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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized Controlled Trial of Risperidone and Olanzapine for the Schizophrenic Patients With Neuroleptic-Induced Tardive Dyskinesia

Conditions
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Neuroleptic-Induced Tardive Dyskinesia

Intervention / Treatment
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* Drug: risperidone
* Drug: olanzapine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Flexible dose of olanzapine | Drug: olanzapine<br>* 2.5-20 mg/day<br>|
| Active Comparator: 2<br>Flexible dose of risperidone | Drug: risperidone<br>* 0.5-6 mg/day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total scores of AIMS |  | The change from baseline to study endpoint | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total scores of BPRS |  | The change from baseline to study endpoint | 
| Extrapyramidal syndrome rating scale |  | The change from baseline to study endpoint | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Risperidone, Olanzapine, Tardive dyskinesia