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

Primary Purpose

Agitation

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Intramuscular Haloperidol
Intramuscular Levosulpiride
Sponsored by
Shanghai Mental Health Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Agitation focused on measuring Agitation, Schizophrenia, Randomized, Blind, Parallel, Intramuscular Haloperidol, Controlled, Multicenter, Clinical Trial, Efficacy, Safety, Intramuscular Levosulpiride, Chinese, PANSS-EC, ACES, CGI, BPRS, PANSS, RSESE, BAS

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hebei Mental Health Center
  • Nanjing Brain Hospital
  • Xi'an Mental Health Center
  • Shanghai Mental Health Center
  • The First Affilliated Hospital Of Kunming Medical College

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Intramuscular Levosulpiride

Intramuscular Haloperidol

Outcomes

Primary Outcome Measures

the change of PANSS-EC total scores

Secondary Outcome Measures

the change of Agitation Calmness Evaluation Scale(ACES)
The Change of Clinical Global Impression(CGI, including CGI-S and CGI-I)
the change of PANSS total scores
the change of Brief Psychiatric Rating Scale(BPRS) total scores
the change of every item of PANSS-EC
the change of Rating Scale for Extrapyramidal Side Effect(RSESE)
the change of Barnes Akathisia Scale(BAS)

Full Information

First Posted
March 19, 2009
Last Updated
December 2, 2010
Sponsor
Shanghai Mental Health Center
Collaborators
Shanghai Hotmed Sciences Co.,LTD
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1. Study Identification

Unique Protocol Identification Number
NCT00866645
Brief Title
A Study To Evaluate The Efficacy And Safety Of Intramuscular Levosulpiride In Patients With Agitation Of Schizophrenia
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Shanghai Mental Health Center
Collaborators
Shanghai Hotmed Sciences Co.,LTD

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 ]

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Agitation
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Intramuscular Levosulpiride
Arm Title
2
Arm Type
Active Comparator
Arm Description
Intramuscular Haloperidol
Intervention Type
Drug
Intervention Name(s)
Intramuscular Haloperidol
Other Intervention Name(s)
Intramuscular Haloperidol parenteral solution
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Intramuscular Levosulpiride
Other Intervention Name(s)
Intramuscular Levosulpiride parenteral solution
Intervention Description
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.
Primary Outcome Measure Information:
Title
the change of PANSS-EC total scores
Time Frame
from baseline to the end of study(72 hours after first dosing)
Secondary Outcome Measure Information:
Title
the change of Agitation Calmness Evaluation Scale(ACES)
Time Frame
from baseline to the end of study (72 hours after first dosing)
Title
The Change of Clinical Global Impression(CGI, including CGI-S and CGI-I)
Time Frame
from baseline to the end of study (72 hours after first dosing)
Title
the change of PANSS total scores
Time Frame
from baseline to the end of study (72 hours after first dosing)
Title
the change of Brief Psychiatric Rating Scale(BPRS) total scores
Time Frame
from baseline to the end of study (72 hours after first dosing)
Title
the change of every item of PANSS-EC
Time Frame
from baseline to the end of study (72 hours after first dosing)
Title
the change of Rating Scale for Extrapyramidal Side Effect(RSESE)
Time Frame
from baseline to the end of study (72 hours after first dosing)
Title
the change of Barnes Akathisia Scale(BAS)
Time Frame
from baseline to the end of study (72 hours after first dosing)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huafang LI, MD,PhD
Organizational Affiliation
Drug Clinical Trial Office, Shanghai Mental Health Center
Official's Role
Study Director
Facility Information:
Facility Name
Hebei Mental Health Center
City
Baoding
State/Province
Hebei
ZIP/Postal Code
071000
Country
China
Facility Name
Nanjing Brain Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Facility Name
Xi'an Mental Health Center
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China
Facility Name
Shanghai Mental Health Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Facility Name
The First Affilliated Hospital Of Kunming Medical College
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650032
Country
China

12. IPD Sharing Statement

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

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