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| Sponsors and Collaborators: |
Taoyuan Mental Hospital Department of Health |
|---|---|
| Information provided by: | Taoyuan Mental Hospital |
| ClinicalTrials.gov Identifier: | NCT00621998 |
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 IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | A Randomized Controlled Trial of Risperidone and Olanzapine for the Schizophrenic Patients With Neuroleptic-Induced Tardive Dyskinesia |
| 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 |
|---|---|
|
1: Experimental
Flexible dose of olanzapine
|
Drug: olanzapine
2.5-20 mg/day
|
|
2: Active Comparator
Flexible dose of risperidone
|
Drug: risperidone
0.5-6 mg/day
|
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:
Exclusion Criteria:
Contacts and Locations More Information
| Responsible Party: | Taoyuan Mental Hospital ( Hung-Yu Chan/ Attending Psychiatry and Director of General Psychiatry ) |
| Study ID Numbers: | TMH-91-02, DOH-890010 |
| Study First Received: | February 13, 2008 |
| Last Updated: | February 13, 2008 |
| ClinicalTrials.gov Identifier: | NCT00621998 History of Changes |
| Health Authority: | Taiwan: Department of Health |
|
Risperidone Olanzapine Tardive dyskinesia |
|
Neurotransmitter Agents Tranquilizing Agents Olanzapine Risperidone Psychotropic Drugs Antiemetics Central Nervous System Diseases Central Nervous System Depressants Antipsychotic Agents Serotonin Uptake Inhibitors |
Dyskinesias Serotonin Tardive Dyskinesia Signs and Symptoms Dopamine Movement Disorders Neurologic Manifestations Dopamine Agents Peripheral Nervous System Agents Oral Facial Dyskinesia |
|
Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Olanzapine Psychotropic Drugs Antiemetics Signs and Symptoms Serotonin Antagonists Movement Disorders Therapeutic Uses Tranquilizing Agents Nervous System Diseases Gastrointestinal Agents |
Risperidone Central Nervous System Depressants Central Nervous System Diseases Dopamine Antagonists Antipsychotic Agents Dyskinesias Serotonin Uptake Inhibitors Pharmacologic Actions Serotonin Agents Autonomic Agents Neurologic Manifestations Dopamine Agents Peripheral Nervous System Agents Central Nervous System Agents |
