treatment resistant depression MedDRA version: 21.1 Level: LLT Classification code 10025454 Term: Major depressive disorder, recurrent episode System Organ Class: 100000004873 MedDRA version: 21.1 Level: LLT Classification code 10025463 Term: Major depressive disorder, single episode System Organ Class: 100000004873
Conditions
Interventions
Product Name: Psilocybin 5 mg
Pharmaceutical Form: Capsule
INN or Proposed INN: PSILOCYBINE
CAS Number: 520-52-5
Other descriptive name: Psilocybin
Concentration unit: mg milligram(s)
Concentration ty
Sponsors
COMPASS Pathfinder, Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Signed ICF. 2.18 years of age or older, depending on country-specific limits, at Screening (V1). 3.At least moderate MDD (single or recurrent episode as informed by DSM 5; duration of = 3 months and = 2 years) based on medical records, clinical assessment and documented completion of the version 7.0.2 MINI. 4.Hamilton Depression Rating Scale (17 item) score =18 at Screening (V1) and Baseline (V2, Day-1). 5.Currently receiving treatment with a selective serotonin reuptake inhibitor (SSRI; fluoxetine, fluvoxamine, sertraline, paroxetine, citalopram or escitalopram) at, or above, a minimum locally approved therapeutic dose for at least 6 weeks before Screening (V1) and Baseline (V2, Day -1). Dose changes within the adequate range are acceptable. To be defined as an adequate study, adherence of at least 75% is needed based on participant estimate of percentage of doses that were taken. 6.Failure to respond to an adequate dose and duration of 2, 3, or 4 pharmacological treatments for the current episode as determined through the MGH-ATRQ and using the supplementary advice on additional antidepressants not included in MGH-ATRQ. Augmentation with an add on treatment counts as a second treatment, provided it is approved for the adjunctive treatment of MDD in that country. 7.McLean Screening Instrument for Borderline Personality Disorder =65 years) yes F.1.3.1 Number of subjects for this age range 2
Exclusion criteria
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, McLean Screening Instrument for Borderline Personality Disorder and a structured clinical interview (version 7.0.2 MINI). 2.Prior electroconvulsive therapy and/or ketamine for current episode. 3.Ongoing use of an antidepressant medication, including augmentation or combination therapies, other than a single SSRI at Screening (V1) and Baseline (V2, Day -1). 4.Current psychological therapies that will not remain stable within 21 days of the psilocybin session. Psychological therapies cannot be initiated within 21 days of baseline. 5.Current (within the last year) alcohol or substance use disorder as informed by DSM 5 (diagnosed by MINI 7.0.2) at Screening (V1). 6.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 participant interview. 7.Depression secondary to other severe medical conditions according to clinicians’ judgement. 8.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: 9.Women who are pregnant, nursing or planning a pregnancy. Male and female 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, Day -1). 10.Cardiovascular conditions: recent stroke (140/90 mmHg) or clinically significant arrhythmia within 1 year of signing the ICF. 11.Uncontrolled or insulin dependent diabetes. 12.Seizure disorder. 13.Positive urine drug screen for illicit drugs or drugs of abuse at Screening (V1) and Baseline (V2, Day -1). 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 (MM). 14.Current enrolment in any investigational drug or device study or participation in such within 30 days prior to Screening (V1). 15.Current enrolment in another clinical study of an investigational medical or participation in such within 30 days of Screening (V1). 16.Abnormal and clinically significant results on the physical examination, vital signs, ECG or laboratory tests at Screening (V1). 17.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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to explore the efficacy of 25 mg psilocybin as an adjunct therapy to antidepressants in improving depressive symptoms. ;Secondary Objective: The secondary objective is to evaluate the safety and tolerability of psilocybin in participants with TRD based on adverse events (AEs), changes in vital signs, electrocardiograms (ECGs), clinical laboratory tests and suicidal ideation/behavior (measured using the Columbia-Suicide Severity Rating Scale [C SSRS]) score.;Primary end point(s): The primary endpoint is the change in MADRS total score from Baseline (Day 1) to 3 weeks post psilocybin administration.;Timepoint(s) of evaluation of this end point: 3 Weeks post-psilocybin | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •The proportion of participants with a response (defined as a = 50% improvement in MADRS total score from Baseline) at Week 3 post psilocybin administration •The proportion of participants with remission (defined as a MADRS total score = 10) at Week 3 post psilocybin administration •Changes from Baseline in CGI-S score at Week 3 post psilocybin administration. •Incidence of AEs •Change from Baseline to Day 1 in ECGs, and incidence of clinically important changes •Change from Baseline to Day 1 and to Week 3 in clinical laboratory tests, and incidence of clinically important changes •Change from Baseline to Day 1 in vital signs •Incidence of changes from Baseline in the C-SSRS at each post Baseline visit ;Timepoint(s) of evaluation of this end point: See section 7.1.1 | — |
Countries
Ireland, United States
Contacts
Public ContactEkaterina Malievskaia
COMPASS Pathfinder, Ltd
Outcome results
None listed