Assessing the subjective intensity of oral psilocybin in patients with treatment-resistant depressio

Phase 1

• Conditions: Major depressive disorder; MedDRA version: 18.0 Level: PT Classification code 10057840 Term: Major depression System Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2013-003196-35-GB
• Lead Sponsor: Imperial College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-07-01
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 12

Inclusion Criteria

Treatment resistant major depressive disorder, DSM-IV
(i.e. depression which has failed to respond to at least 2 courses of antidepressant treatment of different class)
18+ yrs of age
Males and females
17+ on the HAM-D

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 12
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: How sensitive are patients with depression to the subjective effects of psilocybin?;<br> Secondary Objective: Can we identify changes in brain activity pre (6 days pre session 1) and post (next day after session 2) treatment using functional MRI?<br><br> ;Primary end point(s): Ratings of the intensity of the subjective effects of psilocybin ;Timepoint(s) of evaluation of this end point: Peak drug effects

Secondary Outcome Measures

Name	Time	Method
<br> Secondary end point(s): Changes in brain activity, i.e. blood flow and resting-state functional connectivity, post versus pre treatment.<br><br> ;Timepoint(s) of evaluation of this end point: One day post-second treatment session ('post') versus 6 days prior to first session ('pre').