makes this study unsafe or unfeasible, determined by study physicians
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Zach Busby 415-881-8273 psilocybinstudies@ucsf.edu
Contact: Ellen Bradley, MD ellen.bradley@ucsf.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04932434
Other Study ID Numbers  ICMJE 20-32641
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Joshua Woolley, MD/PhD, University of California, San Francisco
Study Sponsor  ICMJE Joshua Woolley, MD/PhD
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Joshua Woolley, MD/PhD University of California, San Francisco
Study Director: Ellen Bradley, MD University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP