Psilocybin in Depression Resistant to Standard Treatments

  • STATUS
    Recruiting
  • days left to enroll
    31
  • participants needed
    60
  • sponsor
    King's College London
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Updated on 30 July 2021
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Summary

A single centre clinical trial to evaluate the feasibility, safety and efficacy of psilocybin, given under supportive conditions, in a randomised, blinded design in adult participants with treatment resistant major depressive disorder. The primary objective is to evaluate feasibility by measuring recruitment rates, dropout rates and by estimating the variance of the primary outcome measure (MADRS).

Details
Condition Treatment Resistant Depression
Treatment Psilocybin assisted therapy, Placebo assisted therapy
Clinical Study IdentifierNCT04959253
SponsorKing's College London
Last Modified on30 July 2021

Eligibility

 Yes No Not Sure

Inclusion Criteria

Age 25 - 80 years
Fluent in the English language
Fulfil Diagnostic and Statistical Manual of Mental Disorders (5th Edition) (DSM-5) criteria for a primary diagnosis of current single or recurrent episodes of MDD of at least moderate severity but without psychotic features as defined on the MINI 7.0. Positive and primary diagnoses on the MINI 7.0 will be subject to confirmation at clinical interview by a psychiatrist
-item HAM-D score 14
Have failed to respond to 2 or more antidepressants prescribed at the minimum effective dose for at least 6 weeks OR at least 1 antidepressant prescribed at the minimum effective dose for at least 6 weeks AND a course of evidence-based psychotherapy given for at least 6 sessions
For those aged 60 years, the first episode of depression must have started prior to their 60th birthday

Exclusion Criteria

Diagnosis of bipolar disorder (defined as meeting DSM-5 criteria for bipolar 1 or bipolar 2) on the MINI 7.0. Positive diagnoses on the MINI will be subject to confirmation at clinical interview by a psychiatrist
Diagnosis of psychotic disorder (defined as meeting DSM-5 criteria for any psychotic disorder) on the MINI 7.0, EXCEPT substance/medication induced psychotic disorder where the duration was limited to the acute period of direct intoxication with the substance/medication. Positive diagnoses on the MINI will be subject to confirmation at clinical interview by a psychiatrist
Diagnosis of drug or alcohol dependence syndrome (defined as meeting DSM-5 criteria for any dependence syndrome) on the MINI 7.0. Positive diagnoses on the MINI will be subject to confirmation at clinical interview by a psychiatrist
Diagnosis of any personality disorder (defined as meeting DSM-5 criteria for any personality disorder) based on clinical interview and the MINI 7.0. Positive diagnoses on the MINI will be subject to confirmation at clinical interview by a psychiatrist
Diagnosis of any dementia (defined as meeting DSM-5 criteria for any dementia disorder) based on clinical interview by a psychiatrist
Personal history of a 1 suicide attempt in the past year requiring hospitalization, defined using the CSSRS (Q6 (past year) = "y") and clinical interview with a psychiatrist
Other personal circumstances and behaviour judged to be incompatible with establishment of rapport or safe exposure to psilocybin
Depression secondary to other medical conditions
Medical diagnosis incompatible with psilocybin treatment
Inability to provide a screening blood sample, urine sample or electrocardiogram
Biochemical abnormalities (defined as falling outside the normal reference range) as evaluated by a full blood count, full biochemistry profile and thyroid function tests. Biochemical abnormalities must also be determined as clinically significant by a medical doctor to fulfil the criterion for exclusion
Electrocardiographic abnormalities, defined as any abnormality that is not normal sinus rhythm and determined as clinically significant by a medical doctor
Women of child bearing potential not using adequate contraception
Pregnant or breast-feeding women
Those unable to give informed consent
Non-registration with a GP or failure to consent to sharing of the GP summary care record and any psychiatric assessments held
Those enrolled in another drug trial
Hypersensitivity to the IMP or to any of the excipients or placebo
Exclusions for Pre-Existing Medical Conditions
Participants will be excluded if they have a current diagnosis of 1 of
Uncontrolled diabetes
Hypertension (defined as a systolic blood pressure 160mm/Hg or a diastolic blood pressure 100mm/Hg on three separate readings). All readings of systolic blood pressure 140mm/Hg or diastolic blood pressure 90mm/Hg will be reviewed by a clinician. Hypertension ascertained prior to dosing will be subject to clinical confirmation via collateral information from the GP or other source
Cardiac failure, defined as class IV of the New York Heart Association classification
Renal failure, defined as stage 4 (GFR 29mL/min)
Liver failure, defined as a clinical diagnosis of liver fibrosis, cirrhosis of the liver, liver failure or advanced liver disease
Any cardiac arrhythmia, except atrial fibrillation
Any form of epilepsy
Past diagnosis of 1 of
Cerebrovascular accident or intracerebral trauma
Myocardial infarction within 1 year prior to the screening visit
Clear my responses
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