Neuroleptic-Induced Tardive Dyskinesia
Conditions
Keywords
Risperidone, Olanzapine, Tardive dyskinesia
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.
Interventions
DRUGrisperidone
0.5-6 mg/day
DRUGolanzapine
2.5-20 mg/day
Sponsors
Department of Health
Taoyuan Psychiatric Center, Ministry of Health and Welfare, Executive Yuan, R.O.C. Taiwan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total scores of AIMS | The change from baseline to study endpoint |
Secondary
| Measure | Time frame |
|---|---|
| Total scores of BPRS | The change from baseline to study endpoint |
| Extrapyramidal syndrome rating scale | The change from baseline to study endpoint |
Countries
Taiwan
Outcome results
None listed