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

Shanghai Mental Health Center

Status and phase

Completed

Phase 3

Phase 2

Conditions

Agitation

Treatments

Drug: Intramuscular Levosulpiride

Drug: Intramuscular Haloperidol

Study type

Interventional

Funder types

Other

Identifiers

NCT00866645

SMHC-100

2004L03556

Details and patient eligibility

About

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.

Full description

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 ]

Enrollment

240 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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