The Safety and Efficacy of Psilocybin in Participants with Treatment Resistant Depressio

Phase 1

• Conditions: Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]; Treatment-Resistant Depression (P-TRD); MedDRA version: 20.0Level: LLTClassification code 10025454Term: Major depressive disorder, recurrent episodeSystem Organ Class: 100000004873; MedDRA version: 20.0Level: LLTClassification code 10025463Term: Major depressive disorder, single episodeSystem Organ Class: 100000004873

• Registration Number: EUCTR2017-003288-36-ES
• Lead Sponsor: COMPASS Pathways, Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-07-17
• Study Completion: 2021-09-27
• Last Update Posted: 26 September 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 233

Inclusion Criteria

1.Signed ICF.
2.18 years of age or older at Screening (V1).
3.At least moderate MDD (single or recurrent episode as defined by DSM 5; if single episode, duration of = 3 months and = 2 years) based on medical records, clinical assessment and documented completion of the version 7.0.2 MINI.
4.HAM D 17 (17 item) score = 18 at Screening (V1) and at Baseline (V2).
5.Failure to respond to an adequate dose and duration of 2, 3, or 4 pharmacological treatment for the current episode as determined through the MGH ATRQ. Failure includes inadequate response to an adequate duration and dose or failure to reach an adequate dose and duration due to lack of tolerance. Augmentation with an add on treatment counts as a second treatment.
6.McLean Screening Instrument for Borderline Personality Disorder < 7 at Screening (V1).
7.Have successfully discontinued all serotonergic medications at least 2 weeks prior to Baseline (V2).
8.Ability to complete all protocol required assessment tools without any assistance or alteration to the copyrighted assessments, and to comply with all study visits.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 195
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 21

Exclusion Criteria

Psychiatric Exclusion Criteria:
1.Current or past history of schizophrenia, psychotic disorder (unless substance induced or due to a medical condition), bipolar disorder, delusional disorder, paranoid personality disorder, schizoaffective disorder, or borderline personality disorder, as assessed by medical history and a structured clinical interview (version 7.0.2 MINI).
2.Prior electroconvulsive therapy and/or intravenous ketamine for current episode.
3.Current cognitive behavioural therapy (CBT) that will not remain stable for the duration of the study. CBT cannot be initiated within 21 days of baseline.
4.Current (< 1 year) alcohol or drug abuse as defined by DSM 5 at Screening (V1).
5.Significant risk of suicide based on the SSTS prior to randomisation defined as (a) a score of 3” or 4” on Questions 2 or 13; or (b) a score of 2” or higher on Questions 1a, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, or 14 over the past 13 months. Or, if active suicidal activity or ideation during the current episode, eligibility will be determined at the investigator’s discretion in conjunction with the medical monitor.
6.Depression secondary to other severe medical conditions.
7.Other personal circumstances and behaviour judged to be incompatible with establishment of rapport or safe exposure to psilocybin.
General Medical Exclusion Criteria:
8.Women who are pregnant, nursing, or planning a pregnancy. Participants who are sexually active must agree to use a highly effective contraceptive method throughout their participation in the study. Women of child bearing potential must have a negative urine pregnancy test at Screening (V1) and Baseline (V2).
9.Cardiovascular conditions: recent stroke (< 1 year from signing of ICF), recent myocardial infarction (< 1 year from signing of ICF), uncontrolled hypertension (blood pressure > 140/90 mmHg) or clinically significant arrhythmia within 1 year of signing the ICF.
10.Uncontrolled OR insulin dependent diabetes.
11.Seizure disorder.
12.Positive urine drug screen for illicit drugs or drugs of abuse at V1 and V2. Any positive urine drug test will be reviewed with participants to determine the pattern of use and eligibility will be determined at the investigator’s discretion in conjunction with the medical monitor.
13.Current enrolment in any investigational drug or device study or participation in such within 30 days of Screening (V1).
14.Current enrolment in an interventional study for depression or participation in such within 30 days of Screening (V1).
15.Abnormal and clinically significant results on the physical examination, vital signs, ECG, or laboratory tests at Screening (V1).
16.Any other clinically significant cardiovascular, pulmonary, gastrointestinal, hepatic, renal or any other major concurrent illness that, in the opinion of the investigator, may interfere with the interpretation of the study results or constitute a health risk for the participant if he/she takes part in the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified