Clinical Trial Results:
A randomised, placebo controlled trial of psilocybin in treatment resistant depression: A feasibility study
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Summary
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EudraCT number |
2018-003573-97 |
Trial protocol |
GB |
Global end of trial date |
28 Aug 2025
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Results information
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Results version number |
v1(current) |
This version publication date |
26 Sep 2026
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First version publication date |
26 Sep 2026
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Other versions |
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Summary report(s) |
PsiDeR_Clinical_Study Report |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
PSIDER
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT04959253 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
King's College London
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Sponsor organisation address |
F16 Guy's Tower, Guy's Hospital, Great Maze Pond,, London , United Kingdom,
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Public contact |
Prof. Allan Young, King's College London, +44 02078480088, allan.young@kcl.ac.uk
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Scientific contact |
Prof. Allan Young, King's College London, +44 02078480088, allan.young@kcl.ac.uk
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Sponsor organisation name |
South London & Maudsley NHS Foundation Trust
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Sponsor organisation address |
Maudsley Hospital, Denmark Hill, London , United Kingdom,
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Public contact |
Prof. Allan Young, South London & Maudsley NHS Foundation Trust, 020 78480088, allan.young@kcl.ac.uk
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Scientific contact |
Prof. Allan Young, South London & Maudsley NHS Foundation Trust, 020 78480088, allan.young@kcl.ac.uk
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
28 Aug 2025
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
18 Dec 2024
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Global end of trial reached? |
Yes
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Global end of trial date |
28 Aug 2025
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To evaluate the feasibility of a randomised, controlled trial design, in which a single dose of psilocybin 25mg PO vs placebo, is given to adult participants with treatment resistant major depressive disorder (TRD), under psychologically supportive conditions, with 6 weeks of follow up, by measuring recruitment rates, dropout rates and by estimating the variance of the primary outcome measure (MADRS) to inform upon the design of a phase 3 trial.
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Protection of trial subjects |
Participants have the right to withdraw from the study at any time for any reason. The investigator also has the right to withdraw patients from the study drug in the event of inter-current illness, AEs, SAE’s, SUSAR’s, protocol violations, cure, administrative reasons or other reasons. It is understood by all concerned that an excessive rate of withdrawals can render the study uninterpretable; therefore, unnecessary withdrawal of participants should be avoided. Should a participant decide to withdraw from the study, all efforts will be made to report the reason for withdrawal as thoroughly as possible and efforts will be made to continue to obtain follow-up data, if the participant consents to this. Since the treatment consists of a single dose of psilocybin, it is not practical for participants to withdraw during the Dosing Visit.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Sep 2020
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United Kingdom: 60
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Worldwide total number of subjects |
60
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EEA total number of subjects |
0
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
60
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
- | |||||||||||||||
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Pre-assignment
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Screening details |
- | |||||||||||||||
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Pre-assignment period milestones
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Number of subjects started |
60 | |||||||||||||||
Number of subjects completed |
60 | |||||||||||||||
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Period 1
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Period 1 title |
Overall Trial (overall period)
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Is this the baseline period? |
Yes | |||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||||||||
Roles blinded |
Subject, Investigator, Monitor, Carer, Assessor | |||||||||||||||
Blinding implementation details |
Both treatments were delivered in 5 identical opaque HPMC capsules. All participants and members of the study team present during the Dosing Visit were blinded to treatment allocation. Allocation concealment was maintained by the Maudsley Hospital Pharmacy. Emergency unblinding was available 24 hours per day via the on-call pharmacist. MADRS assessments were done by blinded raters who were external and independent to the study team.
