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

Phase 4

Completed

• Conditions: Schizophrenia
• Interventions: Drug: risperidone oral solution; Drug: haloperidol

• Registration Number: NCT00859872
• Lead Sponsor: Central South University

Brief Summary

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

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.

Study Timeline

• Study Start: 2008-08
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Study First Submitted: 2009-03-10
• Study First Submitted QC: 2009-03-10
• Study First Posted: 2009-03-11
• Status Verified: 2009-07
• Last Update Submitted: 2009-07-31
• Last Update Posted: 2009-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 198

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
oral group	risperidone oral solution	risperidone oral solution combination clonazepam oral
IM group	haloperidol	haloperidol IM injection

Primary Outcome Measures

Name	Time	Method
the change of PANSS-EC scores	5 days

Secondary Outcome Measures

Name	Time	Method
response rate based on the PANSS	47 days

Trial Locations

Locations (1)

MentalHealth Institute of the 2nd Xiangya Hospital, Central South University; 🇨🇳 Changsha, Hunan, China