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

A Randomized Controlled Trial Study of 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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia; Extrapyramidal Syndrome
• Intervention / Treatment: Drug: Risperidone and Olanzapine

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 Type: Interventional
• Enrollment: 70
• Phase: Phase 4

Contacts and Locations

Study Locations

• Taiwan
  • Taoyuan, Taiwan, 330
    • Taoyuan Mental Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Percentage of using concomitant anticholinergic drugs

Secondary Outcome Measures

Outcome Measure
Scores of Rating Scale (Extrapyramidal System Rating Scale, Brief Psychiatric Rating Scale)

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: July 1, 2000
• Study Completion: July 1, 2003

Study Registration Dates

• First Submitted: May 30, 2006
• First Submitted That Met QC Criteria: May 30, 2006
• First Posted (ESTIMATE): May 31, 2006

Study Record Updates

• Last Update Posted (ESTIMATE): May 31, 2006
• Last Update Submitted That Met QC Criteria: May 30, 2006
• Last Verified: February 1, 2000

More Information

Terms related to this study

• Keywords: Schizophrenia, EPS, risperidone, olanzapine
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Schizophrenia Spectrum and Other Psychotic Disorders; Basal Ganglia Diseases; Movement Disorders; Dyskinesias; Schizophrenia; Dystonia; Parkinsonian Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Dopamine Agents; Serotonin Antagonists; Dopamine Antagonists; Olanzapine; Risperidone
• Other Study ID Numbers: DOH-890010; TMH-91-01