NCT01860781已完成4 期
The Effect of Paliperidone Palmitate in Schizophrenia: A Prospective Naturalistic Case Series Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- CGI-S,I: Clinical Global Impression-Severity, Improvement
研究概览
简要总结
The purpose of this study is the evaluation of effectiveness of paliperidone palmitate within three different group of schizophrenia patients.
详细描述
In this study, the investigators are going to examine the effectiveness of paliperidone palmitate after changing from other antipsychotics. This study design is a Prospective Naturalistic Case Series Study. The effectiveness of paliperidone would be compared within three different groups of schizophrenia. Investigators would also assess the safety during 24 weeks follow up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18 ~ 65
- •Patient with schizophrenia according to DSM-IV criteria
- •Patient have signed on the informed consent, and well understood the objective and procedure of this study.
- •PANSSS total score <120
- •each Score of disorganized thought, paranoia hallucinatory behavior, abnormal tbought contests < 16
- •three different groups ( other antipsychotics refractory schizophrenia patitents : CGI> 4 chronic akathisia : DIEPSS overall severity >1, at least 1 month lasting symptoms poor compliance schizophrenia : CRS <3)
- •Competent patient who is manage to answer the questionnaires.
- •In case of female at child-bearing age, consent to use appropriate contraceptive methods(oral pill, contraceptive injection, intrauterine device, double barrier method and contraceptive patch) during entire duration of this study.
排除标准
- •No history of antipsychotics prescription
- •History of NMS(Neuroleptic malignant syndrome)
- •Allergic reaction or hypersensitive reaction of risperidone or paliperidone ER
- •clozapine medication within 1 month before screening
- •SSRI, MAOI, TCA medication within 2 months
- •Lithium, valproic acid, carbamazepine, topiramate, lamotrigine medication starting within 2 months
- •patient who is supposed to be impossible to participate to this study due to clinical risk of suicide or aggressive behavior based on clinician's opinion
- •current or previous history of drug depedence according to DSM-IV
- •Pregnant or breast-feeding female patient
- •Significant biochemical or hematological abnormality or abnormal finding of urinalysis, based on clinician's opinion
- •history of cardiac disease, which is related to QT prolongation(sick sinus, complete AV block, CHF, ventricular tachycardia, hypokalemia or hypocalcemia)
- •History of participating to other investigational drug trial within 1month prior to screening
- •Investigator or employee at clinical trial center, personnel related to investigator or trial center on this or other study, or family of employee or investigator
研究组 & 干预措施
paliperidone palmitate
Experimental
paliperidone palmitate
干预措施: paliperidone palmitate (Drug)
结局指标
主要结局
CGI-S,I: Clinical Global Impression-Severity, Improvement
时间窗: 24 weeks
次要结局
- PANSS: Positive and Negative Syndrome Scale(24 weeks)
- CRS: Clinician Rating Scale(24 weeks)
- KDAI-10: Korean Drug Attitude Inventory-10(24 weeks)
- injection site pain -VAS: Visual Analog Scale(24 weeks)
- LUNSERS: Liverpool University Neuroleptic Side Effect Rating Scale(24 weeks)
- SWN: Subjective Well-being Under Neuroleptic Treatment(24 weeks)
- DIEPSS: Drug-Induced ExtraPyramidal Symptoms Sclae(24 weeks)
研究者
Yong Min Ahn
professor
Seoul National University Hospital
研究点 (1)
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