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临床试验/IRCT2013110415276N1
IRCT2013110415276N1已完成2 期

Evaluating Lamotrigine in relapse prevention following intravenous ketamine in 18-65 years old patients with treatment resistant depression in ziaeian hospital in 2013-2014 in a pilot study

Vice chancellor for research, Tehran University of Medical Sciences0 个研究点目标入组 30 人开始时间: 待定最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
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
Interventional

入排标准

年龄范围
18 years 至 65 years(—)
性别
All

入选标准

  • 1- patients 18 to 65 years 2- be able to understand the intervention 3- submit their written consent. 4- Being infected with treatment-resistant depression diagnosed by a psychiatrist. 5- current depressive episode lasting 4 to 6 weeks. 6- Be at least at the second stage of TRD (Failure to respond to antidepressant treatment with 2 drug families in the current episode based on Antidepressant Treatment History Form). 7- HDRS score of 21 with Hamilton scoring is higher or equal to 18. 8- Women of reproductive age have negative ßHCG and use reliable method of contraception during the study period.
  • Exclusion criteria: 1- patients with depression secondary to medical illness, drug or alcohol abuser (except nicotine and caffeine) according to the criteria of DSMIV.
  • 2- pregnant or lactating women. 3- patients with a history of seizure disorder other than epilepsy and fever. 4- patients with a known history of intolerance or sensitivity to ketamine and lamotrigine. 5- patients with diagnosis of schizophrenia and bipolar disorder, and psychotic signs. 6- patients with Tourette syndrome, autism and mental retardation. 7- patients at serious risk of suicide and homicide. 8- patients with obstructive sleep apnea or a history of difficult airway management in previous anesthesia. 9- patients treated with MAO irreversible inhibitors during the two weeks prior to the intervention. 10- patients with clinical and laboratory evidence of medical disorders, such as impaired hepatic or renal function, coronary disease, cerebrovascular disease, viral hepatitis B and C, acquired immunodeficiency syndrome, diabetes mellitus, uncontrolled hypertension, unmodified hypothyroidism or hyperthyroidism, neurological , immunological or hematologic disorders and in general, patients with clearly abnormal findings in laboratory tests, physical examination, or electrocardiogram.

排除标准

  • 未提供

研究者

发起方
Vice chancellor for research, Tehran University of Medical Sciences

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