Trial | NCT00866645  Report issue

Title

A Study To Evaluate The Efficacy And Safety Of Intramuscular Levosulpiride In Patients With Agitation Of Schizophrenia
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

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    240
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.
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 ]
Study Started
Feb 28
2009
Primary Completion
Jul 31
2010
Study Completion
Jul 31
2010
Last Update
Dec 03
2010
Estimate

Drug Intramuscular Haloperidol

1ml：5mg/ampoul the recommended dose is 10 mg per day administered. Doses of 10 mg may be administered 5mg bid with an interval longer than 4 hours for 3 days.

  • Other names: Intramuscular Haloperidol parenteral solution

Drug Intramuscular Levosulpiride

2ml：50mg/ampoul the recommended dose is 100 mg per day administered. Doses of 100 mg may be administered 50mg bid with an interval longer than 4 hours for 3 days.

  • Other names: Intramuscular Levosulpiride parenteral solution

1 Experimental

Intramuscular Levosulpiride

2 Active Comparator

Intramuscular Haloperidol

Criteria 

Inclusion Criteria:

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
ACES≤3
Written informed consent provided by patients' legal representative

Exclusion Criteria:

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
No Results Posted