Psilocybin for depression
ISRCTN | ISRCTN14426797 |
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DOI | https://doi.org/10.1186/ISRCTN14426797 |
EudraCT/CTIS number | 2013-003196-35 |
Secondary identifying numbers | Version 7 |
- Submission date
- 30/03/2015
- Registration date
- 07/07/2015
- Last edited
- 12/01/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
Depression affects people in different ways and can cause a wide variety of symptoms. They range from lasting feelings of sadness and hopelessness (low mood), to feeling very tearful at unexpected moments (emotional lability). Many people with depression also have symptoms of anxiety. Treatment for depression involves either medication or talking treatments, but these do not work for everybody because some people have depression that is treatment-resistant. Psilocybin is a hallucinogenic drug that comes from what is often called ‘magic mushrooms’. The drug can put some people in a euphoric mood for a number of hours and reduce anxiety. Psilocybin has been given to healthy volunteers and to patients suffering from Obsessive Compulsive Disorder (OCD) and anxiety before with positive results, but it has not been tested in depression. The aim of this initial study is to investigate how this drug works on patients with treatment-resistant depression. We also want to find out which dose gives predictable results in improving peoples’ mood.
Who can participate?
Patients referred from local London psychiatric teams.
What does the study involve?
The potential psychological effects of psilocybin are fully described to all patients before they sign up for the study. Participants are made to feel very prepared for their experience before taking the drug and are taught ways to relax to reduce anxiety and promote a positive drug experience. Patients receive a low dose in the first session so that they have a first impression of the drug experience before moving on to a higher dose. People can respond to the drug very differently from one another and some may not want to take the higher dose. A positive environment is created during the study so that participants feel relaxed and don’t feel worried. The study team has a psychiatrist and psychotherapist and all dosing sessions are supervised by a medical doctor. Follow-up meetings take place after each dosing session and any bad feelings experienced by participants will be managed by the study psychiatrist, GPs and/or community mental health professionals.
What are the possible benefits and risks of participating?
Bad side effects are rare when psilocybin is taken by healthy volunteers but they may be more likely in vulnerable patients such as those with depression. Risks include anxiety, ‘bad trips’ (dysphoria) and rarer psychotic responses. We will minimise risks by excluding patients experiencing psychotic symptoms at the time of the study, or those who have a personal/family history of psychosis. The occurrence of negative feelings experienced by people taking psilocybin depends on the dose amount so the maximum dose we give is considered moderate in healthy volunteers.
Where is the study run from?
Imperial Clinical Research Facility, Hammersmith Hospital (UK)
When is the study starting and how long is it expected to run for?
April 2015 to December 2015
Who is funding the study?
Medical Research Council (UK)
Who is the main contact?
Dr R Carhart-Harris (UK)
Contact information
Scientific
Burlington Danes Building, Du Cane Rd
London
W10 5NA
United Kingdom
Study information
Study design | Open label design |
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Primary study design | Interventional |
Secondary study design | Non randomised study |
Study setting(s) | Other |
Study type | Treatment |
Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
Scientific title | Assessing the subjective intensity of oral PSILOcybin in patients with treatment-resistant DEPression: a PILOT study |
Study acronym | PSILODEP-PILOT |
Study hypothesis | Psilocybin will reduce symptoms of depression in patients diagnosed with treatment-resistant depression. |
Ethics approval(s) | NRES London West London, 03/09/2014, ref: 13/LO/1224 |
Condition | Major depression |
Intervention | Two doses of psilocybin 10mg and 25mg per so, separated by one week |
Intervention type | Drug |
Pharmaceutical study type(s) | |
Phase | Phase II |
Drug / device / biological / vaccine name(s) | Psilocybin |
Primary outcome measure | Quick Inventory of Depressive Symptoms (QIDS) questionnaire at start of trial, then one day and one week post-psilocybin. QIDS is a self-report measure of depressive symptoms |
Secondary outcome measures | 1. Beck Depression Inventory (BDI) questionnaire 2. Hamilton Depression Rating Scale (HAM-D) questionnaire 3. Montgomery–Åsberg Depression Rating Scale (MADRS) questionnaire |
Overall study start date | 21/04/2015 |
Overall study end date | 01/12/2015 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 12 |
Participant inclusion criteria | 1. Major depression of a moderate to severe degree (17+ on the 21-item HAM-D) 2. No improvement despite two courses of antidepressant treatment for adequate duration (6 weeks minimum) within current episode 3. No magnetic resonance imaging (MRI) contraindications |
Participant exclusion criteria | 1. Current or previously diagnosed psychotic disorder 2. Immediate family member with a diagnosed psychotic disorder 3. Medically significant condition rendering unsuitability for the study (e.g., diabetes, epilepsy, severe cardiovascular disease, hepatic or renal failure etc) 4. History of suicide attempts 5. History of mania 6. Blood or needle phobia 7. Positive pregnancy test at screening or during the study 8. Current drug or alcohol dependence 9. Allergy to gelatine or lactose 10. Lack of appropriate use of contraception 11. Breastfeeding |
Recruitment start date | 21/04/2015 |
Recruitment end date | 01/12/2015 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
London
W10 5NA
United Kingdom
Sponsor information
University/education
Burlington Danes Building
Du Cane Rd
London
W10 5NA
England
United Kingdom
https://ror.org/041kmwe10 |
Funders
Funder type
Research council
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
Intention to publish date | 01/12/2016 |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Stored in repository |
Publication and dissemination plan | We intend to analyse the results with a view to publication in peer-reviewed scientific press. The first study report will be prepared after 01/12/2015. |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | results | 01/07/2016 | Yes | No | |
Results article | results | 17/01/2018 | Yes | No | |
Results article | results | 01/11/2018 | Yes | No | |
Results article | results | 01/02/2020 | 12/01/2021 | Yes | No |
HRA research summary | 28/06/2023 | No | No |
Editorial Notes
12/01/2021: Publication reference added.
14/02/2018: Publication references added.
24/05/2016: Publication reference added.
The registration was initiated on 30/03/2015 and finalised on 07/07/2015. The recruitment started on 21/04/2015, after initiation of public registration.