Risperidone and Olanzapine for the Schizophrenic Patients With Neuroleptic-Induced Tardive Dyskinesia

This study has been completed.
Sponsor:
Collaborator:
Department of Health
Information provided by:
Taoyuan Mental Hospital
ClinicalTrials.gov Identifier:
NCT00621998
First received: February 13, 2008
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 effects of these 2 drugs in schizophrenic spectrum patients of Han ethnics with neuroleptic-induced tardive dyskinesia to test the hypothesis that these two medications have different effects in improving tardive dyskinesia.


Condition Intervention Phase
Neuroleptic-Induced Tardive Dyskinesia
Drug: risperidone
Drug: olanzapine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Risperidone and Olanzapine for the Schizophrenic Patients With Neuroleptic-Induced Tardive Dyskinesia

Resource links provided by NLM:


Further study details as provided by Taoyuan Mental Hospital:

Primary Outcome Measures:
  • Total scores of AIMS [ Time Frame: The change from baseline to study endpoint ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Total scores of BPRS [ Time Frame: The change from baseline to study endpoint ] [ Designated as safety issue: No ]
  • Extrapyramidal syndrome rating scale [ Time Frame: The change from baseline to study endpoint ] [ Designated as safety issue: Yes ]

Enrollment: 60
Study Start Date: July 2000
Study Completion Date: June 2004
Primary Completion Date: December 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Flexible dose of olanzapine
Drug: olanzapine
2.5-20 mg/day
Active Comparator: 2
Flexible dose of risperidone
Drug: risperidone
0.5-6 mg/day

Detailed Description:

Objective: First generation antipsychotics would induce tardive dyskinesia in some schizophrenic patients. Second generation antipsychotics were the choices for these 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 neuroleptic-induced tardive dyskinesia to see their effects in improving tardive dyskinesia. We also collected the data of average dose of risperidone and olanzapine to help the dosing strategy guidelines for the schizophrenic patients with neuroleptic-induced tardive dyskinesia.

Method: This randomized, rater-blind, parallel group, flexible dose study enrolled patients from Taoyuan Mental Hospital from July 2000 to December 2003. Schizophrenia, schizophreniform or schizoaffective disorder (DSM-IV) patients who met the research criteria of neuroleptic-induced tardive dyskinesia research criteria of DSM-IV and no less than moderate severity (> or =4) of global impression of extrapyramidal syndrome rating scale (ESRS). 60 patients were random assignment to risperidone or olanzapine for 24 weeks. The primary outcome was to compare the change of total scores of abnormal involuntary movement scale from baseline to study endpoint.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age of 18-70 y/o
  • Female patients did not have pregnancy plans and must agree to use reliable pregnancy prevention methods if during childbearing age
  • Meet schizophrenia, schizophreniform or schizoaffective disorder criteria of DSM-IV
  • Fulfill DSM-IV neuroleptic-induced tardive dyskinesia research criteria, the severity of tardive dyskinesia was no less than moderate degree (> or =4) assessed by global impression of Extrapyramidal System Rating Scale (item 42 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: NCT00621998

Locations
Taiwan
Taoyuan Mental Hospital
Taoyuan, Taiwan, 33058
Sponsors and Collaborators
Taoyuan Mental Hospital
Department of Health
Investigators
Study Chair: Hung-Yu Chan, M.D., M.S. Taoyuan Mental Hospital
  More Information

No publications provided by Taoyuan Mental Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hung-Yu Chan/ Attending Psychiatry and Director of General Psychiatry, Taoyuan Mental Hospital
ClinicalTrials.gov Identifier: NCT00621998     History of Changes
Other Study ID Numbers: TMH-91-02, DOH-890010
Study First Received: February 13, 2008
Last Updated: February 13, 2008
Health Authority: Taiwan: Department of Health

Keywords provided by Taoyuan Mental Hospital:
Risperidone
Olanzapine
Tardive dyskinesia

Additional relevant MeSH terms:
Dyskinesias
Movement Disorders
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Antipsychotic Agents
Risperidone
Olanzapine
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Dopamine Antagonists
Dopamine Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on July 23, 2014