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

- Percentage of using concomitant anticholinergic drugs
- Scores of Rating Scale (Extrapyramidal System Rating Scale, Brief Psychiatric Rating Scale)

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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 |
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

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
Taiwan | |
Taoyuan Mental Hospital | |
Taoyuan, Taiwan, 330 |
Study Chair: | Hung-Yu Chan, M.D. | Taoyuan Psychiatric Center, Ministry of Health and Welfare, Executive Yuan, R.O.C. Taiwan |
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 |
Schizophrenia, EPS, risperidone, olanzapine |
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 |