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

Information source: Shanghai Mental Health Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Agitation

Intervention: Intramuscular Haloperidol (Drug); Intramuscular Levosulpiride (Drug)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: Shanghai Mental Health Center

Official(s) and/or principal investigator(s):
Huafang LI, MD,PhD, Study Director, Affiliation: Drug Clinical Trial Office, Shanghai Mental Health Center

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.

Clinical Details

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

Primary outcome: the change of PANSS-EC total scores

Secondary outcome:

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)

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 ]

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

Hebei Mental Health Center, Baoding, Hebei 071000, China

Nanjing Brain Hospital, Nanjing, Jiangsu 210029, China

Xi'an Mental Health Center, Xi'an, Shaanxi 710061, China

Shanghai Mental Health Center, Shanghai, Shanghai 200030, China

The First Affilliated Hospital Of Kunming Medical College, Kunming, Yunnan 650032, China

Additional Information

Starting date: February 2009
Last updated: December 2, 2010

Page last updated: August 23, 2015

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