Official Title: “Efficacy and Safety of Risperidone Oral Solution Combination Clonazepam Versus Haloperidol IM Injection for Treatment of Acute Psychotic Agitation in Schizophrenia”

This is a multi-centre, open, randomized, haloperidol-referenced, 47 days two treatment sessions, parallel-group study.

After screening period, eligible subjects will be entered 5 days treatment session I to compare the efficacy between risperidone oral solution combination clonazepam oral and haloperidol IM injection on controlling psychotic agitation, then will be followed by 6 additional weeks treatment session II for exploring the effect of medicine switching from IM injection to oral.

Study Type: Interventional

Study Design: Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: March 2009

Acute psychotic agitation is a common problem in many patients with schizophrenia that includes agitation, aggression, excitement and violence. An investigation showed that about 26% psychotic patients were brought to the psychiatric emergency room because of the psychotic agitation symptoms. The primary objective is to compare the efficacy between risperidone oral solution combination clonazepam oral and haloperidol IM injection on controlling psychotic agitation in patients of acute schizophrenia and schizophrenic-affective disorder.

The secondary objectives are: (1) to explore the possibility of decreasing efficacy of acute 6 weeks treatment from IM injection to oral; (2) to compare the safety between risperidone oral solution combination clonazepam oral and haloperidol IM injection.

Intervention(s) in this Clinical Trial

• Drug: risperidone oral solution
  • risperidone oral solution (2-6mg/d) combination clonazepam (4-8mg/d) oral
• Drug: haloperidol
  • haloperidol IM injection (5-20mg/d)

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: oral group
  • risperidone oral solution combination clonazepam oral
• Active Comparator: IM group
  • haloperidol IM injection

Primary Measures

• the change of PANSS-EC scores
  • Time Frame: 5 days
    Safety Issue?: No

Secondary Measures

• response rate based on the PANSS
  • Time Frame: 47 days
    Safety Issue?: No

Inclusion Criteria:

• Men or women aged 18 to 45 years
• DSM-IV diagnosis of acute exacerbation of schizophrenia or schizoaffective disorders
• A score of ≥ 14 on a 5-item acute-agitation cluster (including excitement, hostility, uncooperativeness and poor impulse control) derived from the PNASS
• The total scores ≥60 on the PANSS

Exclusion Criteria:

• Women who are pregnant or breast feeding, or who plan to become pregnant during the study
• The psychotic agitation is caused by delirium, epilepsy, mental retardation and affective disorder; intoxication or symptoms of withdrawal from alcohol or other psychoactive substances
• Clinical laboratory values indicating serious medical illness
• Known hypersensitivity to any of the study medications
• Treatment with a depot antipsychotic with 1 cycle of screening
• Using of disallowed medication

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 45 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Central South University

Information obtained from ClinicalTrials.gov on February 08, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00859872

Study ID Number: IIS-0801

ClinicalTrials.gov Identifier: NCT00859872

Health Authority: China: State Food and Drug Administration