JPRN-UMIN000007942已完成未知
ong-term study on discontinuation rate, resolution/remission, and improvement in social functioning rate associated with atypical antipsychotic medications in patients with schizophrenia
JUMPs Research Group0 个研究点目标入组 300 人开始时间: 2012年5月14日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 ot applicable（—）
- 性别
- All
入选标准
- •The subjects will be patients meeting all of the following criteria.
- •- Out-patients 20 years of age or older at the time informed consent is obtained
- •- Patients with schizophrenia meeting the DSM-IV-TR diagnostic criteria
- •- Patients who require treatment with an antipsychotic medication, or patients who need to switch their current antipsychotic medication because the treatment is ineffective or poorly tolerated, or for some other reason
- •- Patients who personally give written informed consent to participate in the study
排除标准
- •Patients meeting any of the following criteria will be excluded from the study.
- •- Patients with a prior history of hypersensitivity to components of the study drugs or to risperidone
- •- Patients who are strongly under the influence of central nervous depressants such as barbiturate derivatives
- •- Patients on adrenalin treatment
- •- Patients on azole antimycotics (except for topicals) or HIV protease inhibitors
- •- Patients with moderate to severe renal impairment (creatinine clearance < 50 mL/min at eligibility screening)
- •- Patients with poorly controlled diabetes mellitus (HbA1c (NGSP level) >= 8.4% at eligibility screening)
- •- Patients with symptoms that remain severe despite adequate treatment, and patients for whom the use of clozapine is contraindicated
- •- Patients with other mental conditions
- •- Patients with Parkinson's disease
- •- Patients with malignant syndromes or similar symptoms, and patients with water intoxication
- •- Patients who are physically exhausted from dehydration, poor nutrition, or the like
- •- Patients with malignancies who require treatment
- •- Patients with a history of alcohol or drug abuse
- •- Women who are or may be pregnant, breastfeeding women, or women who want to become pregnant while participating in the study
- •- Patients who are highly likely to attempt suicide (patients with a CGI-SS (Clinical Global Impression Scale for Severity of Suicidality) >= 4)
- •- Patients who investigators judge to be unsuitable as subjects
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