Efficacy and Safety of Risperidone Oral Solution Combinat... | NCT00859872

Status Module

Record Verification Date

Jul 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2008

Primary Completion Date

Mar 2009Actual

Completion Date

Mar 2009Actual

First Submitted Date

Mar 10, 2009

First Submission Date that Met QC Criteria

Mar 10, 2009

First Posted Date

Mar 11, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 31, 2009

Last Update Posted Date

Aug 3, 2009Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Central South UniversityOTHER

Collaborators

Name	Class
Wuhan Mental Health Centre	OTHER
Capital Medical University	OTHER
Shanghai Mental Health Center	OTHER
Guangzhou Mental Hospital

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

198Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
oral group	Experimental	risperidone oral solution combination clonazepam oral	Drug: risperidone oral solution
IM group	Active Comparator	haloperidol IM injection	Drug: haloperidol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
risperidone oral solution	Drug	risperidone oral solution (2-6mg/d) combination clonazepam (4-8mg/d) oral	oral group

Measure	Description	Time Frame
the change of PANSS-EC scores		5 days

Measure	Description	Time Frame
response rate based on the PANSS		47 days

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
MentalHealth Institute of the 2nd Xiangya Hospital, Central South University		Changsha	Hunan	410011	China

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders

ID	Term
D018967	Risperidone
D006220	Haloperidol

ID	Term
D011744	Pyrimidinones
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D002090	Butyrophenones
D007659	Ketones
D009930	Organic Chemicals