OBJECTIVE: The authors assessed the efficacy of sertraline in the treatment of night eating syndrome. METHOD: Thirty-four outpatients diagnosed with night eating syndrome were randomly assigned to receive either sertraline (N=17) or placebo (N=17) in an 8-week, double-blind, flexible-dose (50-200 mg/day) study. A mixed effects linear regression model was used to analyze change in the primary outcome measure, Clinical Global Impression (CGI) improvement rating. Secondary outcomes included changes in night eating symptoms, the number of nocturnal awakenings and ingestions, total daily caloric intake after the evening meal, CGI severity ratings, quality of life ratings, and weight. RESULTS: Sertraline was associated with significantly greater improvement than placebo. Twelve subjects in the sertraline group (71%) were classified as having responded (CGI improvement rating < or = 2, indicating much or very much improved) versus only three (18%) in the placebo group. There were also significant improvements in night eating symptoms, CGI severity ratings, quality of life ratings, frequency of nocturnal ingestions and awakenings, and caloric intake after the evening meal. Overweight and obese subjects in the sertraline group (N=14) lost a significant amount of weight by week 8 (mean=-2.9 kg, SD=3.8) compared with overweight and obese subjects receiving placebo (N=14) (mean=-0.3 kg, SD=2.7). CONCLUSIONS: In this 8-week trial, sertraline was effective in the treatment of night eating syndrome and was well tolerated.
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