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

Phase 1

• Conditions: Treatment-Resistant Depression (P-TRD); MedDRA version: 21.1Level: LLTClassification code 10025454Term: Major depressive disorder, recurrent episodeSystem Organ Class: 100000004873; MedDRA version: 21.1Level: LLTClassification code 10025463Term: Major depressive disorder, single episodeSystem Organ Class: 100000004873; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2017-003288-36-PT
• Lead Sponsor: COMPASS Pathfinder Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-12-29
• Last Update Posted: 28 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 216

Inclusion Criteria

Participants meeting all the following inclusion criteria at Screening (V1) should be considered for admission into the study
1.Signed ICF.
2.18 years of age or older at Screening (V1).
3.At least moderate MDD (single or recurrent episode as informed 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 using the supplementary advice on additional antidepressants not included in MGH ATRQ (Appendix III). Augmentation with an add on treatment counts as a second treatment, provided it is approved for the adjunctive treatment of MDD in Portugal.
6.McLean Screening Instrument for Borderline Personality Disorder < 7 at Screening (V1).
7.Have successfully discontinued all antidepressant 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

Participants meeting any of the following exclusion criteria at Screening (V1) will not be enrolled in the study.
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, borderline personality disorder, or any serious psychiatric comorbidity as assessed by medical history and a structured clinical interview (version 7.0.2 MINI).
2.Prior electroconvulsive therapy and/or 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 (within the last year) alcohol or substance abuse as informed by DSM 5 at Screening (V1).
5.Significant suicide risk as defined by (1) suicidal ideation as endorsed on items 4 or 5 on the C-SSRS within the past year, at Screening or at Baseline, or; (2) suicidal behaviors within the past year, or; (3) clinical assessment of significant suicidal risk during subject interview.
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, including exposure to psilocybin within the past year and use of psychedelics, such as ayahuasca, during the current depressive episode.
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), hypertension (blood pressure > 140/90 mmHg) or clinically significant arrhythmia within 1 year of signing the ICF.
10.Insulin-dependent diabetes mellitus or uncontrolled diabetes mellitus (HbA1c>8%)
11.Seizure disorder.
12.Positive urine drug screen for illicit drugs or drugs of abuse at V1 and/or 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 MM.
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