EUCTR2015-002020-37-IE进行中（未招募）1 期
Ketamine for relapse prevention in recurrent depressive disorder: a randomised,controlled pilot trial - KINDRED Trial
St Patrick's Mental Health Services0 个研究点目标入组 98 人开始时间: 2015年8月4日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 98
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
- •Patients =18 years with DSM-V criteria for recurrent depressive disorder (RDD), a 24-item Hamilton Rating Scale
- •for Depression (HRSD-24) score of =21, and voluntarily admitted to SPUH for treatment of the acute depressive
- •episode will be invited to participate. The DSM-V criteria for RDD are =2 previous depressive episodes with at
- •least 2-months (consecutive) subthreshold or no symptoms in between. (The inclusion criterion for this trial was amended on 15.9.16 and the enriched criterion of >3 episodes of depression has been removed). HRSD-24 will be repeated on a weekly basis for the duration of the
- •inpatient stay. Upon meeting response criteria, patients will be invited to take part in the randomised controlled
- •pilot trial. They will be assessed by physical examination, routine haematology and biochemistry investigations,
- •and an ECG to screen for any medical conditions that might affect ability to be treated with ketamine.
- •For the randomised pilot trial, RDD patients must have (i) received antidepressant treatment for the
- •acute depressive episode, whether pharmacological, psychotherapeutic or multidisciplinary, (ii) achieved at least
- •response criteria (i.e. =60% decrease from baseline HRSD-24 score and score =16), (iii) have a nominated adult
- •who can stay with them for 24-hours on out-patient treatment days, (iv) have a Mini-Mental State Examination
- •(MMSE) score of =24, and (v) be able to provide informed consent.
- •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 58
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •Current involuntary admission, any condition rendering patients medically unfit for ketamine or midazolam;
- •active suicidal intention; dementia; lifetime history of bipolar disorder, post-traumatic stress disorder, or Axis 1
- •diagnosis other than RDD; ECT for treatment of the index depressive episode; alcohol/substance abuse in
- •previous six-months; pregnancy or inability to confirm use of adequate contraception during the trial;
- •inability/refusal to consent.
研究者
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