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

Agitation Clinical Trial

Official title:

A Randomized Blind Parallel Intramuscular Haloperidol-Controlled Multicenter Clinical Trial to Evaluate the Efficacy and Safety of Intramuscular Levosulpiride in the Treatment of Chinese Patients With Agitation Of Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00866645
• Other study ID #: 2004L03556
• Secondary ID: SMHC-100
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: March 19, 2009
• Last updated: December 2, 2010
• Start date: February 2009
• Est. completion date: July 2010

Study information

• Verified date: December 2010
• Source: Shanghai Mental Health Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 ]

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Agitation
• Psychomotor Agitation
• Schizophrenia

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	Hebei Mental Health Center	Baoding	Hebei
China	The First Affilliated Hospital Of Kunming Medical College	Kunming	Yunnan
China	Nanjing Brain Hospital	Nanjing	Jiangsu
China	Shanghai Mental Health Center	Shanghai	Shanghai
China	Xi'an Mental Health Center	Xi'an	Shaanxi

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Mental Health Center	Shanghai Hotmed Sciences Co.,LTD

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the change of PANSS-EC total scores		from baseline to the end of study(72 hours after first dosing)	No
Secondary	the change of Agitation Calmness Evaluation Scale(ACES)		from baseline to the end of study (72 hours after first dosing)	No
Secondary	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)	No
Secondary	the change of PANSS total scores		from baseline to the end of study (72 hours after first dosing)	No
Secondary	the change of Brief Psychiatric Rating Scale(BPRS) total scores		from baseline to the end of study (72 hours after first dosing)	No
Secondary	the change of every item of PANSS-EC		from baseline to the end of study (72 hours after first dosing)	No
Secondary	the change of Rating Scale for Extrapyramidal Side Effect(RSESE)		from baseline to the end of study (72 hours after first dosing)	Yes
Secondary	the change of Barnes Akathisia Scale(BAS)		from baseline to the end of study (72 hours after first dosing)	Yes