Status:
COMPLETED
Psilocybin vs Escitalopram for Major Depressive Disorder: Comparative Mechanisms
Lead Sponsor:
Imperial College London
Collaborating Sponsors:
Alexander Mosely Charitable Trust
Conditions:
Depressive Disorder, Major
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
This is a randomised double-blind clinical trial. The aim is to compare the efficacy and mechanisms of action of psilocybin, the primary psychoactive substance in 'magic mushrooms', with the selective...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Major depressive disorder (DSM-IV)
- Depression of moderate to severe degree (17+ on the 17-item Hamilton Depression Scale (HAM-D)).
- No Magnetic Resonance Imaging (MRI) contraindications
- No SSRI contraindications
- Has a general practitioner (GP) or other mental healthcare professional who can confirm diagnosis
- 18-80 years of age
- Males and females
- Sufficiently competent with English language
- Key exclusion criteria:
- Current or previously diagnosed psychotic disorder
- Immediate family member with a diagnosed psychotic disorder
- Medically significant condition rendering unsuitability for the study (e.g., diabetes, epilepsy, severe cardiovascular disease, hepatic or renal failure e.g. creatine clearance:renal clearance (CLRC) \< 30 ml/min etc.)
- History of serious suicide attempts requiring hospitalisation.
- Significant history of mania (determined by study psychiatrist and medical records)
- Psychiatric condition judged to be incompatible with establishment of rapport with therapy team and/or safe exposure to psilocybin, e.g. borderline personality disorder
- Blood or needle phobia
- Positive pregnancy test at screening or during the study, women who are planning a pregnancy and/or women who are nursing/breastfeeding.
- Participants who do not agree to use an acceptable contraceptive method throughout their participation in study.
- Current drug or alcohol dependence
- No email access
- Use of contraindicated medication
- Patients presenting with abnormal QT interval prolongation at screening or with a history of this (QTc at screening above 440ms for men and above 470ms for women)
Exclusion
Key Trial Info
Start Date :
January 7 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 17 2020
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT03429075
Start Date
January 7 2019
End Date
October 17 2020
Last Update
October 24 2024
Active Locations (1)
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1
Imperial College Hammersmith campus
London, United Kingdom, W12 0NN