NCT00621998

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Taoyuan Psychiatric Center, Ministry of Health and Welfare, Executive Yuan, R.O.C. Taiwan · Other Government
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neuroleptic-Induced Tardive Dyskinesia

Interventions

Type	Name	Description
DRUG	risperidone	0.5-6 mg/day
DRUG	olanzapine	2.5-20 mg/day

Timeline

• Start date: 2000-07-01
• Primary completion: 2003-12-01
• Completion: 2004-06-01
• First posted: 2008-02-22
• Last updated: 2008-02-22

Locations

1 site across 1 country: Taiwan