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

NCT01401491 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2011-07-25

No results posted yet for this study

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.

Conditions

Interventions

DRUG

clozapine plus fluvoxamine

clozapine 100 mg/day plus fluvoxamine 50 mg/day

DRUG

clozapine plus placebo

clozapine 300 mg/day plus placebo

Sponsors & Collaborators

  • National Health Research Institutes, Taiwan

    collaborator OTHER

  • Taipei Medical University Hospital

    lead OTHER

Principal Investigators

  • Mong-Liang Lu · Taipei Medical University-Wan Fang Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01401491 on ClinicalTrials.gov