Improving Cognitive Function of Aripiprazole in Treating Adolescents and Young Adults With Psychotic Disorder
2007年10月9日 更新者:Genovate Biotechnology Co., Ltd.,
A Obervational, Prospective Study to Evaluate the Effectiveness of Improving Cognitive Function of Aripiprazole in Treating Adolescents and Young Adults With Psychotic Disorder in Taiwan
This is a 24-week, observational, prospective study to evaluate the effectiveness of improving cognitive function of aripiprazole in treating adolescents and young adults with psychotic disorder in Taiwan.
Approximately 120 qualified patients who have clinical diagnosis of DSM-IV of psychotic symptom (e.g.
schizophrenia or other psychotic disorders such as schizophreniform disorder, schizoaffective disorder, delusional disorder, shared psychotic disorder, bipolar disorder with psychotic feature or psychotic disorder not otherwise specified.)
will be recruited to achieve at least 100 evaluable subjects.
After signing the informed consent form, the demographics, medical history and concomitant medication will be recorded.
Besides, physical examination, vital sign, BMI, DSM-IV multiaxial examination, CGI-S and menstrual history will be conducted.
Laboratory tests and pregnancy test will be optionally conducted.
After evaluating all variables obtained, the eligible patients will be enrolled into study.
Patients who fulfill the inclusion / exclusion criteria will be performed the CPT, WCST, BPRS and WHOQOL.
Afterwards, patients will be given their first medication at this visit (5 mg ~ 30 mg daily by subject).
Besides, the switching period is maximum 8 weeks and is depended upon the clinical judgment of investigator.
Efficacy will be evaluated by the change from baseline in Continuous Performance Test (CPT), Wisconsin Card Sorting Test (WCST), Clinical Global Impression Scale (CGI), Brief Psychiatric Rating Scale (BPRS) and The World Health Organization Quality of Life questionnaire (WHOQOL).
Safety will be evaluated by the frequency of adverse events, abnormal laboratory results, physical examination, vital sign, BMI and menstrual history for female subgroup analysis.
研究概览
地位
未知
条件
研究类型
观察性的
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
12年 至 25年 (孩子、成人)
接受健康志愿者
不适用
有资格学习的性别
全部
描述
Inclusion Criteria:
- Male or female in age between 12 and 25 years old.
- Clinical diagnosis of DSM-IV of psychotic symptom (e.g. schizophrenia or other psychotic disorders such as schizophreniform disorder, schizoaffective disorder, delusional disorder, shared psychotic disorder, bipolar disorder with psychotic feature or psychotic disorder not otherwise specified.).
- CGI-S ≧ 3 at screening visit.
- Informed Consent was obtained from the subject (and legal guardian as if necessary).
Exclusion Criteria:
- Pregnant or breast feeding women or planning a pregnancy.
- Patient received electroconvulsive therapy within 4 weeks before the screening visit.
- Patient has a history of hypersensitivity or allergy to investigated drug.
- A known severe adverse event related to any antipsychotic medication (including but not limited to haloperidol, chlorpromazine, thioridazine, pimozide, risperidone, quetiapine, ziprasidone).
- Any clinical condition or significant concurrent disease judged by the investigator to complicate the evaluation of the study treatment.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Chen Chih-Ken, PhD、Chang Gung Memorial Hospital, Keelung, Taiwan
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2007年11月1日
研究完成 (预期的)
2008年10月1日
研究注册日期
首次提交
2007年10月8日
首先提交符合 QC 标准的
2007年10月9日
首次发布 (估计)
2007年10月10日
研究记录更新
最后更新发布 (估计)
2007年10月10日
上次提交的符合 QC 标准的更新
2007年10月9日
最后验证
2007年10月1日
更多信息
与本研究相关的术语
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