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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ISRCTN
Last refreshed on:	25 January 2021
Main ID:	ISRCTN14426797
Date of registration:	07/07/2015
Prospective Registration:	No
Primary sponsor:	Imperial College London
Public title:	Psilocybin for depression
Scientific title:	Assessing the subjective intensity of oral PSILOcybin in patients with treatment-resistant DEPression: a PILOT study
Date of first enrolment:	21/04/2015
Target sample size:	12
Recruitment status:	Completed
URL:	http://isrctn.com/ISRCTN14426797
Study type:	Interventional
Study design:	Open label design (Treatment)
Phase:	Phase II

Countries of recruitment
United Kingdom

Contacts

Name:	Robin Carhart-Harris
Address:	Burlington Danes Building, Du Cane Rd W10 5NA London United Kingdom
Telephone:
Email:
Affiliation:

Name:
Address:
Telephone:
Email:
Affiliation:

Key inclusion & exclusion criteria

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

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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Major depression
Mental and Behavioural Disorders
Depression

Intervention(s)

Two doses of psilocybin 10mg and 25mg per so, separated by one week

Primary Outcome(s)

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(s)

1. Beck Depression Inventory (BDI) questionnaire
2. Hamilton Depression Rating Scale (HAM-D) questionnaire
3. Montgomery–Åsberg Depression Rating Scale (MADRS) questionnaire

Secondary ID(s)

Version 7

2013-003196-35

Source(s) of Monetary Support

Medical Research Council

Secondary Sponsor(s)

Ethics review

Status:
Approval date:
Contact:

NRES London West London, 03/09/2014, ref: 13/LO/1224

Results

Results available:	Yes
Date Posted:
Date Completed:	01/12/2015
URL:

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