Psilocybin in Depression Resistant to Standard Treatments

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).

Intervention / Treatment

  • Psilocybin assisted therapy (COMBINATION_PRODUCT)
    A package of psychological therapy and a single dosing session of psilocybin.
  • Placebo assisted therapy (COMBINATION_PRODUCT)
    A package of psychological therapy and a single dosing session of placebo.

Condition or Disease

  • Treatment Resistant Depression

Phase

  • Phase 2
  • Study Design

    Study type: INTERVENTIONAL
    Status: Recruiting
    Study results: No Results Available
    Age: 25 Years to 80 Years
    Enrollment: 60 (ESTIMATED)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    QUADRUPLE:
    • Participant
    • Care Provider
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Sep 01, 2020 ACTUAL
    Primary Completion: Sep 01, 2023 ESTIMATED
    Completion Date: Nov 01, 2023 ESTIMATED
    Study First Posted: Jul 13, 2021 ACTUAL
    Last Updated: Jul 15, 2021

    Sponsors / Collaborators

    Lead Sponsor: King's College London
    Lead sponsor is responsible party
    Responsible Party: N/A

    Participant Groups

    • No description provided

    • No description provided

    Eligibility Criteria

    Sex: All
    Minimum Age: 25
    Maximum Age: 80
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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.

    This clinical trial is recruiting

    Are you interested in participating in this trial or others? We'd love to help.

    Primary Outcomes
    • Investigator rated depression scale

    Secondary Outcomes
    • Participant rated depression scale

    More Details

    NCT Number: NCT04959253
    Acronym: PsiDeR
    Other IDs: 252750
    Study URL: https://clinicaltrials.gov/study/NCT04959253
    Last updated: Sep 29, 2023