A Randomized, Placebo-Controlled Trial of Sertraline in the Treatment of Night Eating Syndrome

Background: Night eating syndrome is associated with major health problems that requires treatment.

 

Objective: To determine if sertraline is effective in the treatment of night eating syndrome.

 

Methods:  This was a placebo- controlled, randomized, double blind study.  Patients included were at least 18 years of age who met criteria for night eating syndrome and had a body mass index >18 kg/m².  Exclusion criteria included depression, lifetime diagnosis of bipolar disorder or any psychotic disorder, reported substance abuse or dependence within 6 months, current psychotropic medications, participation in a weight reduction program, current diagnosis of anorexia or bulimia nervosa, or lacked awareness of their night eating episodes. The sertraline and placebo group each contained 17 participants who initially received either 50 mg of the study drug or placebo. Therapy duration was for 8 weeks.  The primary efficacy measure was the CGI improvement rating. The secondary measures included changes in night eating symptoms, the number of nocturnal ingestions and awakenings, total daily calorie intake after the evening meal, CGI severity ratings, quality of life, and weight loss. Intention to treat analysis was used. The power of the study and confidence intervals were not reported.

 

Results: The CGI improvement rating classified 12 of the 17 participants receiving sertraline as having responded and 7 out of these 12 achieved remission of symptoms (p<0.001).  Only 3 of the 17 participants receiving placebo were classified as having responded with 1 of the 3 achieving remission status. Night eating symptoms scores in the sertraline group decreased by 18.1 points (57%) whereas the scores in the placebo group decreased only 5 points (16%) (p<0.0001). The number of nocturnal ingestions decreased 81% in the sertraline group; in the placebo group the number of ingestions decreased 14% (p=0.01). The number of nocturnal awakenings decreased 74% in the sertraline whereas the number of awakenings in the placebo group only decreased 14% (p=0.40). The caloric intake decreased in both the sertraline and placebo groups, a decrease of 68% versus a 29.3% decrease, respectively (p=0.009). The quality of life score in the sertraline group increased from 47.1 at baseline to 54.3 at week 8; the placebo group essentially remained unchanged, 47.6 at baseline to 47.4 at week 8 (p=0.045). Participants overweight in the sertraline group lost 2.9 kg versus 0.3 kg in the placebo group (p=0.06). The differences were significant except the number of awakenings, quality of life, and weight loss.

 

Strengths: This was a well- designed study.  The investigators used well-known rating scales to evaluate outcomes.

 

Weaknesses: The small sample size, short duration, likelihood of unblinding, incidence of type II error, and non- documentation of compliance, confidence intervals, and power were all weaknesses within this study. 

 

Conclusion: Sertraline is more effective than placebo in the treatment of night eating syndrome but it may not be effective in everyone. Long- term studies with large sample sizes need to be conducted to establish efficacy. Since there are no current treatment for night eating syndrome, sertraline would be an appropriate therapy option.

 

O’Reardon J, Allison K, Martino N, Lundgren J, Deo M, Stunkard A. A Randomized, Placebo-Controlled Trial of Sertraline in the Treatment of Night Eating Syndrome. American Journal of Psychiatry. 2006 May; 163(5):893-898

 

Ashley L. Drvar, Pharm.D. Candidate