Clinical Trial Results:
Assessing the subjective intensity of oral psilocybin in patients with treatment-resistant depression: A Pilot Study
Summary
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EudraCT number |
2013-003196-35 |
Trial protocol |
GB |
Global end of trial date |
27 Sep 2016
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Results information
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Results version number |
v1(current) |
This version publication date |
03 Jan 2020
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First version publication date |
03 Jan 2020
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Other versions |
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 |
13HH0762
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Additional study identifiers
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ISRCTN number |
ISRCTN14426797 | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Other trial identifiers |
REC: 13/LO/1224 , MRC: MR/J00460X/1 | ||
Sponsors
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Sponsor organisation name |
Imperial College London
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Sponsor organisation address |
Exhibition Road, London, United Kingdom, SW7 2AZ
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Public contact |
Carhart-Harris, Robin, Imperial College London, 44 02075946550, r.carhart-harris@imperial.ac.uk
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Scientific contact |
Carhart-Harris, Robin, Imperial College London, 44 02075946550, r.carhart-harris@imperial.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 |
13 Jul 2017
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
27 Sep 2016
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Global end of trial reached? |
Yes
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Global end of trial date |
27 Sep 2016
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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 |
How sensitive are patients with depression to the subjective effects of psilocybin?
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Protection of trial subjects |
24-hour contact number to study psychiatrist
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
05 Jan 2015
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Long term follow-up planned |
Yes
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Long term follow-up rationale |
Scientific research | ||
Long term follow-up duration |
6 Months | ||
Independent data monitoring committee (IDMC) involvement? |
No
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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: 20
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Worldwide total number of subjects |
20
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EEA total number of subjects |
20
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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) |
20
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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 |
Most recruitment happened through self-referrals and also through the Clinical Research Network. Patients first had a telephone screening and if they appeared suitable came in for a face-to-face screening. 120 subjects applied, 74 were telephone screened, 29 did a face-to-face screening. 20 were enrolled, 19 completed. | ||||||||||
Pre-assignment
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Screening details |
Inclusion: Major depression moderate-severe (HAMD 17+) and no response to at least 2 full courses of treatment within current episode. Exclusion: history of psychosis and family members with psychosis, medically significant conditions, history of suicide attempts, needle and blood phobia, pregnancy at screening or during study, current addiction. | ||||||||||
Pre-assignment period milestones
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Number of subjects started |
20 | ||||||||||
Number of subjects completed |
20 | ||||||||||
Period 1
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Period 1 title |
Baseline fMRI and Prep
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Is this the baseline period? |
Yes | ||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||
Blinding implementation details |
NA - open label safety pilot study
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Arms
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Arm title
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All patients - baseline | ||||||||||
Arm description |
All patients were prepped for psilocybin sessions, did baseline questionnaires and fMRI. | ||||||||||
Arm type |
No intervention, run-in period | ||||||||||
Investigational medicinal product name |
No intervention
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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 |
Other use
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Dosage and administration details |
No intervention, run-in, preparation period
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Period 2
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Period 2 title |
Treatment
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Is this the baseline period? |
No | ||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||
Blinding implementation details |
NA
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Arms
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Arm title
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All patients - treatment | ||||||||||
Arm description |
Patients receive two doses of psilocybin, 1 week apart | ||||||||||
Arm type |
Experimental | ||||||||||
Investigational medicinal product name |
Psilocybin 10mg
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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 |
2x 5mg capsules = 10mg psilocybin
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Investigational medicinal product name |
Psilocybin 25mg
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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 |
5x 5mg capsules = 25mg
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Period 3
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Period 3 title |
Post-treatment follow-ups
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Is this the baseline period? |
No | ||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||
Blinding implementation details |
NA
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Arms
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Arm title
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All patients | ||||||||||
Arm description |
fmRI and remote follow-ups up to 6 months | ||||||||||
Arm type |
all, no arms | ||||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Baseline characteristics reporting groups
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Reporting group title |
Baseline fMRI and Prep
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Reporting group description |
- | |||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
All patients - baseline
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Reporting group description |
All patients were prepped for psilocybin sessions, did baseline questionnaires and fMRI. | ||
Reporting group title |
All patients - treatment
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Reporting group description |
Patients receive two doses of psilocybin, 1 week apart | ||
Reporting group title |
All patients
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Reporting group description |
fmRI and remote follow-ups up to 6 months |
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End point title |
Quick Inventory of Depressive Symptomatology (QIDS-16) | |||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Baseline vs 5 weeks post treatment
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Statistical analysis title |
two-tailed paired t-test (Bonferroni corrected) | |||||||||
Comparison groups |
All patients - baseline v All patients
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Number of subjects included in analysis |
38
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Analysis specification |
Pre-specified
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Analysis type |
other | |||||||||
P-value |
< 0.001 | |||||||||
Method |
t-test, 2-sided | |||||||||
Confidence interval |
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End point title |
Beck Depression Inventory (BDI) | |||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Baseline vs 1 week post-treatment
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Statistical analysis title |
two-tailed paired t-test (Bonferroni corrected) | |||||||||
Comparison groups |
All patients - baseline v All patients
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Number of subjects included in analysis |
38
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Analysis specification |
Pre-specified
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Analysis type |
other | |||||||||
P-value |
< 0.001 | |||||||||
Method |
t-test, 2-sided | |||||||||
Confidence interval |
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End point title |
State Trait Anxiety Inventory - Trait (STAI-T) | |||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Baseline vs 1 week post treatment
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Statistical analysis title |
two-tailed paired t-test (Bonferroni corrected) | |||||||||
Comparison groups |
All patients v All patients - baseline
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Number of subjects included in analysis |
38
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Analysis specification |
Pre-specified
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Analysis type |
other | |||||||||
P-value |
< 0.001 | |||||||||
Method |
t-test, 2-sided | |||||||||
Confidence interval |
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Adverse events information
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Timeframe for reporting adverse events |
just before, during and few days after psilocybin sessions
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
NK
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Reporting groups
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Reporting group title |
All patients
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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? No | |||
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. | |||
Open label safety study, no control group. | |||
Online references |
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http://www.ncbi.nlm.nih.gov/pubmed/29119217 http://www.ncbi.nlm.nih.gov/pubmed/27210031 |