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

NCT00866645 | Completed Phase 2

• 2 other identifiers: 2004L03556SMHC-100
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 5

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• the change of PANSS-EC total scores

  from baseline to the end of study(72 hours after first dosing)

Secondary Outcomes (7)

• the change of Agitation Calmness Evaluation Scale(ACES)

  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)

  from baseline to the end of study (72 hours after first dosing)

• the change of PANSS total scores

  from baseline to the end of study (72 hours after first dosing)

• the change of Brief Psychiatric Rating Scale(BPRS) total scores

  from baseline to the end of study (72 hours after first dosing)

• the change of every item of PANSS-EC

  from baseline to the end of study (72 hours after first dosing)

Study Arms (2)

1

EXPERIMENTAL

Intramuscular Levosulpiride

Drug: Intramuscular Levosulpiride

2

ACTIVE COMPARATOR

Intramuscular Haloperidol

Drug: Intramuscular Haloperidol

Interventions

Intramuscular Haloperidol DRUG

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.

Also known as: Intramuscular Haloperidol parenteral solution

2

Intramuscular Levosulpiride DRUG

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.

Also known as: Intramuscular Levosulpiride parenteral solution

1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Mental Health Center: lead
• Shanghai Hotmed Sciences Co.,LTD: collaborator

Study Sites (5)

Hebei Mental Health Center

Baoding, Hebei, 071000, China

Location

Nanjing Brain Hospital

Nanjing, Jiangsu, 210029, China

Location

Xi'an Mental Health Center

Xi'an, Shaanxi, 710061, China

Location

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

Location

The First Affilliated Hospital Of Kunming Medical College

Kunming, Yunnan, 650032, China

Location

MeSH Terms

Conditions

Psychomotor Agitation; Schizophrenia

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Huafang LI, MD,PhD

  Drug Clinical Trial Office, Shanghai Mental Health Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 19, 2009
• First Posted: March 20, 2009
• Study Start: February 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: December 3, 2010

Record last verified: 2010-12

Locations

CN (5)