A Randomized Blind Parallel Intramuscular Haloperidol-Controlled Multicenter Clinical Trial to Evaluate the Efficacy and Safety of Intramuscular Levosulpiride in the Treatment of Chinese Patients With Agitation Of Schizophrenia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 5
- 主要终点
- the change of PANSS-EC total scores
研究概览
简要总结
The primary objective of this study is to evaluate the efficacy and safety of Intramuscular Levosulpiride in the treatment of Chinese patients with Agitation Of Schizophrenia compared with Intramuscular Haloperidol by evaluating the change of PANSS-EC total scores at end of study (72 hours after first dosing) from baseline.
详细描述
Secondary Outcome Measures:
To evaluate the change of Agitation Calmness Evaluation Scale(ACES), Clinical Global Impression(CGI, including CGI-S and CGI-I),PANSS total scores,Brief Psychiatric Rating Scale(BPRS) total scores and every item of PANSS-EC from baseline to the end of study (Time Frame: 72 hours) [ Designated as safety issue: No ]
To evaluate the change of patients' main complain, physical examination, lab and ECG tests, AE、Rating Scale for Extrapyramidal Side Effect(RSESE) and Barnes Akathisia Scale(BAS)from baseline to the end of study (Time Frame: 72 hours) [ Designated as safety issue: Yes ]
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
- Single (Participant)
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
- •Male or female Chinese inpatients(are required to stay at hospital during the study) aged 18-65 years
- •Patients meeting the DSM-IV criteria for schizophrenia or schizophreniform psychosis
- •Agitated with a minimum total score of ≧ 15 on the five items of the PANSS-EC and at least one individual item score of ≧ 5 or two item score of ≧ 4 using the 1-7 scoring system
- •Written informed consent provided by patients' legal representative
排除标准
- •Investigator and his/her relatives
- •Participation in another drug trial within 3 months prior enrolment into this study
- •Female patients during their pregnant and lactation period
- •Any currently severe unstable medical illness or disease would affect assessment for this study, including epilepsy, angle closure glaucoma, disease of liver, kidney, gastrointestinal tract, respiratory system, cardiovascular system(including Ischemic Heart Disease), endocrine system, nervous system, immune or hematological system etc.
- •A significantly clinical abnormal value in ECG or lab results,ALT and AST values in the liver function test exceeding two times of the upper limits of normal values, urea nitrogen value arising up to 1.2 times of the upper limits of normal values, creatinine or serum potassium exceeding normal values
- •With a family history of sudden death
- •Meet the DSM-IV criteria for substance abuse within 1 year prior enrolment
- •Regularly use antipsychotics(clozapine within 90 days), antidepressants, mood stabilizers, anti-epileptics or prolonged-action preparations within 2 weeks prior enrolment
- •Use of Electroconvulsive therapy within 30 days prior enrolment
- •Systematically use of sulpiride, levosulpiride or haloperidol therapy within 30 days prior enrolment
- •History of or current neuroleptic malignant syndrome, severe EPS, significant tardive dyskinesia
- •Severe suicide attempt
- •Known hypersensitivity to sulpiride, levosulpiride or haloperidol, or history of severe drug hypersensitivity or hypersensitivity to more than 2 drugs
- •Use of psychotropics(except permitted drugs) within 12 hours prior enrolment
- •Known lack of efficacy to levosulpiride or haloperidol by formal treatment before
- •Organic mental disorders, including Mental retardation
- •History of psychosurgery treatment
- •Patients can not comply with study protocol
研究组 & 干预措施
1
Intramuscular Levosulpiride
干预措施: Intramuscular Levosulpiride (Drug)
2
Intramuscular Haloperidol
干预措施: Intramuscular Haloperidol (Drug)
结局指标
主要结局
the change of PANSS-EC total scores
时间窗: from baseline to the end of study(72 hours after first dosing)
次要结局
- the change of Agitation Calmness Evaluation Scale(ACES)(from baseline to the end of study (72 hours after first dosing))
- The Change of Clinical Global Impression(CGI, including CGI-S and CGI-I)(from baseline to the end of study (72 hours after first dosing))
- the change of PANSS total scores(from baseline to the end of study (72 hours after first dosing))
- the change of Brief Psychiatric Rating Scale(BPRS) total scores(from baseline to the end of study (72 hours after first dosing))
- the change of every item of PANSS-EC(from baseline to the end of study (72 hours after first dosing))
- the change of Rating Scale for Extrapyramidal Side Effect(RSESE)(from baseline to the end of study (72 hours after first dosing))
- the change of Barnes Akathisia Scale(BAS)(from baseline to the end of study (72 hours after first dosing))