Risperidone and Olanzapine for the Schizophrenic Patients With Neuroleptic-Induced Tardive Dyskinesia

Neuroleptic-Induced Tardive Dyskinesia Clinical Trial

Official title:

A Randomized Controlled Trial of Risperidone and Olanzapine for the Schizophrenic Patients With Neuroleptic-Induced Tardive Dyskinesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00621998
• Other study ID #: TMH-91-02
• Secondary ID: DOH-890010
• Status: Completed
• Phase: Phase 4
• First received: February 13, 2008
• Last updated: February 13, 2008
• Start date: July 2000
• Est. completion date: June 2004

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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2004
• Est. primary completion date: December 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyskinesias
• Neuroleptic-Induced Tardive Dyskinesia

Intervention

Drug:
• risperidone
0.5-6 mg/day
• olanzapine
2.5-20 mg/day

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	Total scores of AIMS		The change from baseline to study endpoint	No
Secondary	Total scores of BPRS		The change from baseline to study endpoint	No
Secondary	Extrapyramidal syndrome rating scale		The change from baseline to study endpoint	Yes