Efficacy and Safety of Risperidone Oral Solution Combination Clonazepam Versus Haloperidol Intramuscular (IM) Injection for Treatment of Acute Psychotic Agitation in Schizophrenia
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|ClinicalTrials.gov Identifier: NCT00859872|
Recruitment Status : Completed
First Posted : March 11, 2009
Last Update Posted : August 3, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Drug: risperidone oral solution Drug: haloperidol||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||198 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Efficacy and Safety of Risperidone Oral Solution Combination Clonazepam Versus Haloperidol IM Injection for Treatment of Acute Psychotic Agitation in Schizophrenia|
|Study Start Date :||August 2008|
|Actual Primary Completion Date :||March 2009|
|Actual Study Completion Date :||March 2009|
Experimental: oral group
risperidone oral solution combination clonazepam oral
Drug: risperidone oral solution
risperidone oral solution (2-6mg/d) combination clonazepam (4-8mg/d) oral
Active Comparator: IM group
haloperidol IM injection
haloperidol IM injection (5-20mg/d)
- the change of PANSS-EC scores [ Time Frame: 5 days ]
- response rate based on the PANSS [ Time Frame: 47 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00859872
|MentalHealth Institute of the 2nd Xiangya Hospital, Central South University|
|Changsha, Hunan, China, 410011|