Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00859872
Recruitment Status : Completed
First Posted : March 11, 2009
Last Update Posted : August 3, 2009
Sponsor:
Collaborators:
Wuhan Mental Health Institute
Capital Medical University
Shanghai Mental Health Center
Guangzhou Mental Hospital
Chongqing Mental Hospital
Information provided by:
Central South University

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.


Condition or disease Intervention/treatment Phase
Schizophrenia Drug: risperidone oral solution Drug: haloperidol Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 198 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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


Arm Intervention/treatment
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
Drug: haloperidol
haloperidol IM injection (5-20mg/d)




Primary Outcome Measures :
  1. the change of PANSS-EC scores [ Time Frame: 5 days ]

Secondary Outcome Measures :
  1. response rate based on the PANSS [ Time Frame: 47 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
Layout table for location information
China, Hunan
MentalHealth Institute of the 2nd Xiangya Hospital, Central South University
Changsha, Hunan, China, 410011
Sponsors and Collaborators
Central South University
Wuhan Mental Health Institute
Capital Medical University
Shanghai Mental Health Center
Guangzhou Mental Hospital
Chongqing Mental Hospital
Layout table for additonal information
Responsible Party: MentalHealth Institute of the 2nd Xiangya Hospital, Central South University, the 2nd Xiangya Hospital, Central South University
ClinicalTrials.gov Identifier: NCT00859872    
Other Study ID Numbers: IIS-0801
First Posted: March 11, 2009    Key Record Dates
Last Update Posted: August 3, 2009
Last Verified: July 2009
Keywords provided by Central South University:
acute psychotic agitation
schizophrenia
risperidone oral solution
clonazepam
haloperidol
Additional relevant MeSH terms:
Layout table for MeSH terms
Psychomotor Agitation
Schizophrenia
Mental Disorders
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Haloperidol
Risperidone
Haloperidol decanoate
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Anti-Dyskinesia Agents