NL-OMON33643撤回不适用
A randomized, parallel, double-blind, placebo controlled trial to investigate HPA-axis activation before and after electro-convulsive therapy in patients with a major depressive episode using an orally administered 5-HTP challenge test - 5-HTP challenge in patients with a major depressive episode.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Male or female sex
- •Age of 18-75 years (extremes included);
- •Diagnosed with a major depressive episode according to DSM-IV by attending psychiatrist;
- •Scheduled for an ECT course;
- •Signed Informed Consent;
排除标准
- •Severe hallucinations, delusions,or disorganized behaviour that could interfere with study compliance and/or provision of informed consent as to judgment of the psychiatrist;
- •Suicidal intent or behaviour that may render participation dangerous to the patient and/or to the staff as to judgment of the psychiatrist;
- •Severe cognitive impairment could interfere with study compliance and/or provision informed consent as to judgment of the psychiatrist or a MMSE score < 19;
- •Use of prescribed drugs with a known effect on the serotonergic system. A minimum of 7 days medication-free days prior to the first challenge will be maintained except for drugs requiring a longer washout period due to kinetic properties. Specifically the use of serotonergic antidepressant drugs (SSRI*s, SNRI*s, TCA*s, MAOI*s, Lithium and atypical antipsychotic) are prohibited for the mentioned periods;
- •Use of prescribed drugs with a known effect on the HPA-axis within 2 weeks of the first challenge. Specifically current oral corticosteroid use is prohibited.
- •Comorbid post-traumatic stress disorder (PTSD);
- •Clinically significant neuroendocrine disorders, specifically previous or current diagnosis of Cushing*s disease, Addison*s disease or adrenalectomy;
- •Any other clinically significant concomitant disease which may negatively influence the study objectives or affect the patients* compliance to study procedures;
- •Known history of adverse reactions to 5-HTP, carbidopa or granisetron.
- •Use of illicit drugs within two weeks prior to the first challenge;
- •Pregnant or breast feeding female patients;
- •Previous use of MDMA or ecstacy;
- •Blood donation according to the limits of the blood donation service prior to the first challenge.
- •Participation in an investigational drug study within 90 days prior to the first challenge, or participation in four studies (or more) in the year prior to the first challenge.
研究者
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