Assessing psilocybin as a treatment for depressio
- Conditions
- Major Depressive DisorderMedDRA version: 20.0Level: PTClassification code 10057840Term: Major depressionSystem Organ Class: 10037175 - Psychiatric disordersTherapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2017-000219-18-GB
- Lead Sponsor
- Imperial College London
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 50
Key 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. 18-80 years of age
6. Males and females
7. Sufficiently competent with English language
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 45
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5
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 etc.)
4. History of suicide attempts requiring hospitalisation.
5. History of mania
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)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: How effective is a single dose of psilocybin for major depressive disorder against an an active gold-standard medical treatment (6-weeks of escitalopram)?;Secondary Objective: How do the relevant interventions affect brain activity and can brain measures be used to predict treatment response?<br>;Primary end point(s): QIDS-16;Timepoint(s) of evaluation of this end point: Baseline and main endpoint = 1 week after the psilocybin dosing session
- Secondary Outcome Measures
Name Time Method