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临床试验/CTRI/2023/05/052952
CTRI/2023/05/052952招募中Unknown

Efficacy of ketamine amongst patients with treatment resistant obsessive compulsive disorder: a double blind randomized placebo control trial

Institute of Psychiatry COE0 个研究点目标入组 0 人开始时间: 待定最近更新:

试验速览

阶段
Unknown
状态
招募中
发起方

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

入选标准

  • (1) Subjects were male or female (postmenopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control, including complete abstinence, during the testing period) between the age of 18 and 65 yrs.
  • (2) All subjects had a DSM V-TR diagnosis of Obsessive Compulsive Disorder by structured clinical interview (SCID), with a Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score >24 (26, 27).
  • (3) OCD was treatment-refractory, as defined by a Y-BOCS >24 despite two SSRI trials of adequate dose and duration and having been offered prior CBT treatment.
  • (4) Subjects were required to have had stable doses of all psychiatric medications for the month prior to treatment and have had no changes of dosage of SSRIs or clomipramine for at least 2 months prior to study enrollment. Most subjects received their treatment elsewhere; doses and duration of previous medication trials were verified through consultation with treating psychiatrists and review of past medical and pharmacy records.
  • 5) Subjects were medically and neurologically healthy on the basis of physical examination, medical laboratory assessment, EKG, and medical history. Individuals with stable medical conditions or taking medications without major CNS effects (e.g., oral hypoglycemics) were eligible if their medications had not been adjusted in the month prior to entry.
  • (6) Subjects could have no lifetime history of substance dependence diagnosis by SCID (excluding tobacco)

排除标准

  • 1)Subject with comorbid depression, psychosis and any organic cause resulting in psychiatric manifestation
  • 2)Current substance abuse or alcohol dependence in past month
  • 3)Mental retardation, pervasive developmental disorder,
  • 4)Epilepsy and other neurological disorder
  • 5)Any other co-morbid psychiatric illness
  • 6)Hypertension/ cardiac morbidity
  • 7)Raised intracranial tension
  • 8)Acute or chronic debilitating physical illness
  • 9)Pregnancy

研究者

发起方
Institute of Psychiatry COE

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