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

Central South University

Status and phase

Completed

Phase 4

Conditions

Schizophrenia

Treatments

Drug: haloperidol

Drug: risperidone oral solution

Study type

Interventional

Funder types

Other

Identifiers

NCT00859872

IIS-0801

Details and patient eligibility

About

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.

Full description

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.

Enrollment

198 patients

Sex

All

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

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