EUCTR2017-000219-18-GB进行中（未招募）1 期
Psilocybin vs. escitalopram for major depressive disorder: comparative mechanisms - Psilodep-RCT
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 50
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
- •Key inclusion criteria:
- •1. Major depressive disorder (DSM-IV)
- •2. Depression of moderate to severe degree (17+ on the 21-item HAM-D).
- •2. No MRI contraindications
- •3. No SSRI contraindications
- •4. Has a GP or other mental healthcare professional who can confirm diagnosis
- •5. 18-80 years of age
- •6. Males and females
- •7. Sufficiently competent with English language
- •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 45
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •Key exclusion criteria:
- •1. Current or previously diagnosed psychotic disorder
- •2. Immediate family member with a diagnosed psychotic disorder
- •3. Medically significant condition rendering unsuitability for the study (e.g., diabetes, epilepsy, severe cardiovascular disease, hepatic or renal failure etc.)
- •4. History of suicide attempts requiring hospitalisation.
- •5. History of mania
- •6. Psychiatric condition judged to be incompatible with establishment of rapport with therapy team and/or safe exposure to psilocybin, e.g. borderline personality disorder
- •7. Blood or needle phobia
- •8. Positive pregnancy test at screening or during the study
- •9. Current drug or alcohol dependence
- •10. No email access
- •11. Use of contraindicated medication
- •12. Patients presenting with abnormal QT interval prolongation at screening or with a history of this (QTc at screening above 440ms for men and above 470ms for women)
研究者
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