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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00859872

Enrollment

198

Registered

2009-03-11

Start date

2008-08-31

Completion date

2009-03-31

Last updated

2009-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

acute psychotic agitation, schizophrenia, risperidone oral solution, clonazepam, haloperidol

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.

Interventions

DRUGrisperidone oral solution

risperidone oral solution (2-6mg/d) combination clonazepam (4-8mg/d) oral

DRUGhaloperidol

haloperidol IM injection (5-20mg/d)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
the change of PANSS-EC scores	5 days

Secondary

Measure	Time frame
response rate based on the PANSS	47 days

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026