Risperidone and Olanzapine for the Schizophrenic Patients With Neuroleptic-Induced Acute Dystonia or Parkinsonism

Schizophrenia Clinical Trial

Official title:

A Randomized Controlled Trial Study of Risperidone and Olanzapine for the Schizophrenic Patients With Neuroleptic-Induced Acute Dystonia or Parkinsonism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00331825
• Other study ID #: DOH-890010
• Secondary ID: TMH-91-01
• Status: Completed
• Phase: Phase 4
• First received: May 30, 2006
• Last updated: May 30, 2006
• Start date: July 2000
• Est. completion date: July 2003

Study information

• Verified date: February 2000
• Source: Taoyuan Psychiatric Center, Ministry of Health and Welfare, Executive Yuan, R.O.C. Taiwan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: July 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Age of 18-65 y/o;

• Female patients did not have pregnancy plans and must agree to use reliable pregnancy prevention methods if during childbearing age;

• Meet schizophrenia criteria of DSM-IV;

• Fulfill DSM-IV neuroleptic-induced acute dystonia or parkinsonism research criteria, the severity of acute dystonia or parkinsonism was greater than moderate degree (>4) assessed by global impression of Extrapyramidal System Rating Scale (item 43 and 44 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Basal Ganglia Diseases
• Extrapyramidal Syndrome
• Parkinsonian Disorders
• Schizophrenia

Intervention

Drug:
• Risperidone and Olanzapine

Locations

Country	Name	City	State
Taiwan	Taoyuan Mental Hospital	Taoyuan

Sponsors (2)

Lead Sponsor	Collaborator
Taoyuan Psychiatric Center, Ministry of Health and Welfare, Executive Yuan, R.O.C. Taiwan	Department of Health

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of using concomitant anticholinergic drugs
Secondary	Scores of Rating Scale (Extrapyramidal System Rating Scale, Brief Psychiatric Rating Scale)