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

NCT ID: NCT00621998

Last Updated: 2008-02-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-07-31
• Study Completion Date: 2004-06-30

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 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.

Detailed 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.

Conditions

Neuroleptic-Induced Tardive Dyskinesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1

Flexible dose of olanzapine

Group Type: EXPERIMENTAL

olanzapine

Intervention Type: DRUG

2.5-20 mg/day

2

Flexible dose of risperidone

Group Type: ACTIVE_COMPARATOR

risperidone

Intervention Type: DRUG

0.5-6 mg/day

Interventions

risperidone

0.5-6 mg/day

Intervention Type: DRUG

olanzapine

2.5-20 mg/day

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Department of Health

AMBIG

Sponsor Role: collaborator

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

OTHER_GOV

Sponsor Role: lead

Responsible Party

Taoyuan Mental Hospital

Principal Investigators

Hung-Yu Chan, M.D., M.S.

Role: STUDY_CHAIR

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

Locations

Taoyuan Mental Hospital

Taoyuan District, , Taiwan

Countries

Taiwan

References

Chan HY, Chiang SC, Chang CJ, Gau SS, Chen JJ, Chen CH, Hwu HG, Lai MS. A randomized controlled trial of risperidone and olanzapine for schizophrenic patients with neuroleptic-induced tardive dyskinesia. J Clin Psychiatry. 2010 Sep;71(9):1226-33. doi: 10.4088/jcp.09m05155yel.

Reference Type: DERIVED

PMID: 20441726 (View on PubMed)

Other Identifiers

DOH-890010

Identifier Type: -

Identifier Source: secondary_id

TMH-91-02

Identifier Type: -

Identifier Source: org_study_id