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
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