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Psilocybin in Depression Resistant to Standard Treatments (PsiDeR)

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ClinicalTrials.gov Identifier: NCT04959253
Recruitment Status : Recruiting
First Posted : July 13, 2021
Last Update Posted : July 22, 2021
Sponsor:
Collaborator:
South London and Maudsley NHS Foundation Trust
Information provided by (Responsible Party):
King's College London

Brief 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).

Condition or disease Intervention/treatment Phase
Treatment Resistant Depression Combination Product: Psilocybin assisted therapy Combination Product: Placebo assisted therapy Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised, Placebo Controlled Trial of Psilocybin in Treatment Resistant Depression: A Feasibility Study
Actual Study Start Date : September 1, 2020
Estimated Primary Completion Date : September 1, 2023
Estimated Study Completion Date : November 1, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Psilocybin 25mg PO Combination Product: Psilocybin assisted therapy
A package of psychological therapy and a single dosing session of psilocybin.

Placebo Comparator: Placebo PO Combination Product: Placebo assisted therapy
A package of psychological therapy and a single dosing session of placebo.




Primary Outcome Measures :
  1. Montgomery Asberg Depression Rating Scale [ Time Frame: 3 weeks from baseline. Lower score is a better outcome. ]
    Investigator rated depression scale


Secondary Outcome Measures :
  1. Quick Inventory of Depressive Symptoms SR 16 [ Time Frame: 3 weeks from baseline. Lower score is a better outcome. ]
    Participant rated depression scale



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  • 17-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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04959253


Contacts
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Contact: James Rucker +442032991851 kingscrf@kcl.ac.uk

Locations
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United Kingdom
Clinical Research Facility, King's College Hospital Recruiting
London, United Kingdom, SE5 9RS
Contact: James Rucker, MD    +442032991851    kingscrf@kcl.ac.uk   
Sponsors and Collaborators
King's College London
South London and Maudsley NHS Foundation Trust
Investigators
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Principal Investigator: James Rucker, MD PhD King's College London
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Responsible Party: King's College London
ClinicalTrials.gov Identifier: NCT04959253    
Other Study ID Numbers: 252750
First Posted: July 13, 2021    Key Record Dates
Last Update Posted: July 22, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Depressive Disorder, Treatment-Resistant
Behavioral Symptoms
Mood Disorders
Mental Disorders
Psilocybin
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs