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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 : Not yet recruiting
First Posted : February 12, 2018
Last Update Posted : February 12, 2018
Sponsor:
Collaborator:
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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Psilocybin vs Escitalopram for Major Depressive Disorder: Comparative Mechanisms
Estimated Study Start Date : March 2018
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Psilocybin Drug: Psilocybin + Placebo
Single dose of psilocybin vs 6 weeks of daily placebo

Active Comparator: Escitalopram Drug: Psilocybin + Escitalopram
Single dose of psilocybin vs 6 weeks of daily escitalopram




Primary Outcome Measures :
  1. functional magnetic resonance imaging (fMRI) [ Time Frame: Baseline measure vs 1 week post-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 1 week post-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



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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
Criteria

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

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 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
  9. Current drug or alcohol dependence
  10. No email access
  11. Use of contraindicated medication
  12. 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


Contacts
Contact: Bruna Giribaldi 02075946550 b.cunha@imperial.ac.uk
Contact: Robin Carhart-Harris r.carhart-harris@imperial.ac.uk

Sponsors and Collaborators
Imperial College London
Alexander Mosely Charitable Trust
Investigators
Principal Investigator: David J Nutt, Medicine Imperial College London

Publications:
Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT03429075     History of Changes
Other Study ID Numbers: 17HH3790
2017-000219-18 ( EudraCT Number )
First Posted: February 12, 2018    Key Record Dates
Last Update Posted: February 12, 2018
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Imperial College London:
depression
mdd
major depression
major depressive disorder
unipolar depression
psilocybin
psychedelics
psychedelic
escitalopram
ssri

Additional relevant MeSH terms:
Depressive Disorder, Major
Disease
Depressive Disorder
Depression
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Citalopram
Dexetimide
Psilocybin
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
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Hallucinogens