NCT00859872

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 198 (actual)
• Sponsor: Central South University · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	risperidone oral solution	risperidone oral solution (2-6mg/d) combination clonazepam (4-8mg/d) oral
DRUG	haloperidol	haloperidol IM injection (5-20mg/d)

Timeline

• Start date: 2008-08-01
• Primary completion: 2009-03-01
• Completion: 2009-03-01
• First posted: 2009-03-11
• Last updated: 2009-08-03

Locations

1 site across 1 country: China