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Trial record 30 of 534 for:    ESCITALOPRAM AND Disorders

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

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ClinicalTrials.gov Identifier: NCT03429075
Recruitment Status : Recruiting
First Posted : February 12, 2018
Last Update Posted : March 4, 2019
Sponsor:
Collaborator:
Alexander Mosely Charitable Trust
Information provided by (Responsible Party):
Imperial College London

Tracking Information
First Submitted Date  ICMJE December 6, 2017
First Posted Date  ICMJE February 12, 2018
Last Update Posted Date March 4, 2019
Actual Study Start Date  ICMJE January 7, 2019
Actual Primary Completion Date February 20, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 28, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 5, 2018)
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.
Change History Complete list of historical versions of study NCT03429075 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 28, 2019)
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
Original Secondary Outcome Measures  ICMJE
 (submitted: February 5, 2018)
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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Psilocybin vs Escitalopram for Major Depressive Disorder: Comparative Mechanisms
Official Title  ICMJE Psilocybin vs Escitalopram for Major Depressive Disorder: Comparative Mechanisms
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Depressive Disorder, Major
Intervention  ICMJE
  • Drug: Psilocybin + Placebo
    Multiple dosing days psilocybin vs 6 weeks of daily placebo
  • Drug: Psilocybin + Escitalopram
    Multiple dosing days psilocybin vs 6 weeks of daily escitalopram
Study Arms  ICMJE
  • Experimental: Psilocybin
    Intervention: Drug: Psilocybin + Placebo
  • Active Comparator: Escitalopram
    Intervention: Drug: Psilocybin + Escitalopram
Publications * Carhart-Harris RL, Bolstridge M, Day CMJ, Rucker J, Watts R, Erritzoe DE, Kaelen M, Giribaldi B, Bloomfield M, Pilling S, Rickard JA, Forbes B, Feilding A, Taylor D, Curran HV, Nutt DJ. Psilocybin with psychological support for treatment-resistant depression: six-month follow-up. Psychopharmacology (Berl). 2018 Feb;235(2):399-408. doi: 10.1007/s00213-017-4771-x. Epub 2017 Nov 8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 5, 2018)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2020
Actual Primary Completion Date February 20, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Bruna Giribaldi 02075946550 b.cunha@imperial.ac.uk
Contact: Robin Carhart-Harris r.carhart-harris@imperial.ac.uk
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03429075
Other Study ID Numbers  ICMJE 17HH3790
2017-000219-18 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Imperial College London
Study Sponsor  ICMJE Imperial College London
Collaborators  ICMJE Alexander Mosely Charitable Trust
Investigators  ICMJE
Principal Investigator: David J Nutt, Medicine Imperial College London
PRS Account Imperial College London
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP