EUCTR2005-002304-41-SE进行中（未招募）不适用
Early versus late initiation of treatment with Risperdal Consta in subjects with schizophrenia or schizoaffective disorder after an acute episode - Risperdal long acting injections after acute psychosis
Janssen-Cilag EMEA Medical Affairs0 个研究点目标入组 220 人开始时间: 2005年7月29日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 220
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
- •male or female subject
- •subject with an acute episode (maximum time of pre-treatment for the episode: 14 days at randomization)
- •age >=18 and <=65 years of age
- •subjects currently not treated or treated with oral antipsychotics or short-acting injectable antipsychotics (zuclopenthixol acutard is allowed) at doses not exceeding the registered dose
- •female subjects must be surgically sterile, or practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization, abstinence) before entry and throughout the study; and have a negative urine pregnancy test at trial entry
- •subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
- •Subjects eligible for treatment with Risperdal Consta according to the registered indication in the country; diagnosis according to Diagnostic and Statistical Manual of Mental Diseases, Fourth Edition (DSM-IV).
- •PANSS >=80 at the baseline visit
- •CGI-S >=5 at the baseline visit
- •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
- •DSM-IV axis I diagnosis other than schizophrenia or schizoaffective disorder
- •subjects being treated for the acute episode more than 14 days prior to randomization
- •subjects treated with clozapine during the lats two months before randomization or a conventional depot antipsychotic in the last 4 weeks prior to randomization (zuclopenthixol acutard is accepted as acute treatment)
- •subjects who are known non-responders to risperidone proven by adequate drug plasma levels (non-responders due to non-compliance are not excluded)
- •evidence of alcohol or drug abuse or dependence (except for nicotine and caffeine dependence) according to DSM-IV criteria diagnosed in the last month prior to entry
- •pregnant or breast-feeding females
- •have received an experimental drug or used an experimental medical device within 30 days prior to trial entry
- •history of severe drug allergy, drug hypersensitivity or neuroleptic malignant syndrome
- •known clinically significant laboratory abnormalities
- •known clinically significant ECG abnormalities
- •significant physical illness that might interfere with the trial conduct
- •subject with mental retardation
- •known hypersensitivity to risperidone
- •subjects with phenylketonuria
- •subject with acute risk of suicide at study entry
- •employees of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator
研究者
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