Background: The treatment of binge eating disorder (BED) is still the object of debate. In the present study, the effectiveness of antidepressant drugs (fluoxetine – FLX – 60 mg/day, fluvoxamine – FLV –300 mg/day), cognitive-behavioural therapy (CBT) and combined treatments (CBT + FLX, CBT + FLV) has been evaluated in a randomized, clinical trial. Results at the end of the active treatment (in the 24th week) and 1-year follow-up outcomes have been evaluated. Methods: One hundred eight (44 M, 64 F) BED patients were randomly assigned to either CBT, FLX (60 mg/day), FLV (300 mg/day), CBT + FLX or CBT + FLV, for 24 weeks. At the beginning (T0), at the end (T1) of treatment and after 1 year (T2), body mass index (BMI) and eating attitude and behaviours (by EDE 12.0D) were assessed. Results: At T1, BMI and EDE scores were significantly reduced in CBT, CBT + FLX and CBT + FLV, but not in the FLX and FLV treatment groups. In the CBT + FLV group, a greater (p < 0.05) reduction of EDE total scores was observed, when compared to CBT + FLX or CBT treatment groups. At T2, BMI was significantly higher than at T1, but still significantly lower than at T0 in the CBT, CBT + FLX and CBT + FLV groups, while EDE scores remained unchanged from T1 in all treatment groups. Conclusions: CBT was more effective than FLX or FLV in the treatment of BED. The addition of FLX to CBT does not seem to provide any clear advantage, while the addition of FLV could enhance the effects of CBT on eating behaviours. Modifications of eating behaviours are maintained at the 1-year follow-up, although the lost weight was partly regained.

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