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

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

Study Description

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

• 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

Arms and Interventions

Outcome Measures

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

• 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

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

• ClinicalTrials.gov Identifier: NCT00331825
• Other Study ID Numbers: DOH-890010; TMH-91-01
• First Posted: May 31, 2006
• 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:

Dystonia; Parkinsonian Disorders; Schizophrenia; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Dyskinesias; Neurologic Manifestations; Nervous System Diseases; 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; Serotonin Uptake Inhibitors