Status:
COMPLETED
A Study To Evaluate The Efficacy And Safety Of Intramuscular Levosulpiride In Patients With Agitation Of Schizophrenia
Lead Sponsor:
Shanghai Mental Health Center
Collaborating Sponsors:
Shanghai Hotmed Sciences Co.,LTD
Conditions:
Agitation
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
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 Intramuscul...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2010
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT00866645
Start Date
February 1 2009
End Date
July 1 2010
Last Update
December 3 2010
Active Locations (5)
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1
Hebei Mental Health Center
Baoding, Hebei, China, 071000
2
Nanjing Brain Hospital
Nanjing, Jiangsu, China, 210029
3
Xi'an Mental Health Center
Xi'an, Shaanxi, China, 710061
4
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, China, 200030