Clinical trial NCT00859872: Efficacy and Safety of Risperidone Oral Solution Combination Clonazepam Versus Haloperidol Intramuscular (IM) Injection for Treatment of Acute Psychotic Agitation in Schizophrenia
Official title: Efficacy and Safety of Risperidone Oral Solution Combination Clonazepam Versus Haloperidol IM Injection for Treatment of Acute Psychotic Agitation in Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Keywords: acute psychotic agitation
schizophrenia
risperidone oral solution
clonazepam
haloperidol
Lead sponsor: Central South University
Sponsor class: OTHER
Collaborators: name: Wuhan Mental Health Institute
name: Capital Medical University
name: Shanghai Mental Health Center
name: Guangzhou Mental Hospital
name: Chongqing Mental Hospital
First posted: 2009-03-11
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: the change of PANSS-EC scores
timeFrame: 5 days
Secondary outcomes:
measure: response rate based on the PANSS
timeFrame: 47 days
Other outcomes:
Locations:
city: Changsha
country: China
facility: MentalHealth Institute of the 2nd Xiangya Hospital, Central South University
state: Hunan
Study officials:
References: