Risperidone and Olanzapine for the Schizophrenic Patients With Neuroleptic-Induced Tardive Dyskinesia
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Neuroleptic-Induced Tardive Dyskinesia |
Drug: risperidone Drug: olanzapine |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Randomized Controlled Trial of Risperidone and Olanzapine for the Schizophrenic Patients With Neuroleptic-Induced Tardive Dyskinesia |
- Total scores of AIMS [ Time Frame: The change from baseline to study endpoint ] [ Designated as safety issue: No ]
- Total scores of BPRS [ Time Frame: The change from baseline to study endpoint ] [ Designated as safety issue: No ]
- Extrapyramidal syndrome rating scale [ Time Frame: The change from baseline to study endpoint ] [ Designated as safety issue: Yes ]
| Enrollment: | 60 |
| Study Start Date: | July 2000 |
| Study Completion Date: | June 2004 |
| Primary Completion Date: | December 2003 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Flexible dose of olanzapine
|
Drug: olanzapine
2.5-20 mg/day
|
|
Active Comparator: 2
Flexible dose of risperidone
|
Drug: risperidone
0.5-6 mg/day
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and Locations More Information
No publications provided by Taoyuan Mental Hospital
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Hung-Yu Chan/ Attending Psychiatry and Director of General Psychiatry, Taoyuan Mental Hospital |
| ClinicalTrials.gov Identifier: | NCT00621998 History of Changes |
| Other Study ID Numbers: | TMH-91-02, DOH-890010 |
| Study First Received: | February 13, 2008 |
| Last Updated: | February 13, 2008 |
| Health Authority: | Taiwan: Department of Health |
Keywords provided by Taoyuan Mental Hospital:
|
Risperidone Olanzapine Tardive dyskinesia |
Additional relevant MeSH terms:
|
Dyskinesias Movement Disorders Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Signs and Symptoms Antipsychotic Agents Risperidone Olanzapine Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents |
Therapeutic Uses Psychotropic Drugs Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Dopamine Antagonists Dopamine Agents Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Antiemetics Autonomic Agents Peripheral Nervous System Agents Gastrointestinal Agents |
ClinicalTrials.gov processed this record on June 18, 2013