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Risperidone and Olanzapine for the Schizophrenic Patients With Neuroleptic-Induced Acute Dystonia or Parkinsonism

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ClinicalTrials.gov Identifier: NCT00331825
Recruitment Status : Completed
First Posted : May 31, 2006
Last Update Posted : May 31, 2006
Sponsor:
Collaborator:
Department of Health
Information provided by:
Taoyuan Psychiatric Center, Ministry of Health and Welfare, Executive Yuan, R.O.C. Taiwan

Study Description
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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 incidence of using anticholinergic drugs in schizophrenic patients of Han ethnics with neuroleptic-induced acute dystonia or parkinsonism to test the hypothesis that these two medications have different EPS incidence in EPS intolerant population.

Condition or disease Intervention/treatment Phase
Schizophrenia Extrapyramidal Syndrome Drug: Risperidone and Olanzapine Phase 4

Detailed Description:

Objective: First generation antipsychotics frequently induced extrapyramidal side effects (EPS). Second generation antipsychotics were the choices for EPS intolerant schizophrenic 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 acute dystonia or parkinsonism side effects and observed the incidence of needing concomitant anticholinergic drugs. We also collected the data of average dose of risperidone and olanzapine to help the dosing strategy guidelines for EPS intolerant schizophrenic patients.

Method: This randomized, rater-blind, parallel group, flexible dose study enrolled patients from Taoyuan Mental Hospital from July 2000 to July 2003. Schizophrenia (DSM-IV) patients who met the research criteria of neuroleptic-induced acute dystonia or parkinsonism research criteria of DSM-IV and greater than moderate severity (＞4) of global impression of extrapyramidal syndrome rating scale (ESRS). 70 patients were random assignment to risperidone or olanzapine for 8 weeks. The primary outcome was to compare the incidence of concomitant anticholinergic drugs.

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial Study of Risperidone and Olanzapine for the Schizophrenic Patients With Neuroleptic-Induced Acute Dystonia or Parkinsonism
Study Start Date : July 2000
Study Completion Date : July 2003

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Percentage of using concomitant anticholinergic drugs

Secondary Outcome Measures :
  1. Scores of Rating Scale (Extrapyramidal System Rating Scale, Brief Psychiatric Rating Scale)

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age of 18-65 y/o;
  • Female patients did not have pregnancy plans and must agree to use reliable pregnancy prevention methods if during childbearing age;
  • Meet schizophrenia criteria of DSM-IV;
  • Fulfill DSM-IV neuroleptic-induced acute dystonia or parkinsonism research criteria, the severity of acute dystonia or parkinsonism was greater than moderate degree (＞4) assessed by global impression of Extrapyramidal System Rating Scale (item 43 and 44 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
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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): NCT00331825


Locations
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Taiwan
Taoyuan Mental Hospital
Taoyuan, Taiwan, 330
Sponsors and Collaborators
Taoyuan Psychiatric Center, Ministry of Health and Welfare, Executive Yuan, R.O.C. Taiwan
Department of Health
Investigators
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Study Chair: Hung-Yu Chan, M.D. Taoyuan Psychiatric Center, Ministry of Health and Welfare, Executive Yuan, R.O.C. Taiwan
More Information
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ClinicalTrials.gov Identifier: NCT00331825    
Other Study ID Numbers: DOH-890010
TMH-91-01
First Posted: May 31, 2006    Key Record Dates
Last Update Posted: May 31, 2006
Last Verified: February 2000
Keywords provided by Taoyuan Psychiatric Center, Ministry of Health and Welfare, Executive Yuan, R.O.C. Taiwan:
Schizophrenia, EPS, risperidone, olanzapine
Additional relevant MeSH terms:
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Dystonia
Parkinsonian Disorders
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases
Basal Ganglia Diseases
Brain Diseases
Olanzapine
Risperidone
 Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents