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| Sponsors and Collaborators: |
Taoyuan Mental Hospital Department of Health |
|---|---|
| Information provided by: | Taoyuan Mental Hospital |
| ClinicalTrials.gov Identifier: | NCT00331825 |
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 incidence of using anticholinergic drugs in schizophrenic patients of Han ethnics with neuroleptic-induced acute dystonia or parkinsonism to test the hypothesis that these two medications have different EPS incidence in EPS intolerant population.
| Condition | Intervention | Phase |
|---|---|---|
|
Schizophrenia Extrapyramidal Syndrome |
Drug: Risperidone and Olanzapine |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Randomized Controlled Trial Study of Risperidone and Olanzapine for the Schizophrenic Patients With Neuroleptic-Induced Acute Dystonia or Parkinsonism |
| Estimated Enrollment: | 70 |
| Study Start Date: | July 2000 |
| Estimated Study Completion Date: | July 2003 |
Objective: First generation antipsychotics frequently induced extrapyramidal side effects (EPS). Second generation antipsychotics were the choices for EPS intolerant schizophrenic 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 acute dystonia or parkinsonism side effects and observed the incidence of needing concomitant anticholinergic drugs. We also collected the data of average dose of risperidone and olanzapine to help the dosing strategy guidelines for EPS intolerant schizophrenic patients.
Method: This randomized, rater-blind, parallel group, flexible dose study enrolled patients from Taoyuan Mental Hospital from July 2000 to July 2003. Schizophrenia (DSM-IV) patients who met the research criteria of neuroleptic-induced acute dystonia or parkinsonism research criteria of DSM-IV and greater than moderate severity (＞4) of global impression of extrapyramidal syndrome rating scale (ESRS). 70 patients were random assignment to risperidone or olanzapine for 8 weeks. The primary outcome was to compare the incidence of concomitant anticholinergic drugs.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations More Information
| Study ID Numbers: | DOH-890010, TMH-91-01 |
| Study First Received: | May 30, 2006 |
| Last Updated: | May 30, 2006 |
| ClinicalTrials.gov Identifier: | NCT00331825 |
| Health Authority: | Taiwan: Department of Health |
|
Schizophrenia, EPS, risperidone, olanzapine |
|
Dystonic Disorders Ganglion Cysts Basal Ganglia Diseases Risperidone Olanzapine Dystonia Central Nervous System Diseases Brain Diseases |
Serotonin Schizophrenia Dopamine Mental Disorders Movement Disorders Psychotic Disorders Parkinsonian Disorders Schizophrenia and Disorders with Psychotic Features |
|
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Disease Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Nervous System Diseases Physiological Effects of Drugs Gastrointestinal Agents Psychotropic Drugs Antiemetics Central Nervous System Depressants Dopamine Antagonists |
Antipsychotic Agents Serotonin Uptake Inhibitors Pharmacologic Actions Serotonin Antagonists Pathologic Processes Serotonin Agents Autonomic Agents Therapeutic Uses Syndrome Dopamine Agents Peripheral Nervous System Agents Central Nervous System Agents |
