Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00331825
Status:
COMPLETED
Last Update Posted:
2006-05-31
First Post:
2006-05-30
Brief Title:
Risperidone and Olanzapine for the Schizophrenic Patients With Neuroleptic-Induced Acute Dystonia or Parkinsonism
Sponsor:
Taoyuan Psychiatric Center Ministry of Health and Welfare Executive Yuan ROC Taiwan
Organization:
Taoyuan Psychiatric Center Ministry of Health and Welfare Executive Yuan ROC Taiwan
Study Overview
Official Title:
A Randomized Controlled Trial Study of Risperidone and Olanzapine for the Schizophrenic Patients With Neuroleptic-Induced Acute Dystonia or Parkinsonism
Status:
COMPLETED
Status Verified Date:
2000-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| TMH-91-01 | None | None | None |