NCT01401491|CompletedPhase 4
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Sponsor study identifier
interventional
80
1 country
1
Study Start
January 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2010
Actual (reported)Study Completion
December 2010
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2010
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2008
Date type not reportedThis date has not been verified as actual or estimated.
December 2010
Actual (reported)December 2010
Actual (reported)May 19, 2011
Actual (reported)July 25, 2011
Actual (reported)the changes in the psychopathology during the trial
The changes in the scores of psychopathology assessment (the Positive and Negative Syndrome Scale, PANSS)
every 2 weeks
the changes in the metabolic syndrome parameters during the trial
The changes in the metabolic syndrome parameters
every 2 weeks
the changes in the plasma drug levels
every 2 weeks
The changes in insulin levels
every 2 weeks
The changes in the depression severity
every 2 weeks
The changes in the adipokine levels
every 2 weeks
clozapine 100 mg/day plus fluvoxamine 50 mg/day
clozapine 300 mg/day plus placebo
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These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
clozapine plus fluvoxamine
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordTaipei Medical University-Wan Fang Hospital
Taipei, 116, Taiwan
Lu ML, Chen TT, Kuo PH, Hsu CC, Chen CH. Effects of adjunctive fluvoxamine on metabolic parameters and psychopathology in clozapine-treated patients with schizophrenia: A 12-week, randomized, double-blind, placebo-controlled study. Schizophr Res. 2018 Mar;193:126-133. doi: 10.1016/j.schres.2017.06.030. Epub 2017 Jul 6.
Mong-Liang Lu
Taipei Medical University-Wan Fang Hospital
80 participants (actual enrollment reported by the registry).
First Submitted
May 19, 2011
First Posted
July 25, 2011
Study Start
January 2008
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
December 2010
Actual (reported)Study Completion
December 2010
Actual (reported)Last Updated
July 25, 2011
Record last verified: 2011-07
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Source: ClinicalTrials.gov.
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