JPRN-jRCTs031230351招募中Unknown
Examination of safety and efficacy of psilocybin treatment for treatment-resistant depression: a single-arm open-label trial
chida Hiroyuki0 个研究点目标入组 12 人开始时间: 2023年9月21日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 < 60age old（—）
- 性别
- All
入选标准
- •1. Those who meet the criteria for depression according to Structured Clinical Interview for DSM-5 Disorders SCID-5-RV (ResearchVersion) Japanese Version
- •2. Male and female outpatients between the ages of 20 and 60 at the time of registration.
- •3. Inadequate response to 2 or more antidepressants at approved doses for 6 weeks or more for the current depressive episode
- •4. A Montgomery-Asberg Depression Rating Scale (MADRS) total score of 20 or higher at the time of screening
- •5. Being capable of providing informed consent confirmed with scores above 70% in the following four items: understanding, appreciation, reasoning, and the ability to express a choice in the MacArthur Competence Assessment Tool (MacCAT)
- •6. Written consent being provided by study participant
排除标准
- •1. Having previously received psilocybin for the treatment of depression
- •2. Depression with psychotic features according to the diagnostic criteria of the DSM-5
- •3. Presence of other comorbidities according to the diagnostic criteria of the DSM-5
- •4. Presence of neurodevelopmental disorders according to the diagnostic criteria of the DSM-5
- •5. A history of schizophrenia spectrum and other psychotic disorders according to the diagnostic criteria of the DSM-5 in any of blood parents, children, and siblings
- •6. A history of self-harm or suicidal attempts
- •7. Taking a monoamine oxidase (MAO) inhibitor or uridine diphosphate glucuronosyltransferase enzyme modulator
- •8. Taking 5-hydroxytryptophan or St. John's wort
- •9. Being pregnant, breastfeeding, or hoping to become pregnant
- •10. A history of epilepsy or seizures
- •11. A history of cerebrovascular disease
- •12. High blood pressure (systolic pressure 160 mmHg or more, diastolic pressure 100 mmHg or more)
- •13. A history of ocular trauma
- •14. Receiving electroconvulsive therapy within 3
- •months prior to enrollment
- •15. Substance-related disorders (excluding nicotine and caffeine) within 6 months
- •16. Positive urine screening for dependent substances (except for those who are positive for drugs taken for treatment)
- •17. Having a metallic substance in the body or having a pacemaker
- •18. Size of the head, neck and body are not suitable for MRI scanners
- •19. Having tattoos that are larger than one point (including tattoos and art make-up)
- •20. A high degree of claustrophobia
- •21. Significant deformity of brain structure (including congenital and traumatic)
- •22. At the time of registration, any of the following abnormal laboratory values
- •eGFR < 60mL/min/1.73m2
- •AST > 60IU/L
- •ALT > 84IU/L (males), ALT > 46IU/L (females)
- •23. Participated in another clinical trial within 12
- •weeks prior to enrollment (limited to those with invasion/intervention)
- •24. Those deemed unsuitable as research subjects by the principal investigator, etc.
研究者
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