Status:
COMPLETED
Efficacy and Safety of Risperidone Oral Solution Combination Clonazepam Versus Haloperidol Intramuscular (IM) Injection for Treatment of Acute Psychotic Agitation in Schizophrenia
Lead Sponsor:
Central South University
Collaborating Sponsors:
Wuhan Mental Health Institute
Capital Medical University
Conditions:
Schizophrenia
Eligibility:
All Genders
18-45 years
Phase:
PHASE4
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 sess...
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 patient...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
198 Patients enrolled
Trial Details
Trial ID
NCT00859872
Start Date
August 1 2008
End Date
March 1 2009
Last Update
August 3 2009
Active Locations (1)
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1
MentalHealth Institute of the 2nd Xiangya Hospital, Central South University
Changsha, Hunan, China, 410011