EUCTR2009-017024-82-ES进行中（未招募）不适用
Clinical and neuropsychological factors associated with second generation antipsychotic response in patients diagnosed with first episode of early onset schizophrenia spectrum disorders
FUNDACIÓN SANT JOAN DE DE0 个研究点目标入组 0 人开始时间: 2009年11月17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
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. Patients of both sexes, aged 8 to 19 years, both inclusive.
- •2. Score of at least moderate severity on one of the positive psychotic symptom ratings of the PANSS or BPRS-C.
- •3. Meet DSM-IV criteria for first episode of schizophrenia, schizophreniform, schizoaffective disorder.
- •4. Patients with reproductive potential will use an effective birth control method during the entire duration of the trial. Women of reproductive age will be included after a negative pregnancy test result.
- •5. Informed consent of parents or legal guardian and informed assent of a mature minor.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 70
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. History of appropriate treatment with paliperidone, aripiprazole or haloperidol (defined as at least 8 weeks of treatment with doses of paliperidone 12 mg/d, aripiprazole 30 mg/d, haloperidol 8 mg/d during the final 2 weeks of treatment) during current psychotic episode.
- •2. History of appropriate antipsychotic treatment (8-16 weeks) with the study drugs during a previous episode.
- •3. Hypersensitivity to paliperidone, aripiprazole or haloperidol or presence of any contraindications to start any of these treatments depending on technical data sheet.
- •4. Bipolar disorder, primary posttraumatic stress disorder, primary personality disorder, diagnosed by a doctor and confirmed by KID-SCID
- •5. Current major depressive disorder that is clearly defined and therefore excludes diagnosis of EOSS.
- •6. Premorbid diagnosis of mental retardation
- •7. Endocrinological or neurological conditions that confound the diagnosis or are a contraindication to treatment (concurrent organic disease that is clearly defined and therefore excludes diagnosis of EOSS).
- •8. Pregnant or breastfeeding
研究者
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