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

Phase 2

Completed

• Conditions: Agitation
• Interventions: Drug: Intramuscular Levosulpiride; Drug: Intramuscular Haloperidol

• Registration Number: NCT00866645
• Lead Sponsor: Shanghai Mental Health Center

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) \[ Designated as safety issue: Yes \]

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-03-19
• Study First Submitted QC: 2009-03-19
• Study First Posted: 2009-03-20
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-02
• Last Update Posted: 2010-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Intramuscular Levosulpiride	Intramuscular Levosulpiride
2	Intramuscular Haloperidol	Intramuscular Haloperidol

Primary Outcome Measures

Name	Time	Method
the change of PANSS-EC total scores	from baseline to the end of study(72 hours after first dosing)

Secondary Outcome Measures

Name	Time	Method
the change of Agitation Calmness Evaluation Scale(ACES)	from baseline to the end of study (72 hours after first dosing)
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 every item of PANSS-EC	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)

Trial Locations

Locations (5)

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, China

The First Affilliated Hospital Of Kunming Medical College; 🇨🇳 Kunming, Yunnan, China