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

Sponsors and Collaborators:	Shanghai Mental Health Center Shanghai Hotmed Sciences Co.,LTD
Information provided by:	Shanghai Mental Health Center
ClinicalTrials.gov Identifier:	NCT00866645

Purpose

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.

Condition	Intervention	Phase
Agitation	Drug: Intramuscular Haloperidol Drug: Intramuscular Levosulpiride	Phase II Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Mental Health Schizophrenia

Drug Information available for: Haloperidol Levosulpiride Haloperidol decanoate Haloperidol lactate

U.S. FDA Resources

Further study details as provided by Shanghai Mental Health Center:

Primary Outcome Measures:

the change of PANSS-EC total scores [ Time Frame: from baseline to the end of study(72 hours after first dosing) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

the change of Agitation Calmness Evaluation Scale(ACES) [ Time Frame: from baseline to the end of study (72 hours after first dosing) ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: No ]
the change of PANSS total scores [ Time Frame: from baseline to the end of study (72 hours after first dosing) ] [ Designated as safety issue: No ]
the change of Brief Psychiatric Rating Scale(BPRS) total scores [ Time Frame: from baseline to the end of study (72 hours after first dosing) ] [ Designated as safety issue: No ]
the change of every item of PANSS-EC [ Time Frame: from baseline to the end of study (72 hours after first dosing) ] [ Designated as safety issue: No ]
the change of Rating Scale for Extrapyramidal Side Effect(RSESE) [ Time Frame: from baseline to the end of study (72 hours after first dosing) ] [ Designated as safety issue: Yes ]
the change of Barnes Akathisia Scale(BAS) [ Time Frame: from baseline to the end of study (72 hours after first dosing) ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	240
Study Start Date:	February 2009
Estimated Study Completion Date:	July 2009
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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.
2: Active Comparator 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.

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

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 pilepsy, 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00866645

Contacts

Contact: Niufan GU, MD	86-21-64387250 ext 3107	guniufan@yahoo.com
Contact: Huafang LI, MD, PhD	86-21-64387250 ext 3128	lhlh5@yahoo.com.cn

Locations

China
Shanghai Mental Health Center	Recruiting
Shanghai, China, 200030
Contact: Niufan GU, MD 86-21-64387250 ext 3107 guniufan@yahoo.com
Contact: Huafang LI, MD,PhD 86-21-64387250 ext 3128 lhlh5@yahoo.com.cn
Sub-Investigator: Huafang LI, MD,PhD
Sub-Investigator: Yan LI, MD
Principal Investigator: Niufan GU, MD
China, Hebei
Hebei Mental Health Center	Recruiting
Baoding, Hebei, China, 071000
Contact: Bo DU, MD 0312-5976202 db670196@sina.com
Principal Investigator: Keqing LI, MD
China, Jiangsu
Nanjing Brain Hospital	Recruiting
Nanjing, Jiangsu, China, 210029
Contact: Shiping XIE, MD 025-83700011 ext 6365 xieshiping@medmail.com.cn
Principal Investigator: Shiping XIE, MD
China, Shaanxi
Xi'an Mental Health Center	Recruiting
Xi'an, Shaanxi, China, 710061
Contact: Feihu LIU, MD 029-85551336 feihu1978@163.com
Principal Investigator: Jianguo SHI, MD
China, Yunnan
The First Affilliated Hospital Of Kunming Medical College	Recruiting
Kunming, Yunnan, China, 650032
Contact: Xiufeng XU, MD 13888261558 xfxu2004@sina.com
Principal Investigator: Xiufeng XU, MD

Sponsors and Collaborators

Shanghai Mental Health Center

Shanghai Hotmed Sciences Co.,LTD

Investigators

Study Director:

Huafang LI, MD,PhD

Drug Clinical Trial Office, Shanghai Mental Health Center

More Information

No publications provided

Responsible Party:	Shanghai Mental Health Center ( GU, Niufan )
Study ID Numbers:	2004L03556, SMHC-100
Study First Received:	March 19, 2009
Last Updated:	March 19, 2009
ClinicalTrials.gov Identifier:	NCT00866645 History of Changes
Health Authority:	China: State Food and Drug Administration

Keywords provided by Shanghai Mental Health Center:

Agitation
Schizophrenia
Randomized
Blind
Parallel
Intramuscular Haloperidol
Controlled
Multicenter
Clinical Trial
Efficacy

Safety
Intramuscular Levosulpiride
Chinese
PANSS-EC
ACES
CGI
BPRS
PANSS
RSESE
BAS

Study placed in the following topic categories:

Neurotransmitter Agents
Sulpiride
Tranquilizing Agents
Psychotropic Drugs
Central Nervous System Depressants
Antiemetics
Psychomotor Agitation
Antipsychotic Agents
Dyskinesias
Schizophrenia
Haloperidol
Signs and Symptoms

Haloperidol decanoate
Dopamine
Mental Disorders
Neurologic Manifestations
Dopamine Agents
Psychotic Disorders
Peripheral Nervous System Agents
Antidepressive Agents, Second-Generation
Neurobehavioral Manifestations
Antidepressive Agents
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Neurotransmitter Agents
Sulpiride
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Antiemetics
Psychomotor Agitation
Haloperidol
Schizophrenia
Signs and Symptoms
Mental Disorders
Therapeutic Uses
Psychomotor Disorders
Antidepressive Agents, Second-Generation

Neurobehavioral Manifestations
Antidepressive Agents
Schizophrenia and Disorders with Psychotic Features
Tranquilizing Agents
Nervous System Diseases
Gastrointestinal Agents
Central Nervous System Depressants
Dopamine Antagonists
Antipsychotic Agents
Dyskinesias
Pharmacologic Actions
Haloperidol decanoate
Autonomic Agents
Neurologic Manifestations
Dopamine Agents

ClinicalTrials.gov processed this record on August 25, 2009