NCT00331825

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for phase_4 schizophrenia

Timeline
Completed

Started Jul 2000

Typical duration for phase_4 schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2000

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2003

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

May 30, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 31, 2006

Completed
Last Updated

May 31, 2006

Status Verified

February 1, 2000

First QC Date

May 30, 2006

Last Update Submit

May 30, 2006

Conditions

SchizophreniaExtrapyramidal Syndrome

Keywords

Schizophrenia, EPS, risperidone, olanzapine

Outcome Measures

Primary Outcomes (1)

  • Percentage of using concomitant anticholinergic drugs

Secondary Outcomes (1)

  • Scores of Rating Scale (Extrapyramidal System Rating Scale, Brief Psychiatric Rating Scale)

Interventions

Risperidone and OlanzapineDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taoyuan Mental Hospital

Taoyuan District, 330, Taiwan

Location

MeSH Terms

Conditions

SchizophreniaBasal Ganglia Diseases

Interventions

RisperidoneOlanzapine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

PyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Hung-Yu Chan, M.D.

    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
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

May 30, 2006

First Posted

May 31, 2006

Study Start

July 1, 2000

Study Completion

July 1, 2003

Last Updated

May 31, 2006

Record last verified: 2000-02

Locations

TW(1)