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Risperidone and Olanzapine for the Schizophrenic Patients With Neuroleptic-Induced Acute Dystonia or Parkinsonism

Primary Purpose

Schizophrenia, Extrapyramidal Syndrome

Status
Completed
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Risperidone and Olanzapine
Sponsored by
Taoyuan Psychiatric Center, Ministry of Health and Welfare, Executive Yuan, R.O.C. Taiwan
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, EPS, risperidone, olanzapine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age of 18-65 y/o; Female patients did not have pregnancy plans and must agree to use reliable pregnancy prevention methods if during childbearing age; Meet schizophrenia criteria of DSM-IV; Fulfill DSM-IV neuroleptic-induced acute dystonia or parkinsonism research criteria, the severity of acute dystonia or parkinsonism was greater than moderate degree (>4) assessed by global impression of Extrapyramidal System Rating Scale (item 43 and 44 of ESRS); Patients or legal responsible people agree to join study and sign informed consent Exclusion Criteria: Had other axis I diagnosis of DSM-IV; Unstable major systemic diseases; Had neurological disorder influenced to EPS assessment; Substance abuse or dependence other then coffee or tobacco within 6 months before study

Sites / Locations

  • Taoyuan Mental Hospital

Outcomes

Primary Outcome Measures

Percentage of using concomitant anticholinergic drugs

Secondary Outcome Measures

Scores of Rating Scale (Extrapyramidal System Rating Scale, Brief Psychiatric Rating Scale)

Full Information

First Posted
May 30, 2006
Last Updated
May 30, 2006
Sponsor
Taoyuan Psychiatric Center, Ministry of Health and Welfare, Executive Yuan, R.O.C. Taiwan
Collaborators
Department of Health
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1. Study Identification

Unique Protocol Identification Number
NCT00331825
Brief Title
Risperidone and Olanzapine for the Schizophrenic Patients With Neuroleptic-Induced Acute Dystonia or Parkinsonism
Official Title
A Randomized Controlled Trial Study of Risperidone and Olanzapine for the Schizophrenic Patients With Neuroleptic-Induced Acute Dystonia or Parkinsonism
Study Type
Interventional

2. Study Status

Record Verification Date
February 2000
Overall Recruitment Status
Completed
Study Start Date
July 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2003 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Taoyuan Psychiatric Center, Ministry of Health and Welfare, Executive Yuan, R.O.C. Taiwan
Collaborators
Department of Health

4. Oversight

5. Study Description

Brief Summary
We initiate a study with research grant from department of health and Taoyuan mental hospital and choose risperidone and olanzapine as study medications. We compare the incidence of using anticholinergic drugs in schizophrenic patients of Han ethnics with neuroleptic-induced acute dystonia or parkinsonism to test the hypothesis that these two medications have different EPS incidence in EPS intolerant population.
Detailed Description
Objective: First generation antipsychotics frequently induced extrapyramidal side effects (EPS). Second generation antipsychotics were the choices for EPS intolerant schizophrenic patients. But which one of second generation antipsychotic was the better choice did not have definitive results. We compared risperidone and olanzapine in schizophrenic patients with acute dystonia or parkinsonism side effects and observed the incidence of needing concomitant anticholinergic drugs. We also collected the data of average dose of risperidone and olanzapine to help the dosing strategy guidelines for EPS intolerant schizophrenic patients. Method: This randomized, rater-blind, parallel group, flexible dose study enrolled patients from Taoyuan Mental Hospital from July 2000 to July 2003. Schizophrenia (DSM-IV) patients who met the research criteria of neuroleptic-induced acute dystonia or parkinsonism research criteria of DSM-IV and greater than moderate severity (>4) of global impression of extrapyramidal syndrome rating scale (ESRS). 70 patients were random assignment to risperidone or olanzapine for 8 weeks. The primary outcome was to compare the incidence of concomitant anticholinergic drugs.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Extrapyramidal Syndrome
Keywords
Schizophrenia, EPS, risperidone, olanzapine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
70 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Risperidone and Olanzapine
Primary Outcome Measure Information:
Title
Percentage of using concomitant anticholinergic drugs
Secondary Outcome Measure Information:
Title
Scores of Rating Scale (Extrapyramidal System Rating Scale, Brief Psychiatric Rating Scale)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age of 18-65 y/o; Female patients did not have pregnancy plans and must agree to use reliable pregnancy prevention methods if during childbearing age; Meet schizophrenia criteria of DSM-IV; Fulfill DSM-IV neuroleptic-induced acute dystonia or parkinsonism research criteria, the severity of acute dystonia or parkinsonism was greater than moderate degree (>4) assessed by global impression of Extrapyramidal System Rating Scale (item 43 and 44 of ESRS); Patients or legal responsible people agree to join study and sign informed consent Exclusion Criteria: Had other axis I diagnosis of DSM-IV; Unstable major systemic diseases; Had neurological disorder influenced to EPS assessment; Substance abuse or dependence other then coffee or tobacco within 6 months before study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hung-Yu Chan, M.D.
Organizational Affiliation
Taoyuan Psychiatric Center, Ministry of Health and Welfare, Executive Yuan, R.O.C. Taiwan
Official's Role
Study Chair
Facility Information:
Facility Name
Taoyuan Mental Hospital
City
Taoyuan
ZIP/Postal Code
330
Country
Taiwan

12. IPD Sharing Statement

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Risperidone and Olanzapine for the Schizophrenic Patients With Neuroleptic-Induced Acute Dystonia or Parkinsonism

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