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

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

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.

Study Overview

• Status: Completed
• Conditions: Neuroleptic-Induced Tardive Dyskinesia
• Intervention / Treatment: Drug: olanzapine; Drug: risperidone

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Taiwan
  • Taoyuan, Taiwan, 33058
    • Taoyuan Mental Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Flexible dose of olanzapine	Drug: olanzapine; 2.5-20 mg/day
Active Comparator: 2; Flexible dose of risperidone	Drug: risperidone; 0.5-6 mg/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Total scores of AIMS	The change from baseline to study endpoint

Secondary Outcome Measures

Outcome Measure	Time Frame
Total scores of BPRS	The change from baseline to study endpoint
Extrapyramidal syndrome rating scale	The change from baseline to study endpoint

Collaborators and Investigators

• Sponsor: Taoyuan Psychiatric Center, Ministry of Health and Welfare, Executive Yuan, R.O.C. Taiwan
• Collaborators: Department of Health
• Investigators: Study Chair: Hung-Yu Chan, M.D., M.S., Taoyuan Psychiatric Center, Ministry of Health and Welfare, Executive Yuan, R.O.C. Taiwan

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2000
• Primary Completion (Actual): December 1, 2003
• Study Completion (Actual): June 1, 2004

Study Registration Dates

• First Submitted: February 13, 2008
• First Submitted That Met QC Criteria: February 13, 2008
• First Posted (Estimate): February 22, 2008

Study Record Updates

• Last Update Posted (Estimate): February 22, 2008
• Last Update Submitted That Met QC Criteria: February 13, 2008
• Last Verified: February 1, 2000

More Information

Terms related to this study

• Keywords: Risperidone; Tardive dyskinesia; Olanzapine
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Movement Disorders; Dyskinesia, Drug-Induced; Dyskinesias; Tardive Dyskinesia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Dopamine Agents; Serotonin Antagonists; Dopamine Antagonists; Olanzapine; Risperidone
• Other Study ID Numbers: TMH-91-02; DOH-890010