EUCTR2019-003984-24-DE进行中（未招募）1 期
A phase II randomized, double-blind, active placebo-controlled parallel group trial to examine the efficacy and safety of psilocybin in treatment-resistantmajor depression - Efficacy and safety of psilocybin in treatment-resistant major depression
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 144
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) 25 to 65 years of age
- •2) Diagnosis of major depressive disorder (single and recurrent episodes) of moderate to
- •severe degree (HAM-D score = 17) according to the Diagnostic and Statistical Manual of
- •Mental Disorders (DSM-5) without psychotic features. Included ICD-10 diagnoses are
- •F32.1, F32.2, F33.1, F33.2.
- •a. If single episode, duration must be = 3 months.
- •3) Patients must meet criteria for treatment-resistance, defined as
- •a. no adequate improvement despite two adequate courses of antidepressant
- •treatment (6 weeks each, minimum) of different pharmacological classes in the
- •current depressive episode. Augmentation with an add-on treatment counts as a
- •second treatment.
- •4) Patients have discontinued any monoaminergic psychiatric medication (i.e. SRIs,
- •antipsychotic medication) for at least 2 weeks (fluoxetine: 5 weeks) before the first dosing
- •a. Patients who are still on any monoaminergic psychiatric medication at screening
- •must agree to down-titrate over an individualized down-titration schedule in close
- •supervision by their out-patient psychiatrist and the study team. The treating
- •psychiatrist must agree to supervise and monitor the down-titration and to
- •collaborate with the study team by signing a treatment agreement form”.
- •b. If the treating psychiatrist refuses to monitor the down-titration, the patient has to
- •agree to down-titrate under supervision of clinicians in the outpatient clinics of the
- •two study sites or trial physicians and to come in for weekly monitoring visits.
- •5) The subjects are abstinent from alcohol (breathalyzer blood alcohol concentration (BAC)
- •level 0.00) and have a negative urine drug screening at day of dosing.
- •6) The subject must be medically stable based on clinical laboratory tests, medical history,
- •vital signs, and 12-lead ECG performed at screening. If the results of the serum chemistry
- •panel, hematology, or urinalysis are outside the normal reference ranges, retesting of an
- •abnormal lab value(s) that may lead to exclusion will be allowed once during the screening
- •phase. In 12-lead ECG, QTcF should be = 450 ms for males or = 470 ms for females and
- •PR-interval < 220 ms at screening. A retest of an abnormal ECG value will be allowed once
- •Coordinating Investigator
- •Prof. Dr. med. Gerhard Gründer
- •Study Sites
- •Central Institute of Mental Health (CIMH) Mannheim
- •Charité Berlin, Campus Mitte
- •EPIsoDE_01 Study Protocol_V04_09/2021 Page 68 of 153
- •in the screening phase. Blood pressure will be the average of 2 measurements. The subject
- •may be included only if the investigator judges the abnormalities or deviations from normal
- •to be not clinically significant or to be appropriate and reasonable for the population under
- •study. This determination must be recorded in the subject's source documents and initialed
- •by the investigator.
- •7) The subject must be willing and able to adhere to the prohibitions and restrictions specified
- •in this protocol.
- •8) The subject must sign an informed consent form indicating that he/she understands the
- •purpose of and procedures required for the study including peripheral biomarker monitoring
- •(i.e., blood) and is willing to participate in the study.
- •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 144
- •F.1.3 Elderly (>=65 years) no
- 另有 1 项未显示
排除标准
- •1) Currently comorbid or previously diagnosed DSM-5 diagnosis of a
- •a. major depressive episode with psychotic features/major depressive disorder with psychotic features (ICD-10: F32.3)
- •b. schizophrenia spectrum and other psychotic disorders, including schizotypal (personality) disorders, delusional disorder, brief psychotic
- •disorder, schizophreniform disorder, schizoaffective disorder, substance/medication-induced psychotic disorder and psychotic disorder
- •due to another medical condition (ICD-10: F20 – F29)
- •c. bipolar and related disorders (ICD-10: F30/F31)
- •d. cluster A personality disorders (paranoid personality disorder, schizoid personality disorder, schizotypal personality disorder) and/or borderline personality disorder
- •i. Patients will be carefully screened for presence of those personality
- •disorders by using the SCID-5-PD.
- •e. Post-traumatic stress disorder (PTSD; ICD-10: F43.1)
- •2) A family history (first-degree relative) of psychosis and/or bipolar disorder
- •3) The subject has a current or recent history of clinically significant suicidal ideation within the past 6 months, corresponding to a score of 4
- •(active suicidal ideation with some intent to act, without specific plan) or 5 (active suicidal ideation with specific plan and intent) for ideation on
- •the C-SSRS, or a history of suicidal behavior within the past 1 year, as validated by the C-SSRS at screening. Subjects with a prior suicide attempt of any sort, or prior serious suicidal ideation/plan > 6 months ago, should be carefully screened for current suicidal ideation and only included at the discretion of the investigator.
- •4) Current comorbid psychiatric diagnosis except their major diagnosis (inclusion criterion 3) in form of
- •a. Diagnoses mentioned under exclusion criterion 1)
- •b. Substance use disorder (except tobacco-related disorders/caffeinerelated disorders)
- •i. Alcohol consumption must be limited to = 40 gram for men and = 20 gram for women per day, e.g. = two/one large beer (0.5 l) for men/women.
- •5) Use of classical psychedelics (i.e. LSD, psilocybin, mescaline, dimethyltryptamine) in the past year and or more than five life-time
- •uses of classical psychedelics.
- •6) Failure to establish sufficient rapport with the two therapists as judged by them after the first two preparation sessions
- •7) Lithium intake
- •8) The subject has undergone electroconvulsive therapy (ECT) within twelve months prior to screening or treatment with ketamine or esketamine within six months prior to screening.
- •9) The subject has received any prior treatment with vagal nerve stimulation, or a deep brain stimulation device.
研究者
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