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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

198 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2009-03-31

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.

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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.

Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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oral group

risperidone oral solution combination clonazepam oral

Group Type EXPERIMENTAL

risperidone oral solution

Intervention Type DRUG

risperidone oral solution (2-6mg/d) combination clonazepam (4-8mg/d) oral

IM group

haloperidol IM injection

Group Type ACTIVE_COMPARATOR

haloperidol

Intervention Type DRUG

haloperidol IM injection (5-20mg/d)

Interventions

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risperidone oral solution

risperidone oral solution (2-6mg/d) combination clonazepam (4-8mg/d) oral

Intervention Type DRUG

haloperidol

haloperidol IM injection (5-20mg/d)

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No