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

NCT00621998 | Completed Phase 4 DMC

• 2 other identifiers: TMH-91-02DOH-890010
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Neuroleptic-Induced Tardive Dyskinesia

Keywords

Risperidone; Olanzapine; Tardive dyskinesia

Outcome Measures

Primary Outcomes (1)

• Total scores of AIMS

  The change from baseline to study endpoint

Secondary Outcomes (2)

• Total scores of BPRS

  The change from baseline to study endpoint

• Extrapyramidal syndrome rating scale

  The change from baseline to study endpoint

Study Arms (2)

1

EXPERIMENTAL

Flexible dose of olanzapine

Drug: olanzapine

2

ACTIVE COMPARATOR

Flexible dose of risperidone

Drug: risperidone

Interventions

risperidone DRUG

0.5-6 mg/day

2

olanzapine DRUG

2.5-20 mg/day

1

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taoyuan Psychiatric Center, Ministry of Health and Welfare, Executive Yuan, R.O.C. Taiwan: lead
• Department of Health: collaborator

Study Sites (1)

Taoyuan Mental Hospital

Taoyuan District, 33058, Taiwan

Location

Related Publications (1)

• Chan HY, Chiang SC, Chang CJ, Gau SS, Chen JJ, Chen CH, Hwu HG, Lai MS. A randomized controlled trial of risperidone and olanzapine for schizophrenic patients with neuroleptic-induced tardive dyskinesia. J Clin Psychiatry. 2010 Sep;71(9):1226-33. doi: 10.4088/jcp.09m05155yel.

  PMID: 20441726 DERIVED

MeSH Terms

Conditions

Tardive Dyskinesia

Interventions

Risperidone; Olanzapine

Condition Hierarchy (Ancestors)

Dyskinesia, Drug-Induced; Dyskinesias; Movement Disorders; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Hung-Yu Chan, M.D., M.S.

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: February 13, 2008
• First Posted: February 22, 2008
• Study Start: July 1, 2000
• Primary Completion: December 1, 2003
• Study Completion: June 1, 2004
• Last Updated: February 22, 2008

Record last verified: 2000-02

Locations

TW (1)