Agitation
Conditions
Keywords
Agitation, Schizophrenia, Randomized, Blind, Parallel, Intramuscular Haloperidol, Controlled, Multicenter, Clinical Trial, Efficacy, Safety, Intramuscular Levosulpiride, Chinese, PANSS-EC, ACES, CGI, BPRS, PANSS, RSESE, BAS
Brief summary
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.
Detailed 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) \[ Designated as safety issue: Yes \]
Interventions
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.
DRUGIntramuscular 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.
Sponsors
Shanghai Hotmed Sciences Co.,LTD
Shanghai Mental Health Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the change of PANSS-EC total scores | from baseline to the end of study(72 hours after first dosing) |
Secondary
| Measure | Time frame |
|---|---|
| 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 Agitation Calmness Evaluation Scale(ACES) | 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) |
| the change of every item of PANSS-EC | from baseline to the end of study (72 hours after first dosing) |
Countries
China
Outcome results
None listed