Psilocybin vs Escitalopram for Major Depressive Disorder: Comparative Mechanisms

Depressive Disorder, Major Clinical Trial

— Psilodep-RCT  

Official title:

Psilocybin vs Escitalopram for Major Depressive Disorder: Comparative Mechanisms

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03429075
• Other study ID #: 17HH3790
• Secondary ID: 2017-000219-18
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: January 7, 2019
• Est. completion date: October 2020

Study information

• Verified date: July 2020
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 59
• Est. completion date: October 2020
• Est. primary completion date: April 17, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease

Intervention

Drug:
• Psilocybin + Placebo
Multiple dosing days psilocybin vs 6 weeks of daily placebo
• Psilocybin + Escitalopram
Multiple dosing days psilocybin vs 6 weeks of daily escitalopram

Locations

Country	Name	City	State
United Kingdom	Imperial College Hammersmith campus	London

Sponsors (2)

Lead Sponsor	Collaborator
Imperial College London	Alexander Mosely Charitable Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	functional magnetic resonance imaging (fMRI)	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.	Baseline measure vs 6 weeks post 1st psilocybin dosing
Secondary	Quick Inventory of Depressive Symptomatology (QIDS-SR16)	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	Baseline vs 6 weeks post 1st psilocybin dosing