跳至主要内容
临床试验/EUCTR2007-001541-18-LT
EUCTR2007-001541-18-LT进行中(未招募)不适用

Triiodothyronine as an adjunct in treatment of acute schizophrenia

Institute of Psychophysiology and Rehabilitation (IRP) of the Kaunas University of Medicine0 个研究点目标入组 60 人开始时间: 2007年3月16日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
60

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

  • 1.Age =18 years of old and < 50 years of old.
  • 2.Signed informed consent.
  • 3.DSM-IV diagnosis of schizophrenia 295.1 – 295.9, at least half a year.
  • 4.An acute psychotic episode at screening and at baseline (PANSS score 70-120, inclusive).
  • 5.Good physical health based on a physical examination, ECG results and laboratory tests results at screening.
  • 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
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • 1.Current DSM-IV axis I diagnosis other than schizophrenia.
  • 2.DSM-IV diagnosis of substance dependence within six month prior to screening.
  • 3.Any medical condition that potentially can alter absorption, metabolism or excretion of the medication (Crohn's disease, liver disease, renal disease).
  • 4.Injection of depot antipsychotics within 120 days before screening.
  • 5.History or presence of any significant or unstable cardiovascular, respiratory, neurological, seizures, cerebrovascular, renal, hepatic, endocrine or immunologic disease, unstable systemic diseases.
  • 6.Thyroid disorder or use of a thyroid medication.
  • 7.Significant risk of suicidal or violent behavior.
  • 8.Known allergic reactions to risperidone or T3, history of neuroleptic malignant syndrome and tardive dyskinesia.
  • 9.Use of MAO inhibitors within four weeks before screening
  • 10.ECT within three month before screening.
  • 11.Pregnancy or breastfeeding.

研究者

发起方
Institute of Psychophysiology and Rehabilitation (IRP) of the Kaunas University of Medicine

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