Fluoxetine in the prevention of depressive recurrences: A double-blind study

Optimal outcomes from depression treatment are long-term recovery and, in t he case of recurrent depression, prevention of new episodes. However, few d ata are available concerning the longterm efficacy of antidepressants in pr ophylactic treatment to prevent recurrences of depression. The efficacy and safety of fluoxetine 20 mg/day was evaluated in reducing the number of dep ressive episodes and in extending the time free of symptoms in patients wit h recurrent unipolar major depression. Patients with recurrent unipolar maj or depression according to DSM-III-R criteria and who responded to 32 weeks of open-label fluoxetine were randomly assigned to receive fluoxetine 20 m g/day (N = 70) or placebo (N = 70) for 48 weeks of double-blind maintenance treatment. Outcome measures were the percentage of recurrences and time to recurrence. Safety assessments included treatment-emergent adverse events, reasons for discontinuation, vital signs, and laboratory measures. Fluoxet ine was associated with a statistically significantly smaller percentage of patients who had a recurrence compared with placebo (20% vs. 40%; chi (2) analysis,p = 0.010). The symptom-free period was significantly longer for p atients treated with fluoxetine versus placebo (295 vs. 192 days; Kaplan-Me ier estimates, log-rank test, p = 0.002). Treatments were well tolerated du ring maintenance treatment. The only statistically significant difference i n adverse events between treatment groups was anxiety, which was more frequ ent in the placebo group (fluoxetine, 12.9% vs. placebo, 30%; chi (2) analy sis, p = 0.013). Two placebo-treated patients and no fluoxetine-treated pat ients were withdrawn because of adverse events. In conclusion, fluoxetine a t 20 mg/day was effective and well tolerated for the prophylactic treatment of recurrent unipolar major depression.