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临床试验/ACTRN12609000256279
ACTRN12609000256279已完成3 期

Randomized trial of citalopram plus vitamins B12, B6 and folate versus citalopram plus placebo for the treatment of depressive episodes amongst adults aged 50 years or over

niversity of Western Australia0 个研究点目标入组 155 人开始时间: 2009年5月13日最近更新:

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
155

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Treatment
盲法
Blinded (masking used)

入排标准

年龄范围
50 Years 至 o limit(—)
性别
All

入选标准

  • age 50 years or over, of either sex - meet Diagnostic and Statistical Manual of Mental Disorders (4th edition) criteria for the diagnosis of major depressive episode within the context of a depressive disorder - Montgomery-Asberg Depression Rating Scale (MADRS) score of 20 or more - fluent in written and spoken English.

排除标准

  • - evidence of concurrent alcohol or substance abuse or dependency (Alcohol Use Disorders Identification Test – AUDIT = 7),
  • - clinical evidence of Parkinson’s disease (including treatment),
  • - prior clinical history of strokes,
  • - evidence of clinically significant cognitive impairment (i.e., Mini-Mental State Examination – MMSE score < 24),
  • - evidence of medical morbidity (such as cancer) that may compromise 12-month survival or availability for study assessments,
  • - currently receiving antidepressant treatment (antidepressant medication or electroconvulsive therapy),
  • - use of B-vitamins daily for more than 3 months, or receive regular B12 injections
  • - prior allergic reaction to citalopram or escitalopram,
  • - use of a monoamine oxidase inhibitor during the preceding 2 weeks,
  • - no active general practitioner,
  • - suicide plans,
  • - no written informed consent.

研究者

发起方
niversity of Western Australia

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