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

Sponsors and Collaborators:	Taoyuan Mental Hospital Department of Health
Information provided by:	Taoyuan Mental Hospital
ClinicalTrials.gov Identifier:	NCT00621998

Purpose

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.

Condition	Intervention	Phase
Neuroleptic-Induced Tardive Dyskinesia	Drug: risperidone Drug: olanzapine	Phase IV

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia

Drug Information available for: Risperidone Olanzapine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Randomized Controlled Trial of Risperidone and Olanzapine for the Schizophrenic Patients With Neuroleptic-Induced Tardive Dyskinesia

Further study details as provided by Taoyuan Mental Hospital:

Primary Outcome Measures:

Total scores of AIMS [ Time Frame: The change from baseline to study endpoint ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Total scores of BPRS [ Time Frame: The change from baseline to study endpoint ] [ Designated as safety issue: No ]
Extrapyramidal syndrome rating scale [ Time Frame: The change from baseline to study endpoint ] [ Designated as safety issue: Yes ]

Enrollment:	60
Study Start Date:	July 2000
Study Completion Date:	June 2004
Primary Completion Date:	December 2003 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Flexible dose of olanzapine	Drug: olanzapine 2.5-20 mg/day
2: Active Comparator Flexible dose of risperidone	Drug: risperidone 0.5-6 mg/day

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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00621998

Locations

Taiwan
Taoyuan Mental Hospital
Taoyuan, Taiwan, 33058

Sponsors and Collaborators

Taoyuan Mental Hospital

Department of Health

Investigators

Study Chair:

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

Taoyuan Mental Hospital

More Information

Responsible Party:	Taoyuan Mental Hospital ( Hung-Yu Chan/ Attending Psychiatry and Director of General Psychiatry )
Study ID Numbers:	TMH-91-02, DOH-890010
Study First Received:	February 13, 2008
Last Updated:	February 13, 2008
ClinicalTrials.gov Identifier:	NCT00621998
Health Authority:	Taiwan: Department of Health

Keywords provided by Taoyuan Mental Hospital:

Risperidone
Olanzapine
Tardive dyskinesia

Study placed in the following topic categories:

Signs and Symptoms
Dopamine
Movement Disorders
Risperidone
Olanzapine
Neurologic Manifestations

Central Nervous System Diseases
Dyskinesias
Serotonin
Tardive dyskinesia
Oral facial dyskinesia

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Physiological Effects of Drugs
Gastrointestinal Agents
Psychotropic Drugs
Antiemetics
Central Nervous System Depressants
Dopamine Antagonists

Antipsychotic Agents
Serotonin Uptake Inhibitors
Pharmacologic Actions
Serotonin Antagonists
Serotonin Agents
Autonomic Agents
Therapeutic Uses
Dopamine Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009