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

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Central South University
• Collaborators: Capital Medical University; Chongqing Mental Hospital; Guangzhou Mental Hospital; Shanghai Mental Health Center; Wuhan Mental Health Institute
• Treatments: Clonazepam; Haloperidol; Haloperidol decanoate; Pharmaceutical Solutions; Risperidone

Criteria

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