Clinical trial NCT00331825: Risperidone and Olanzapine for the Schizophrenic Patients With Neuroleptic-Induced Acute Dystonia or Parkinsonism
Official title: A Randomized Controlled Trial Study of Risperidone and Olanzapine for the Schizophrenic Patients With Neuroleptic-Induced Acute Dystonia or Parkinsonism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Extrapyramidal Syndrome
Keywords: Schizophrenia, EPS, risperidone, olanzapine
Lead sponsor: Taoyuan Psychiatric Center, Ministry of Health and Welfare, Executive Yuan, R.O.C. Taiwan
Sponsor class: OTHER_GOV
Collaborators: name: Department of Health
First posted: 2006-05-31
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Percentage of using concomitant anticholinergic drugs
Secondary outcomes:
measure: Scores of Rating Scale (Extrapyramidal System Rating Scale, Brief Psychiatric Rating Scale)
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Taoyuan Mental Hospital
Study officials:
affiliation: Taoyuan Psychiatric Center, Ministry of Health and Welfare, Executive Yuan, R.O.C. Taiwan
name: Hung-Yu Chan, M.D.
role: STUDY_CHAIR
References: