A DOUBLE-BLIND-STUDY OF LONG-TERM TREATMENT WITH SERTRALINE OR FLUVOXAMINE FOR PREVENTION OF HIGHLY RECURRENT UNIPOLAR DEPRESSION

Background: We evaluated and compared the efficacy and safety of sertr aline and fluvoxamine in a randomized, double-blind, parallel-group st udy during a follow-up of 24 months. Method: Sixty-four patients with recurrent, unipolar depression (DSM-IV criteria) who had at least one depressive episode during the 18 months preceding the index episode we re accepted into the trial. Patients were randomly assigned to one of the two long-term treatment groups and evaluated monthly by trained ps ychiatrists, blinded to treatment option, on the basis of the Hamilton Rating Scale for Depression. Results: All patients completed the 24-m onth follow-up period. Sertraline and fluvoxamine showed an equal effi cacy in preventing new recurrences. In fact, there was no significant difference in survival rates between the two medication groups: 7 sert raline-treated patients (21.9%) and 6 fluvoxamine-treated patients (18 .7%) had a single new recurrence (z=0.14; p=.88). Moreover, recurrence observed during maintenance therapies was less severe and/or of short er duration than index episodes. Conclusion: Long-term treatment with sertraline or fluvoxamine has been shown to be effective for preventio n of highly recurrent unipolar depression. The high tolerability of th ese compounds, together with their prophylactic effectiveness, has an important role in improving the quality of life of these patients.