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

Information source: Central South University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Schizophrenia

Intervention: risperidone oral solution (Drug); haloperidol (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Central South University

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: the change of PANSS-EC scores

Secondary outcome: response rate based on the PANSS

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.

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Both.

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

Locations and Contacts

MentalHealth Institute of the 2nd Xiangya Hospital, Central South University, Changsha, Hunan 410011, China
Additional Information

Starting date: August 2008
Last updated: July 31, 2009

Page last updated: August 23, 2015

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