Fluvoxamine maleate is used in the treatment of obsessive-compulsive disorder in adults and pediatric patients 8 years of age and older when obsessions or compulsions cause marked distress, are time-consuming, or interfere substantially with social or occupational functioning.
Efficacy of immediate-release fluvoxamine maleate tablets for the acute management of obsessive-compulsive disorder in adults has principally been established by 2 multicenter, placebo-controlled studies of 10 weeks' duration in outpatient settings. Patients enrolled in these studies had moderate to severe obsessive-compulsive disorder. Immediate-release fluvoxamine maleate was titrated to a total daily dosage of 150 mg daily over the first 2 weeks, and then the dosage was adjusted within the range of 100-300 mg daily (given in 2 divided doses) based on patient response and tolerability. In these and a limited number of other clinical studies in patients with obsessive-compulsive disorder, fluvoxamine was found to be more effective than placebo in reducing the severity of symptoms associated with this disorder. In the studies used to establish efficacy, a positive clinical response (much or very much improved on the Clinical Global Impressions scale) occurred in 43 or 12% of patients receiving fluvoxamine or placebo, respectively. No age- or gender-related differences in efficacy were noted in these studies.
Efficacy of extended-release fluvoxamine maleate capsules for the acute treatment of obsessive-compulsive disorder was demonstrated in a multicenter, placebo-controlled study of 12 weeks' duration in adult outpatients with moderate to severe obsessive-compulsive disorder. Dosage was titrated in 50-mg increments over the first 6 weeks based on response and tolerability from an initial dosage of 100 mg daily to a dosage ranging from 100-300 mg daily. Patients receiving extended-release fluvoxamine demonstrated greater improvement on the Yale-Brown Obsessive-Compulsive Scale from baseline to week 12 compared with patients receiving placebo. The mean dosage of extended-release fluvoxamine maleate was 261 mg daily at the end of the study. No age- or gender-related differences in efficacy were observed in this study.
Results from a limited number of comparative studies suggest that fluvoxamine immediate-release tablets are as effective as clomipramine in the management of obsessive-compulsive disorder. Like fluoxetine and clomipramine, fluvoxamine reduces but does not eliminate obsessions and compulsions. Therapeutic response to fluvoxamine in patients with obsessive-compulsive disorder generally is evident within 2-3 weeks, but may not be maximal until several months after beginning therapy with the drug.
Efficacy of fluvoxamine for long-term use was established in a clinical trial in adults receiving immediate-release fluvoxamine tablets. In addition, the drug reportedly has been used in some patients for prolonged periods (i.e., for up to 8 years) without apparent loss of clinical effect. If fluvoxamine is used for extended periods, the need for continued therapy should be reassessed periodically.
As with other antidepressants, the possibility that fluvoxamine may precipitate hypomanic or manic attacks in patients with bipolar or other major affective disorders should be considered.
Fluvoxamine has been used in the treatment of bulimia nervosa. In one double-blind, placebo-controlled study in patients with bulimia nervosa, maintenance therapy with fluvoxamine following an inpatient treatment program resulted in an attenuated relapse rate compared with treatment with placebo. For further information on use of antidepressants in the treatment of bulimia nervosa,