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The first trial to assess the role of fluvoxamine in the treatment of depression dates back to 1976. We identified 38 randomized, single- or double-blind studies conducted since then to test the antidepressant efficacy of fluvoxamine against placebo, SSRIs (sertraline, fluoxetine, citalopram, and paroxetine), serotonin-norepinephrine reuptake inhibitors (SNRIs; venlafaxine and milnacipran), tricyclic antidepressants (clomipramine, imipramine, desipramine, amitriptyline, and nortriptyline), tetracyclic antidepressants (mianserin and maprotiline), and a reversible inhibitor of monoamine oxidase (moclobemide). These trials varied widely in design, including the diagnostic and inclusion criteria utilized, the requirement for a washout period before initiation of study drug, and the way treatment response was defined. However, taken together, these studies support the efficacy and safety of fluvoxamine in the treatment of mild, moderate, and severe depression—including psychotic depression—across all age groups and in both inpatient and outpatient settings (Fukuchi and Kanemoto 2002; Haffmans et al. 1996; Kiev and Feiger 1997; Otsubo et al. 2005; Rapaport et al. 1996; Rossini et al. 2005; Ware 1997; Zanardi et al. 2000; Zohar et al. 2003). Among all studies, none showed fluvoxamine to be inferior in efficacy to another active comparator when a priori response criteria were applied. Study durations ranged from 4 to 7 weeks, and dosages ranged from 50 to 300 mg/day. Furthermore, the benefits from fluvoxamine seem to be sustained over the long term. In a double-blind, placebo-controlled study assessing the efficacy of fluvoxamine continuation treatment, fluvoxamine at 100 mg/day was significantly superior to placebo in preventing symptom recurrence over the 1-year maintenance period (Terra and Montgomery 1998).

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