Trial | NCT03429075  Report issue

Official Title

Psilocybin vs Escitalopram for Major Depressive Disorder: Comparative Mechanisms

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    59
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 SSRI (selective serotonin reuptake inhibitor) escitalopram for major depressive disorder (MDD).
Study Started
Jan 07
2019
Primary Completion
Apr 17
2020
Study Completion
Oct 31
2020
Anticipated
Last Update
Jul 31
2020

Drug Psilocybin + Placebo

Multiple dosing days psilocybin vs 6 weeks of daily placebo

Drug Psilocybin + Escitalopram [psilocybin, escitalopram (lexapro)]

Multiple dosing days psilocybin vs 6 weeks of daily escitalopram

Psilocybin Experimental

Patients receive Psilocybin

Escitalopram Active Comparator

Patients receive Escitalopram

Criteria 

Inclusion Criteria:

Major depressive disorder (DSM-IV)
Depression of moderate to severe degree (17+ on the 21-item HAM-D).
No MRI contraindications
No SSRI contraindications
Has a GP (general practitioner) 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. 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)
No Results Posted