Major Depressive Disorder MedDRA version: 20.0 Level: PT Classification code 10057840 Term: Major depression System Organ Class: 10037175 - Psychiatric disorders MedDRA version: 20.0 Level: PT Classification code 10057840 Term: Major depression System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Product Name: Psilocybin
Product Code: NA
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: Psilocybin
CAS Number: 520-52-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentr
Sponsors
Imperial College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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? ;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
| Measure | Time frame |
|---|---|
| Secondary end point(s): fMRI measures Other clinical ratings include: o QIDS-16 (daily measure) [82] o BDI II (two-weekly measure) [13] o HAM-D [14] o MADRS [34] o Spielberger’s Trait Anxiety Inventory (STAI) - Trait [15] o Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) [16] o Snaith Hamilton Anhedonia Pleasure Scale (SHAPS) [17] o Life Orientation Test (LOT-R) [18] o Meaning in Life Questionnaire (MLQ) [19] o Brief Resilience Scale (BRS) [20] o Dysfunctional Attitudes Scale (DAS) [21] o 44-item Big Five Inventory [22] o Peters 21-item delusional inventory (PDI) [23] o EASE anomalous subjective experience [24] o Ruminative Responses Scale (RRS) [25] o White Bear Suppression Inventory (WBSI) [26] o Barrett Impulsivity Scale (BIS) [27] o Brief Experiential Avoidance Questionnaire [28] o Modified Tellegen Absoprtion Questionnaire (MODTAS) [29] o Scale To Assess the Therapeutic Relationship (STAR) [30] o Credibility/Expectancy Questionnaire [31] o Connectedness to Nature Scale (CNS) [32] o Political Perspective Questionnaire (PPQ) o Social Connectedness Scale (SCS) [33] o Bech-Rafaelsen Mania Rating Scale (MAS/MRS) [34] o Revised Santa Clara brief compassion scale (5 items) (SCBCS) [35] o Gratitude Questionnaire (GQ-6) [36] o Short Suggestibility Scale (SSS) [37] o Self-esteem: Rosenberg Self-Esteem Scale (4 items) (RSE) [38] o Universality subscale of the Spiritual Transcendence Scale (STS) [39] o Oxford Questionnaire on the Emotional Side-effects of Antidepressants (OQuESA) [40] o Lauks Emotional Intensity Scale (LEIS) [41] o The Suicidal Ideation Attributes Scale (SIDAS) [84] o Sexual dysfunction (PRSEXDQ-SALSEX) [83] o Barnes Akathisia Rating Scale (BARS) [85] o Work Productivity and Activity Impairment Questionnaire (WPAI) [87] o The Work and Social Adjustment Scale (WSAS) [88] o Self-constructed Connectedness Questionnaire o Standard Assessment of Personality – Abbreviated Scale (SAPAS) [96] o Positive and Negative Syndrome Scale (PANSS) [97] Measur | — |
Countries
United Kingdom
Contacts
Public ContactCarhart-Harris, Robin
Imperial College London
Outcome results
None listed