Status:
COMPLETED
Treatment Strategy for Refractory Schizophrenia: Drug Interaction Between Clozapine and Fluvoxamine
Lead Sponsor:
Taipei Medical University Hospital
Collaborating Sponsors:
National Health Research Institutes, Taiwan
Conditions:
Schizophrenia
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
Brief Summary
Clozapine has been virtually the only psychopharmacological choice in patients with schizophrenia who either did not response to typical neuroleptics or experienced severe extrapyramidal side effects ...
Detailed Description
Background Schizophrenia is one of the most severe mental illnesses. The prevalence of schizophrenia has been variously reported as ranging from 1 to 1.5 percent. More than 50% of patients can be desc...
Eligibility Criteria
Inclusion
- Inpatients meet the DSM-IV criteria for schizophrenia.
- Treatment refractoriness: Failed to respond to at least two typical neuroleptics at dosage equivalent to or greater than 1000 mg/day of chlorpromazine for a period of at least six weeks.
- Age 18-60 years.
- Males or females.
- Total PANSS score \>60
- Good physical health determined by complete physical examination, laboratory tests, and EKG.
- Capacity and willingness to give written informed consent.
Exclusion
- History of illicit substance abuse or dependence
- History of clozapine intolerance (such as clinically significant leukopenia or agranulocytosis).
- Patients with WBC count less than 3500/mm3 or ANC count less than 2000/mm3will not be included.
- Any depot neuroleptics within 30 days before the day of randomization.
- Epilepsy, active hepatitis, HIV positivity, or current myeloproliferative disorder. Other medical illnesses may necessitate subjects' exclusion after evaluation of individual cases by the principal investigator and other staffs. Clinical judgment will be used.
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT01401491
Start Date
January 1 2008
End Date
December 1 2010
Last Update
July 25 2011
Active Locations (1)
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1
Taipei Medical University-Wan Fang Hospital
Taipei, Taiwan, 116