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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

Tracking Information
First Submitted Date  ICMJE July 1, 2021
First Posted Date  ICMJE July 13, 2021
Last Update Posted Date July 22, 2021
Actual Study Start Date  ICMJE September 1, 2020
Estimated Primary Completion Date September 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 15, 2021)
Montgomery Asberg Depression Rating Scale [ Time Frame: 3 weeks from baseline. Lower score is a better outcome. ]
Investigator rated depression scale
Original Primary Outcome Measures  ICMJE
 (submitted: July 1, 2021)
Montgomery Asberg Depression Rating Scale [ Time Frame: 3 weeks from baseline ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 15, 2021)
Quick Inventory of Depressive Symptoms SR 16 [ Time Frame: 3 weeks from baseline. Lower score is a better outcome. ]
Participant rated depression scale
Original Secondary Outcome Measures  ICMJE
 (submitted: July 1, 2021)
Quick Inventory of Depressive Symptoms SR 16 [ Time Frame: 3 weeks from baseline ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Psilocybin in Depression Resistant to Standard Treatments
Official Title  ICMJE A Randomised, Placebo Controlled Trial of Psilocybin in Treatment Resistant Depression: A Feasibility Study
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Treatment Resistant Depression
Intervention  ICMJE
  • Combination Product: Psilocybin assisted therapy
    A package of psychological therapy and a single dosing session of psilocybin.
  • Combination Product: Placebo assisted therapy
    A package of psychological therapy and a single dosing session of placebo.
Study Arms  ICMJE
  • Experimental: Psilocybin 25mg PO
    Intervention: Combination Product: Psilocybin assisted therapy
  • Placebo Comparator: Placebo PO
    Intervention: Combination Product: Placebo assisted therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 1, 2021)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 1, 2023
Estimated Primary Completion Date September 1, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: James Rucker +442032991851 kingscrf@kcl.ac.uk
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04959253
Other Study ID Numbers  ICMJE 252750
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party King's College London
Study Sponsor  ICMJE King's College London
Collaborators  ICMJE South London and Maudsley NHS Foundation Trust
Investigators  ICMJE
Principal Investigator: James Rucker, MD PhD King's College London
PRS Account King's College London
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP