Psilocybin in Depression Resistant to Standard Treatments

NCT04959253 | Unknown Phase 2 DMC

• 1 other identifier: 252750
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Treatment Resistant Depression

Outcome Measures

Primary Outcomes (1)

• Montgomery Asberg Depression Rating Scale

  Investigator rated depression scale

  3 weeks from baseline. Lower score is a better outcome.

Secondary Outcomes (1)

• Quick Inventory of Depressive Symptoms SR 16

  3 weeks from baseline. Lower score is a better outcome.

Study Arms (2)

Psilocybin 25mg PO

EXPERIMENTAL

Combination Product: Psilocybin assisted therapy

Placebo PO

PLACEBO COMPARATOR

Combination Product: Placebo assisted therapy

Interventions

Psilocybin assisted therapy COMBINATION_PRODUCT

A package of psychological therapy and a single dosing session of psilocybin.

Psilocybin 25mg PO

Placebo assisted therapy COMBINATION_PRODUCT

A package of psychological therapy and a single dosing session of placebo.

Placebo PO

Eligibility Criteria

• Age: 25 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• King's College London: lead
• South London and Maudsley NHS Foundation Trust: collaborator

Study Sites (1)

Clinical Research Facility, King's College Hospital

London, SE5 9RS, United Kingdom

RECRUITING

Related Publications (1)

• Rucker J, Jafari H, Mantingh T, Bird C, Modlin NL, Knight G, Reinholdt F, Day C, Carter B, Young A. Psilocybin-assisted therapy for the treatment of resistant major depressive disorder (PsiDeR): protocol for a randomised, placebo-controlled feasibility trial. BMJ Open. 2021 Dec 1;11(12):e056091. doi: 10.1136/bmjopen-2021-056091.

  PMID: 34853114 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• James Rucker, MD PhD

  King's College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

James Rucker

CONTACT

+442032991851; kingscrf@kcl.ac.uk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2021
• First Posted: July 13, 2021
• Study Start: September 1, 2020
• Primary Completion: September 1, 2023
• Study Completion: November 1, 2023
• Last Updated: July 22, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)