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

December 2, 2010 updated by: Shanghai Mental Health Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

240

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hebei
      • Baoding, Hebei, China, 071000
        • Hebei Mental Health Center
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Nanjing Brain Hospital
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • Xi'an Mental Health Center
    • Shanghai
      • Shanghai, Shanghai, China, 200030
        • Shanghai Mental Health Center
    • Yunnan
      • Kunming, Yunnan, China, 650032
        • The First Affilliated Hospital of Kunming Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Intramuscular Levosulpiride
Drug: 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 Names:
  • Intramuscular Levosulpiride parenteral solution
ACTIVE_COMPARATOR: 2
Intramuscular Haloperidol
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.
Other Names:
  • Intramuscular Haloperidol parenteral solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the change of PANSS-EC total scores
Time Frame: from baseline to the end of study(72 hours after first dosing)
from baseline to the end of study(72 hours after first dosing)

Secondary Outcome Measures

Outcome Measure
Time Frame
the change of Agitation Calmness Evaluation Scale(ACES)
Time Frame: from baseline to the end of study (72 hours after first dosing)
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)
Time Frame: from baseline to the end of study (72 hours after first dosing)
from baseline to the end of study (72 hours after first dosing)
the change of PANSS total scores
Time Frame: from baseline to the end of study (72 hours after first dosing)
from baseline to the end of study (72 hours after first dosing)
the change of Brief Psychiatric Rating Scale(BPRS) total scores
Time Frame: from baseline to the end of study (72 hours after first dosing)
from baseline to the end of study (72 hours after first dosing)
the change of every item of PANSS-EC
Time Frame: from baseline to the end of study (72 hours after first dosing)
from baseline to the end of study (72 hours after first dosing)
the change of Rating Scale for Extrapyramidal Side Effect(RSESE)
Time Frame: from baseline to the end of study (72 hours after first dosing)
from baseline to the end of study (72 hours after first dosing)
the change of Barnes Akathisia Scale(BAS)
Time Frame: from baseline to the end of study (72 hours after first dosing)
from baseline to the end of study (72 hours after first dosing)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Mental Health Center

Collaborators

Shanghai Hotmed Sciences Co.,LTD

Investigators

  • Study Director: Huafang LI, MD,PhD, Drug Clinical Trial Office, Shanghai Mental Health Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (ACTUAL)

July 1, 2010

Study Completion (ACTUAL)

July 1, 2010

Study Registration Dates

First Submitted

March 19, 2009

First Submitted That Met QC Criteria

March 19, 2009

First Posted (ESTIMATE)

March 20, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

December 3, 2010

Last Update Submitted That Met QC Criteria

December 2, 2010

Last Verified

December 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2004L03556
  • SMHC-100

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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