A Study To Evaluate The Efficacy And Safety Of Intramuscular Levosulpiride In Patients With Agitation Of Schizophrenia
NCT ID: NCT00866645
Last Updated: 2010-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
240 participants
INTERVENTIONAL
2009-02-28
2010-07-31
Brief Summary
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Detailed Description
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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) \[ Designated as safety issue: Yes \]
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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1
Intramuscular Levosulpiride
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.
2
Intramuscular Haloperidol
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.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Shanghai Hotmed Sciences Co.,LTD
UNKNOWN
Shanghai Mental Health Center
OTHER
Responsible Party
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Shanghai Mental Health Center
Principal Investigators
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Huafang LI, MD,PhD
Role: STUDY_DIRECTOR
Drug Clinical Trial Office, Shanghai Mental Health Center
Locations
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Hebei Mental Health Center
Baoding, Hebei, China
Nanjing Brain Hospital
Nanjing, Jiangsu, China
Xi'an Mental Health Center
Xi'an, Shaanxi, China
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, China
The First Affilliated Hospital Of Kunming Medical College
Kunming, Yunnan, China
Countries
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Other Identifiers
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SMHC-100
Identifier Type: -
Identifier Source: secondary_id
2004L03556
Identifier Type: -
Identifier Source: org_study_id