Efficacy and Safety of Risperidone Oral Solution Combination Clonazepam Versus Haloperidol Intramuscular (IM) Injection for Treatment of Acute Psychotic Agitation in Schizophrenia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: risperidone oral solution
* Drug: haloperidol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: oral group<br>risperidone oral solution combination clonazepam oral | Drug: risperidone oral solution<br>* risperidone oral solution (2-6mg/d) combination clonazepam (4-8mg/d) oral<br>|
| Active Comparator: IM group<br>haloperidol IM injection | Drug: haloperidol<br>* haloperidol IM injection (5-20mg/d)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the change of PANSS-EC scores |  | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| response rate based on the PANSS |  | 47 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute psychotic agitation, schizophrenia, risperidone oral solution, clonazepam, haloperidol