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临床试验/NL-OMON49004
NL-OMON49004招募中不适用

Pharmacogenetics to improve personalized antidepressant dosing in patients with severe depression; a randomized controlled trial using Tricyclic Antidepressants - Dosing of Tricyclic Antidepressants using Pharmacogenetics.

Radboud Universitair Medisch Centrum0 个研究点目标入组 250 人开始时间: 待定最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
250

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
18 至 99(—)

入选标准

  • Patients are in- and outpatients, having a primary diagnosis of severe major
  • depressive disorder (SCID-I diagnosis in agreement with DSM-5 criteria and a
  • Hamilton Rating Scale for Depression score * 19 (HRSD-17-item version), aged
  • 18-65 years, who, according to their physician, are eligible for treatment with
  • a TCA (Nortriptyline (NOR), Clomipramine (CLOMI) or Imipramine (IMI)). The
  • choice of the specific TCA is at the discretion of the physician in attendance.

排除标准

  • (1) Psychotic depression (2) Bipolar I or II disorder. (3) Schizophrenia or
  • other primary psychotic disorder.(4) Drug or alcohol dependence in the past 3
  • months. (5) Mental Retardation (IQ < 80). (6) For women: pregnancy or
  • possibility for pregnancy without adequate contraceptive measures. (7)
  • Breast-feeding. (8) Serious medical illness affecting the CNS, including but
  • not restricted to M Parkinson, SLE, brain tumour, CVA. (9) Relevant medical
  • illness as contra-indication for TCA use, such as recent myocardial infarction.
  • (10) Other drugs influencing the pharmacokinetics of the TCAs as based on a
  • list of interacting drugs. In case of psychotropic co-medication only a
  • benzodiazepine in a dose equivalent up to 4 mg lorazepam will be allowed.

研究者

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