JPRN-jRCTs031210124招募中未知
Examination of efficacy and safety of ketamine treatment and exploration of the neural circuitry basis of its treatment effect on treatment-resistant depression: double-blind randomized placebo-controlled trial and extension open-label single-arm trial
chida Hiroyuki0 个研究点目标入组 34 人开始时间: 2021年5月31日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 34
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.Outpatients or inpatients who meet the criteria for depression according to Structured Clinical Interview for DSM-5 Disorders SCID-5-RV (Research Version) Japanese Version
- •2. Men and women 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 22 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 esketamine or ketamine for the treatment of depression
- •2. Depression with psychotic features according to the diagnostic criteria of the DSM-5
- •3. Being pregnant, breastfeeding, or hoping to become pregnant
- •4. A history of epilepsy or seizures
- •5. A history of cerebrovascular disease
- •6. A history of ketamine hypersensitivity
- •7. High blood pressure (systolic pressure 160 mmHg or more, diastolic pressure 100 mmHg or more)
- •8. A history of cerebral hypertension
- •9. A history of severe cardiac compensatory failure
- •10. A history of glaucoma or ocular trauma
- •11. Receiving electroconvulsive therapy within 3 months prior to enrollment
- •12. Substance-related disorders (excluding nicotine and caffeine) within 6 months
- •13. Positive urine screening for dependent substances (except for those who are positive for drugs taken for treatment)
- •14. having a metallic substance in the body or having a pacemaker
- •15. the size of the head, neck and body are not suitable for MRI scanners
- •16. Having tattoos that are larger than one point (including tattoos and art make-up)
- •17. A high degree of claustrophobia
- •18. Significant deformity of brain structure (including congenital and traumatic)
- •19. At the time of registration, any of the following abnormal laboratory values
- •Serum creatinine 1.5 mg/dl or more
- •AST 150 IU/L or more
- •ALT 150 IU/L or more
- •20. Participated in another clinical trial within 12 weeks prior to enrollment (limited to those with invasion/intervention)
- •21. Those deemed unsuitable as research subjects by the principal investigator, etc.
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