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

This study has been completed.
Sponsor:
Collaborator:
Department of Health
Information provided by:
Taoyuan Psychiatric Center, Ministry of Health and Welfare, Executive Yuan, R.O.C. Taiwan
ClinicalTrials.gov Identifier:
NCT00331825
First received: May 30, 2006
Last updated: NA
Last verified: February 2000
History: No changes posted
  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 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 Intervention Phase
Schizophrenia
Extrapyramidal Syndrome
Drug: Risperidone and Olanzapine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
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

Resource links provided by NLM:


Further study details as provided by Taoyuan Psychiatric Center, Ministry of Health and Welfare, Executive Yuan, R.O.C. Taiwan:

Primary Outcome Measures:
  • Percentage of using concomitant anticholinergic drugs

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

Estimated Enrollment: 70
Study Start Date: July 2000
Estimated Study Completion Date: July 2003
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00331825

Locations
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
Study Chair: Hung-Yu Chan, M.D. Taoyuan Psychiatric Center, Ministry of Health and Welfare, Executive Yuan, R.O.C. Taiwan
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00331825     History of Changes
Other Study ID Numbers: DOH-890010, TMH-91-01
Study First Received: May 30, 2006
Last Updated: May 30, 2006
Health Authority: Taiwan: Department of Health

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:
Basal Ganglia Diseases
Parkinsonian Disorders
Schizophrenia
Brain Diseases
Central Nervous System Diseases
Mental Disorders
Movement Disorders
Nervous System Diseases
Schizophrenia and Disorders with Psychotic Features
Antipsychotic Agents
Olanzapine
Risperidone
Antiemetics
Autonomic Agents
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Antagonists
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Antagonists
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014