EUCTR2018-002577-22-IE进行中（未招募）1 期
The safety and efficacy of psilocybin as an adjunctive therapy in participants with treatment-resistant depression - Psilocybin augmentation therapy for TRD
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 20
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
- •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 <7 at Screening (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:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 18
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2
排除标准
- •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 (<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 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.
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