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Completed

NCT Number: NCT00331825

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Taoyuan Mental Hospital

Taoyuan, 330, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Risperidone and Olanzapine

Drug

Primary outcomes

  1. Percentage of using concomitant anticholinergic drugs

Secondary outcomes

  1. Scores of Rating Scale (Extrapyramidal System Rating Scale, Brief Psychiatric Rating Scale)

Sponsors and collaborators

Lead sponsor

Taoyuan Psychiatric Center, Ministry of Health and Welfare, Executive Yuan, R.O.C. Taiwan

Other Gov

Collaborators

  • Department of Health

Registry information

Official study title

A Randomized Controlled Trial Study of Risperidone and Olanzapine for the Schizophrenic Patients With Neuroleptic-Induced Acute Dystonia or Parkinsonism

Important dates

Study start
2000
Study completion
2003
First posted
May 31, 2006
Registry last updated
May 31, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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