Psilocybin vs escitalopram for depressio

Phase 2

Completed

• Conditions: Moderate to severe major depressive disorder (17+ HAMD); Mental and Behavioural Disorders

• Registration Number: ISRCTN10584863
• Lead Sponsor: Imperial College Joint Research Compliance Office (JRCO)

Brief Summary

2018 Interim results article in https://pubmed.ncbi.nlm.nih.gov/29119217/ (added 28/06/2022) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33852780/ (added 28/06/2022) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35411074/ Increased global integration in the brain after psilocybin therapy for depression (added 28/06/2022) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35431912/ Therapeutic Alliance and Rapport Modulate Responses to Psilocybin Assisted Therapy for Depression (added 28/06/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-09-10
• Study Completion: 2020-10-17
• Last Update Posted: 5 August 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 59

Inclusion Criteria

1. Major depressive disorder (DSM-IV)
2. Depression of moderate to severe degree (17+ on the 21-item HAM-D).
2. No MRI contraindications
3. No SSRI contraindications
4. Has a GP or other mental healthcare professional who can confirm diagnosis
5. Aged 18-80
6. 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 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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Amygdala's BOLD-response to fearful faces in fMRI emotional faces task, assessed at the baseline (1 day before first psilocybin dose) and at final follow-up (6 weeks after first psilocybin dose)