Treatment Strategy for Refractory Schizophrenia: Drug Interaction Between Clozapine and Fluvoxamine

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

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 and consequently did not tolerate this medication. There are patients who do not respond to clozapine, and the need to treat these severely ill patients frequently compels clinicians to adopt therapeutic innovations that lack a sound empirical basis. One strategy is the combination of various other somatic treatments with clozapine.

Recently, the investigators conduct a preliminary open trial to evaluate the safety and efficacy of fluvoxamine coadministration with clozapine in refractory schizophrenic patients. The combined treatment is well tolerated, and clinical improvement is observed in our patients. And the concomitant fluvoxamine could attenuate the clozapine-induced weight gain and metabolic disturbance. However, the effects of fluvoxamine on the safety and therapeutic efficacy of clozapine need to be further clarified in double-blind study.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Taipei Medical University Hospital
• Collaborator: National Health Research Institutes, Taiwan
• Treatments: Clozapine; Fluvoxamine

Criteria

Inclusion Criteria:

1. Inpatients meet the DSM-IV criteria for schizophrenia.

2. 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.

3. Age 18-60 years.

4. Males or females.

5. Total PANSS score >60

6. Good physical health determined by complete physical examination, laboratory tests, and EKG.

7. Capacity and willingness to give written informed consent.

Exclusion Criteria:

1. History of illicit substance abuse or dependence

2. History of clozapine intolerance (such as clinically significant leukopenia or agranulocytosis).

3. Patients with WBC count less than 3500/mm3 or ANC count less than 2000/mm3will not be included.

4. Any depot neuroleptics within 30 days before the day of randomization.

5. 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.