Psilocybin Therapy for Depression and Anxiety in Parkinson's Disease

NCT04932434 | Completed Phase 2 FDA Drug

• 1 other identifier: 20-32641
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease; Depression; Anxiety

Keywords

Parkinson Disease; Depression; Anxiety; Psilocybin; Psilocybin therapy; Movement disorder

Outcome Measures

Primary Outcomes (11)

• Parkinson's Disease (PD) symptom severity

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

  Baseline to 30 days following last drug dose

• Suicide Risk

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

  Baseline to 30 days following last drug dose

• Psychotic symptoms

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

  Baseline to 30 days following last drug dose

• Psychotic symptoms

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

  Baseline to 30 days following last drug dose

• Cognitive Safety

  Measured by Cambridge Neuropsychological Test Automated Battery (CANTAB)

  Baseline to 30 days following last drug dose

• Caregiver/support person-reported distress

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

  Baseline to 90 days following last drug dose

• Participant-reported subjective experience

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

  Measured on each drug administration session day, following drug dose

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

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

  Baseline to 3 months following last drug dose

• Recruitment rate

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

  Baseline to 3 months following last drug dose

• 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 recruited

  Baseline to 3 months following last drug dose

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

  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

  Baseline to 3 months following last drug dose

Other Outcomes (7)

• Effects of psilocybin therapy on depression in people with PD (exploratory)

  Baseline to 3 months following last drug dose

• Effects of psilocybin therapy on anxiety in people with PD (exploratory)

  Baseline to 3 months following last drug dose

• Cognitive Flexibility

  Baseline to 30 days following last drug dose

Study Arms (1)

Psilocybin therapy

EXPERIMENTAL

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

Interventions

Psilocybin therapy DRUG

* 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

Psilocybin therapy

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 40 to 75
• Comfortable speaking and writing in English

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Joshua Woolley, MD, PhD: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Related Publications (7)

• GBD 2016 Parkinson's Disease Collaborators. Global, regional, and national burden of Parkinson's disease, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2018 Nov;17(11):939-953. doi: 10.1016/S1474-4422(18)30295-3. Epub 2018 Oct 1.

  PMID: 30287051 BACKGROUND

• Weintraub D, Burn DJ. Parkinson's disease: the quintessential neuropsychiatric disorder. Mov Disord. 2011 May;26(6):1022-31. doi: 10.1002/mds.23664.

  PMID: 21626547 BACKGROUND

• Maillet A, Krack P, Lhommee E, Metereau E, Klinger H, Favre E, Le Bars D, Schmitt E, Bichon A, Pelissier P, Fraix V, Castrioto A, Sgambato-Faure V, Broussolle E, Tremblay L, Thobois S. The prominent role of serotonergic degeneration in apathy, anxiety and depression in de novo Parkinson's disease. Brain. 2016 Sep;139(Pt 9):2486-502. doi: 10.1093/brain/aww162. Epub 2016 Aug 17.

  PMID: 27538418 BACKGROUND

• Schapira AHV, Chaudhuri KR, Jenner P. Non-motor features of Parkinson disease. Nat Rev Neurosci. 2017 Jul;18(7):435-450. doi: 10.1038/nrn.2017.62. Epub 2017 Jun 8.

  PMID: 28592904 BACKGROUND

• Weintraub D, Moberg PJ, Duda JE, Katz IR, Stern MB. Effect of psychiatric and other nonmotor symptoms on disability in Parkinson's disease. J Am Geriatr Soc. 2004 May;52(5):784-8. doi: 10.1111/j.1532-5415.2004.52219.x.

  PMID: 15086662 BACKGROUND

• Barone P, Antonini A, Colosimo C, Marconi R, Morgante L, Avarello TP, Bottacchi E, Cannas A, Ceravolo G, Ceravolo R, Cicarelli G, Gaglio RM, Giglia RM, Iemolo F, Manfredi M, Meco G, Nicoletti A, Pederzoli M, Petrone A, Pisani A, Pontieri FE, Quatrale R, Ramat S, Scala R, Volpe G, Zappulla S, Bentivoglio AR, Stocchi F, Trianni G, Dotto PD; PRIAMO study group. The PRIAMO study: A multicenter assessment of nonmotor symptoms and their impact on quality of life in Parkinson's disease. Mov Disord. 2009 Aug 15;24(11):1641-9. doi: 10.1002/mds.22643.

  PMID: 19514014 BACKGROUND

• Ishihara L, Brayne C. A systematic review of depression and mental illness preceding Parkinson's disease. Acta Neurol Scand. 2006 Apr;113(4):211-20. doi: 10.1111/j.1600-0404.2006.00579.x.

  PMID: 16542159 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease; Depression; Anxiety Disorders; Movement Disorders

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Synucleinopathies; Neurodegenerative Diseases; Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Joshua Woolley, MD/PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Ellen Bradley, MD

  University of California, San Francisco

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: Single Group Assignment

Study Record Dates

• First Submitted: May 5, 2021
• First Posted: June 21, 2021
• Study Start: August 15, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: January 1, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)