Early versus late initiation of treatment with Risperdal Consta in subjects with schizophrenia after an acute episode - Risperdal long acting injections after acute psychosis

Janssen Cilag EMEA Medical Affairs0 个研究点目标入组 0 人开始时间: 2005年10月26日最近更新: 2019年11月25日

适应症

试验速览

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•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
•Diagnostic and Statistical Manual of Mental Diseases, Fourth Edition (DSM-IV) diagnosis of schizophrenia
•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

•DSM-IV axis I diagnosis other than schizophrenia
•subjects being treated for the acute episode more than 14 days prior to randomization
•subjects treated with 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

发起方

Janssen Cilag EMEA Medical Affairs