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Placebo | |||||||||||||||
Arm description |
To evaluate the feasibility of a randomised, controlled trial design in which a single dose of psilocybin 25mg per os vs placebo is given to adult participants with treatment resistant major depressive disorder (TRD), under psychologically supportive conditions, with 6 weeks of follow up, by measuring recruitment rates, dropout rates and by estimating the variance of the primary outcome measure (MADRS) to inform the design of a Phase 3 trial. Matching placebo (5 × 5mg HPMC capsules, Starch 1500 only) | |||||||||||||||
Arm type |
Placebo | |||||||||||||||
Investigational medicinal product name |
Psilocybin
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
Psilocybin 25mg, single oral dose (5 × 5mg HPMC capsules)
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Arm title
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Psilocybin | |||||||||||||||
Arm description |
Psilocybin 25mg, single oral dose (5 × 5mg HPMC capsules) | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
Psilocybin
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
Psilocybin 25mg, single oral dose (5 × 5mg HPMC capsules)
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Baseline characteristics reporting groups
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Reporting group title |
Placebo
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Reporting group description |
To evaluate the feasibility of a randomised, controlled trial design in which a single dose of psilocybin 25mg per os vs placebo is given to adult participants with treatment resistant major depressive disorder (TRD), under psychologically supportive conditions, with 6 weeks of follow up, by measuring recruitment rates, dropout rates and by estimating the variance of the primary outcome measure (MADRS) to inform the design of a Phase 3 trial. Matching placebo (5 × 5mg HPMC capsules, Starch 1500 only) | ||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Psilocybin
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Reporting group description |
Psilocybin 25mg, single oral dose (5 × 5mg HPMC capsules) | ||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Placebo
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Reporting group description |
To evaluate the feasibility of a randomised, controlled trial design in which a single dose of psilocybin 25mg per os vs placebo is given to adult participants with treatment resistant major depressive disorder (TRD), under psychologically supportive conditions, with 6 weeks of follow up, by measuring recruitment rates, dropout rates and by estimating the variance of the primary outcome measure (MADRS) to inform the design of a Phase 3 trial. Matching placebo (5 × 5mg HPMC capsules, Starch 1500 only) | ||
Reporting group title |
Psilocybin
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Reporting group description |
Psilocybin 25mg, single oral dose (5 × 5mg HPMC capsules) | ||
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End point title |
Feasibility Parameters [1] | ||||||||||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Baseline to week 6 follow-up
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Please see uploaded report. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
Since the IMP does not have a license or SmPC, all adverse events will be reported. Adverse events will be reported from the start of Dosing Visit (V3) until completion of follow up or until the end of the open label extension if the participant
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
26.1
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Reporting groups
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Reporting group title |
Placebo
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Reporting group description |
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Reporting group title |
Psilocybin
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Reporting group description |
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| Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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27 Aug 2020 |
MHRA: protocol 1.13 REC/HRA: protocol v1.10 Clinician Info v1.0, PIS Main v1.0, ICF Main v1.0, ICF Neuro v1.0, ICF OLE v1.0, participant advert v1.0, PIS Neuro v1.0, PIS OLE v1.0, On-line screening questionnaire. IB v6.0 27Nov19 |
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12 May 2022 |
The protocol now clarifies the logistical arrangements between the main trial and the open-label extension. The schedule of visits has been updated to allow a window of up to 5 weeks between visits V7/OLE1 and OLE2, when and where logistically necessary and the allowable window for all follow-up visits is now relative to visit OLE2.
Protocol v1.16, PIS Main v1.24, PIS OLE v1.11 & ICF main v1.11, ICF OLE v1.11 (minor changes to all). IB v7.1 05Jan21 |
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12 Mar 2024 |
The Investigator Brochure has been updated with administrative and trial-related data revisions. The RSI in the IB has not been altered. No significant new safety findings for COMP360 have been identified.
IB v9.0 & IB v10 |
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18 Oct 2024 |
The IB was updated with administrative and trial-related data revisions. The RSI in the IB has not been altered but some significant new safety findings for COMP360 have been identified. The protocol was updated with the new sponsor contact details.
IB v10.1 & IB v11.0 / Protocol v1.21 |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
Online references |
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| http://www.ncbi.nlm.nih.gov/pubmed/34853114 |
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