NCT02453893Unknown3 期
Double-blind,Double-simulation,Risperidone-controlled,Multicentre Clinical Trial of Iloperidone in Patients With Schizophrenia
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.1 个研究点 分布在 1 个国家目标入组 288 人开始时间: 2013年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 288
- 试验地点
- 1
- 主要终点
- the score of Positive and Negative syndrome scale to evaluation the severity of schizophrenia
研究概览
简要总结
This research is a Randomized, double-blind, risperidone-controlled, multicenter clinical study. Chinese subjects with Ischemic Schizophrenia.
详细描述
Subjects will randomly enter into one of two groups,the period of treatment is 8 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •men and women aged 18 to 65 years with schizophrenia;
- •PANSS total score of at least 70 at screening and baseline;
- •at least 2 more than 4 points in 7 of PANSS-P;
- •informed consent.
排除标准
- •allergy with iloperidone or risperidone;
- •psychotic symptoms failing to improve after sufficient exposure to 2 antipsychotic treatment;
- •any other primary Axis 1 psychiatric diagnosis;
- •a history of alcohol or drug dependence in recent 1 year;
- •at imminent risk of harm to self or others;
- •systolic blood pressure≤90mmHg。
研究组 & 干预措施
oral iloperidone
Experimental
2~12mg/day for 2 weeks,12~24mg/day for 6 weeks.
干预措施: Iloperidone (Drug)
oral risperidone
Active Comparator
1~3mg/day for 2 weeks,3~6mg/day for 6 weeks.
干预措施: Risperidone (Drug)
结局指标
主要结局
the score of Positive and Negative syndrome scale to evaluation the severity of schizophrenia
时间窗: 8 weeks
次要结局
- the score of clinical global impressions to evaluation the severity of illness(8 weeks)
- the score of clinical global impressions to evaluation the improvement of illness(8 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
终止
不适用
Study Evaluating MyoRegulator® Treatment in Post-Stroke Upper Limb SpasticityMuscle SpasticityStrokeNCT04742257PathMaker Neurosystems Inc.28
Unknown
4 期
Clinical Study on Wuling Powder in Treating Metabolic Syndrome of Spleen Deficiency and DampnessMetabolic SyndromeNCT04812236Jiangsu Famous Medical Technology Co., Ltd.320
已完成
不适用
Multicenter Trial Investigating Performance and Safety of the Medical Device SiPore21®Overweight or ObesityNCT06087822Sigrid Therapeutics AB318
终止
1 期
Safety Study of AMG 811 in Subjects With Discoid Lupus ErythematosusCutaneous LupusDiscoid LupusLupusSystemic Lupus ErythematosusNCT01164917Amgen16
终止
2 期
A Multicenter Trial to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of HZN-825 in Patients With Diffuse Cutaneous Systemic SclerosisSclerosis, SystemicDiffuse Cutaneous Systemic SclerosisNCT04781543Amgen301