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

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ClinicalTrials.gov Identifier: NCT00621998
Recruitment Status : Completed
First Posted : February 22, 2008
Last Update Posted : February 22, 2008
Sponsor:
Collaborator:
Department of Health
Information provided by:
Taoyuan Psychiatric Center, Ministry of Health and Welfare, Executive Yuan, R.O.C. Taiwan

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.

Condition or disease Intervention/treatment Phase
Neuroleptic-Induced Tardive Dyskinesia Drug: risperidone Drug: olanzapine Phase 4

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  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Risperidone and Olanzapine for the Schizophrenic Patients With Neuroleptic-Induced Tardive Dyskinesia
Study Start Date : July 2000
Primary Completion Date : December 2003
Study Completion Date : June 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. Total scores of AIMS [ Time Frame: The change from baseline to study endpoint ]

Secondary Outcome Measures :
  1. Total scores of BPRS [ Time Frame: The change from baseline to study endpoint ]
  2. Extrapyramidal syndrome rating scale [ Time Frame: The change from baseline to study endpoint ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00621998


Locations
Taiwan
Taoyuan Mental Hospital
Taoyuan, Taiwan, 33058
Sponsors and Collaborators
Taoyuan Psychiatric Center, Ministry of Health and Welfare, Executive Yuan, R.O.C. Taiwan
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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hung-Yu Chan/ Attending Psychiatry and Director of General Psychiatry, Taoyuan Mental Hospital
ClinicalTrials.gov Identifier: NCT00621998     History of Changes
Other Study ID Numbers: TMH-91-02
DOH-890010
First Posted: February 22, 2008    Key Record Dates
Last Update Posted: February 22, 2008
Last Verified: February 2000

Keywords provided by Taoyuan Psychiatric Center, Ministry of Health and Welfare, Executive Yuan, R.O.C. Taiwan:
Risperidone
Olanzapine
Tardive dyskinesia

Additional relevant MeSH terms:
Dyskinesias
Tardive Dyskinesia
Movement Disorders
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Dyskinesia, Drug-Induced
Risperidone
Olanzapine
Antipsychotic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators