Psilocybin vs Escitalopram for Major Depressive Disorder: Comparative Mechanisms

Imperial College London59 enrolled

Overview

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 serotonin reuptake inhibitor (SSRI) escitalopram for major depressive disorder (MDD).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Depressive Disorder, Major

Interventions

Psilocybin + PlaceboDRUG

Multiple dosing days psilocybin vs 6 weeks of daily placebo

Psilocybin + EscitalopramDRUG

Multiple dosing days psilocybin vs 6 weeks of daily escitalopram

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Major depressive disorder (DSM-IV) 2. Depression of moderate to severe degree (17+ on the 17-item Hamilton Depression Scale (HAM-D)). 3. No Magnetic Resonance Imaging (MRI) contraindications 4. No SSRI contraindications 5. Has a general practitioner (GP) or other mental healthcare professional who can confirm diagnosis 6. 18-80 years of age 7. Males and females 8. Sufficiently competent with English language Key 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 e.g. creatine clearance:renal clearance (CLRC) \< 30 ml/min etc.) 4. History of serious suicide attempts requiring hospitalisation. 5. Significant history of mania (determined by study psychiatrist and medical records) 6. Psychiatric condition judged to be incompatible with establishment of rapport with therapy team and/or safe exposure to psilocybin, e.g. borderline personality disorder 7. Blood or needle phobia 8. Positive pregnancy test at screening or during the study, women who are planning a pregnancy and/or women who are nursing/breastfeeding. 9. Participants who do not agree to use an acceptable contraceptive method throughout their participation in study. 10. Current drug or alcohol dependence 11. No email access 12. Use of contraindicated medication 13. 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)

Locations (1)

Imperial College Hammersmith campus

London, United Kingdom

Outcomes

Primary Outcomes

Percentage Change of the BOLD Signal

Patients were tested with functional magnetic resonance imaging (fMRI) to measure brain brain responses to emotional faces before and after the treatment. The 2 values of BOLD signal (before and after exposure to emotional faces) were used to estimate a percentage value per patient and then these were used to estimated a group percentage change.

Time frame: Baseline measure vs 6 weeks post 1st psilocybin dosing

Change in QIDS-16: Quick Inventory of Depressive Symptomatology Self-Rated (QIDS-16)

Change in QIDS-16 (self-rated measure of depressive symptoms). Scale is composed of 16 items that correlate with the 9 Diagnostic Statistical Manual (DSM-IV) symptom criteria for depression. Each response is graded 0-4 (none-severe symptoms). Questions 1-4 concern sleep disturbances, Question 5 addresses sad mood, Questions 6-9 appetite/weight, Question 10 concentration, Question 11 self-criticism, Question 12 suicidal ideation, Question 13 interest, Q14 energy/fatigue and Questions 15-16 psychomotor agitation/retardation. All questions that address the same topic are grouped and only the highest score from each group is summed up together with the other questions in order to produce a total score. Scores can range from 0-27 and depression severity is graded based on the total score in the following way: 1-5 = No depression 6-10 = Mild depression 11-15 = Moderate depression 16-20 = Severe depression 21-27 = Very severe depression Lower score =better outcome (less depression)

Time frame: Baseline vs 6 weeks post 1st psilocybin dosing

Secondary Outcomes

Change in Hamilton Depression Scale (HAMD-17)

HAMD-17: clinician rated Hamilton Depression Scale of depression severity. Range of scores: 0-52: where 0-7 is normal, 8-16 is mild, 17-23 is moderate, \>23 is severe. A threshold score of 17 is the entry: a score of 17 or higher indicated moderate-severe depression and was a requirement for entry into this trial at the screening point. This baseline does not refer to the screening point, it refers to the HAMD conducted 7-10 days before psilocybin dosing. A higher decrease in the HAMD (larger negative change score) is a better outcome.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.