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

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
risperidone oral solution
haloperidol
Sponsored by
Central South University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring acute psychotic agitation, schizophrenia, risperidone oral solution, clonazepam, haloperidol

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • MentalHealth Institute of the 2nd Xiangya Hospital, Central South University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

oral group

IM group

Arm Description

risperidone oral solution combination clonazepam oral

haloperidol IM injection

Outcomes

Primary Outcome Measures

the change of PANSS-EC scores

Secondary Outcome Measures

response rate based on the PANSS

Full Information

First Posted
March 10, 2009
Last Updated
July 31, 2009
Sponsor
Central South University
Collaborators
Wuhan Mental Health Institute, Capital Medical University, Shanghai Mental Health Center, Guangzhou Mental Hospital, Chongqing Mental Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00859872
Brief Title
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

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Central South University
Collaborators
Wuhan Mental Health Institute, Capital Medical University, Shanghai Mental Health Center, Guangzhou Mental Hospital, Chongqing Mental Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
acute psychotic agitation, schizophrenia, risperidone oral solution, clonazepam, haloperidol

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
198 (Actual)

8. Arms, Groups, and Interventions

Arm Title
oral group
Arm Type
Experimental
Arm Description
risperidone oral solution combination clonazepam oral
Arm Title
IM group
Arm Type
Active Comparator
Arm Description
haloperidol IM injection
Intervention Type
Drug
Intervention Name(s)
risperidone oral solution
Intervention Description
risperidone oral solution (2-6mg/d) combination clonazepam (4-8mg/d) oral
Intervention Type
Drug
Intervention Name(s)
haloperidol
Intervention Description
haloperidol IM injection (5-20mg/d)
Primary Outcome Measure Information:
Title
the change of PANSS-EC scores
Time Frame
5 days
Secondary Outcome Measure Information:
Title
response rate based on the PANSS
Time Frame
47 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
MentalHealth Institute of the 2nd Xiangya Hospital, Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410011
Country
China

12. IPD Sharing Statement

Learn more about this trial

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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