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Risperidone and Olanzapine for the Schizophrenic Patients With Neuroleptic-Induced Tardive Dyskinesia

Primary Purpose

Neuroleptic-Induced Tardive Dyskinesia

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

About this trial

This is an interventional treatment trial for Neuroleptic-Induced Tardive Dyskinesia focused on measuring Risperidone, Olanzapine, Tardive dyskinesia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age of 18-70 y/o
  • Female patients did not have pregnancy plans and must agree to use reliable pregnancy prevention methods if during childbearing age
  • Meet schizophrenia, schizophreniform or schizoaffective disorder criteria of DSM-IV
  • Fulfill DSM-IV neuroleptic-induced tardive dyskinesia research criteria, the severity of tardive dyskinesia was no less than moderate degree (> or =4) assessed by global impression of Extrapyramidal System Rating Scale (item 42 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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Flexible dose of olanzapine

Flexible dose of risperidone

Outcomes

Primary Outcome Measures

Total scores of AIMS

Secondary Outcome Measures

Total scores of BPRS
Extrapyramidal syndrome rating scale

Full Information

First Posted
February 13, 2008
Last Updated
February 13, 2008
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
NCT00621998
Brief Title
Risperidone and Olanzapine for the Schizophrenic Patients With Neuroleptic-Induced Tardive Dyskinesia
Official Title
A Randomized Controlled Trial of Risperidone and Olanzapine for the Schizophrenic Patients With Neuroleptic-Induced Tardive Dyskinesia
Study Type
Interventional

2. Study Status

Record Verification Date
February 2000
Overall Recruitment Status
Completed
Study Start Date
July 2000 (undefined)
Primary Completion Date
December 2003 (Actual)
Study Completion Date
June 2004 (Actual)

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

Data Monitoring Committee
Yes

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 effects of these 2 drugs in schizophrenic spectrum patients of Han ethnics with neuroleptic-induced tardive dyskinesia to test the hypothesis that these two medications have different effects in improving tardive dyskinesia.
Detailed Description
Objective: First generation antipsychotics would induce tardive dyskinesia in some schizophrenic patients. Second generation antipsychotics were the choices for these 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 neuroleptic-induced tardive dyskinesia to see their effects in improving tardive dyskinesia. We also collected the data of average dose of risperidone and olanzapine to help the dosing strategy guidelines for the schizophrenic patients with neuroleptic-induced tardive dyskinesia. Method: This randomized, rater-blind, parallel group, flexible dose study enrolled patients from Taoyuan Mental Hospital from July 2000 to December 2003. Schizophrenia, schizophreniform or schizoaffective disorder (DSM-IV) patients who met the research criteria of neuroleptic-induced tardive dyskinesia research criteria of DSM-IV and no less than moderate severity (> or =4) of global impression of extrapyramidal syndrome rating scale (ESRS). 60 patients were random assignment to risperidone or olanzapine for 24 weeks. The primary outcome was to compare the change of total scores of abnormal involuntary movement scale from baseline to study endpoint.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuroleptic-Induced Tardive Dyskinesia
Keywords
Risperidone, Olanzapine, Tardive dyskinesia

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Flexible dose of olanzapine
Arm Title
2
Arm Type
Active Comparator
Arm Description
Flexible dose of risperidone
Intervention Type
Drug
Intervention Name(s)
risperidone
Intervention Description
0.5-6 mg/day
Intervention Type
Drug
Intervention Name(s)
olanzapine
Intervention Description
2.5-20 mg/day
Primary Outcome Measure Information:
Title
Total scores of AIMS
Time Frame
The change from baseline to study endpoint
Secondary Outcome Measure Information:
Title
Total scores of BPRS
Time Frame
The change from baseline to study endpoint
Title
Extrapyramidal syndrome rating scale
Time Frame
The change from baseline to study endpoint

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age of 18-70 y/o Female patients did not have pregnancy plans and must agree to use reliable pregnancy prevention methods if during childbearing age Meet schizophrenia, schizophreniform or schizoaffective disorder criteria of DSM-IV Fulfill DSM-IV neuroleptic-induced tardive dyskinesia research criteria, the severity of tardive dyskinesia was no less than moderate degree (> or =4) assessed by global impression of Extrapyramidal System Rating Scale (item 42 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., M.S.
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
33058
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
20441726
Citation
Chan HY, Chiang SC, Chang CJ, Gau SS, Chen JJ, Chen CH, Hwu HG, Lai MS. A randomized controlled trial of risperidone and olanzapine for schizophrenic patients with neuroleptic-induced tardive dyskinesia. J Clin Psychiatry. 2010 Sep;71(9):1226-33. doi: 10.4088/jcp.09m05155yel.
Results Reference
derived

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Risperidone and Olanzapine for the Schizophrenic Patients With Neuroleptic-Induced Tardive Dyskinesia

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