EUCTR2008-002384-13-IT进行中（未招募）不适用
Efficacy and Tolerability of Flexible Doses of Paliperidone ER in Symptomatic Subjects with Schizophrenia with duration of illness < 10 years - ND
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •To be eligible to enroll in this trial, all subjects must meet all of the following criteria: Subject meets the DSM-IV criteria for schizophrenia; Male or female, between 18 and 45 years of age, inclusive; Subject must be experiencing psychotic symptoms, with a PANSS total score at screening of ≥70, ≤100; Symptomatic subject who needs to be switched from the current oral antipsychotic therapy due to insufficient efficacy on symptoms (e.g. negative, positive, general) or due to side effects; Subject is followed as outpatients; Subject is able to read, understand and sign the Institutional Review Board (IRB)-approved informed consent form; Female subjects must be postmenopausal for at least 1 year, surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy), abstinent (at the discretion of the investigator), or, if sexually active, be practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, double-barrier method, male partner sterilization before entry and throughout the study. Female subjects must also have a negative urine pregnancy test at screening; Subject must be willing and able to fill out self-administered questionnaires.
- •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
- •Subjects who meet one or more of the following criteria cannot be selected: -Acute psychotic relapse that requires hospitalization; -First antipsychotic treatment ever; -On clozapine or a long-acting injectable antipsychotic during the last 3 months; -Serious unstable medical condition, including known clinically relevant laboratory abnormalities; -History or current symptoms of tardive dyskinesia; -History of neuroleptic malignant syndrome; -Judged to be at high risk for adverse events, violence, or self-harm; -Pregnant or breast-feeding female; -Participation in an investigational drug trial in the 30 days prior to selection; -Inability to swallow the study medication whole with the aid of water (subjects may not chew, divide, dissolve, or crush the study medication, as this may affect the release profile); -Subjects with a narrowing or blockage of their gastro-intestinal tract; -Subjects with current or known history (over the past 6 months) of substance dependence according to DSM-IV Criteria; -Known hypersensitivity to paliperidone ER or risperidone -Employees of the investigator or study center, persons with direct involvement in the proposed study or other studies under the direction of that investigator or study center, or family members of the employees or the investigator
研究者
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