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Psilocybin vs Escitalopram for Major Depressive Disorder: Comparative Mechanisms (Psilodep-RCT)

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ClinicalTrials.gov Identifier: NCT03429075
Recruitment Status : Unknown
Verified July 2020 by Imperial College London.
Recruitment status was:  Active, not recruiting
First Posted : February 12, 2018
Last Update Posted : July 31, 2020
Alexander Mosely Charitable Trust
Information provided by (Responsible Party):
Imperial College London

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

Condition or disease Intervention/treatment Phase
Depressive Disorder, Major Drug: Psilocybin + Placebo Drug: Psilocybin + Escitalopram Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Psilocybin vs Escitalopram for Major Depressive Disorder: Comparative Mechanisms
Actual Study Start Date : January 7, 2019
Actual Primary Completion Date : April 17, 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Psilocybin
Patients receive Psilocybin
Drug: Psilocybin + Placebo
Multiple dosing days psilocybin vs 6 weeks of daily placebo

Active Comparator: Escitalopram
Patients receive Escitalopram
Drug: Psilocybin + Escitalopram
Multiple dosing days psilocybin vs 6 weeks of daily escitalopram

Primary Outcome Measures :
  1. functional magnetic resonance imaging (fMRI) [ Time Frame: Baseline measure vs 6 weeks post 1st psilocybin dosing ]
    Change in blood oxygen level dependent (BOLD) signal during fMRI in response to emotional faces during an emotional faces paradigm done inside the fMRI scanner.

Secondary Outcome Measures :
  1. Quick Inventory of Depressive Symptomatology (QIDS-SR16) [ Time Frame: Baseline vs 6 weeks post 1st psilocybin dosing ]
    Change in QIDS-SR16 (self-rated measure of depressive symptoms). Scale is composed of 16 items that correlate with the 9 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03429075

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United Kingdom
Imperial College Hammersmith campus
London, United Kingdom, W12 0NN
Sponsors and Collaborators
Imperial College London
Alexander Mosely Charitable Trust
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Principal Investigator: David J Nutt, Medicine Imperial College London
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT03429075    
Other Study ID Numbers: 17HH3790
2017-000219-18 ( EudraCT Number )
First Posted: February 12, 2018    Key Record Dates
Last Update Posted: July 31, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Imperial College London:
major depression
major depressive disorder
unipolar depression
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs