The Safety and Efficacy of Psilocybin in Participants with Treatment Resistant Depression (P-TRD) - Psilocybin in Participants with Treatment Resistant Depression (P-TRD)

COMPASS Pathfinder, Limited0 个研究点目标入组 398 人开始时间: 2017年12月14日最近更新: 2021年10月8日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: COMPASS Pathfinder, Limited
入组人数: 398

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•Participants meeting all the following inclusion criteria at Screening (V1) should be considered for admission into the study:
•1. Signed Informed Consent Form (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 and 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 that country.
•6. McLean Screening Instrument for Borderline Personality Disorder <7 at Screening (V1).
•7. Not taking any antidepressants, mood stabilizers, or antipsychotics at the time of Screening Visit V1.
•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 358
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 40

排除标准

•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, depression with psychotic features, bipolar disorder, delusional disorder, paranoid personality disorder, schizoaffective disorder, borderline personality disorder, post traumatic stress disorder (PTSD) 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 psychotherapy that will not remain stable for the duration of the study. Psychotherapy cannot be initiated within 21 days of baseline.
•4. Current (within the last year) alcohol or substance use disorder 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) prior suicidal attempts, 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.
•8.Prior exposure to psilocybin and other psychedelics.
•General Medical Exclusion Criteria:
•9. Women who are pregnant, nursing, or planning a pregnancy. Participants who are sexually active must agree to use an acceptable 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).
•10. 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.
•11. Uncontrolled insulin-dependent diabetes.
•12. Seizure disorder.
•13. 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 MM.
•14. Current enrolment in any investigational drug or device study or participation in such within 30 days of Screening (V1).
•15. Current enrolment in an interventional study for depression 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.

研究者

发起方

COMPASS Pathfinder, Limited

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