A Two-Year Observational Follow-up Study of Subjects With Major Depressive Disorder Following a Randomized, Double-Blind Single-Dose of Psilocybin or Niacin-Control

This is a Phase 2 double-blind, long-term observational follow-up study of participants from Study PSIL201.

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Status Enrolling by invitation
Start date 01 April 2020
End date 01 October 2022
Chance of happening 100%
Design Open
Type Observational
Generation First
Participants 80
Sex All
Age 21- 65
Therapy No

Trial Details

Participants providing informed consent will be enrolled into this study and will complete web surveys and telephone interviews conducted by one central site at the following time intervals: months 2, 3, 4, 5 and 6 (± 7 days for each assessment) and months 8, 10, 12, 14, 16, 18, 20, 22 and 24 (± 14 days for each assessment).

NCT Number NCT04353921

Sponsors & Collaborators

Utrecht University
Some researchers at Utrecht University are working on a large psychedelics study with colleagues from Leiden University, but this university hasn't set up any department specifically for psychedelic studies.

Measures Used

Montgomery-Asberg Depression Rating Scale
A ten-item diagnostic questionnaire used to measure the severity of depressive symptoms in patients with mood disorders.

Data attribution

A large set of the trials in our database are sourced from ClinicalTrials.gov (CTG). We have modified these post to display the information in a more clear format or to correct spelling mistakes. Our database in actively updated and may show a different status (e.g. completed) if we have knowledge of this update (e.g. a published paper on the study) which isn't reflected yet on CTG. If a trial is not sourced from CTG, this is indicated on this page and you can follow the link to the alternative source of information.
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