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For adults with binge eating disorder (BED), treatment with the long-acting dopamine/norepinephrine reuptake inhibitor dasotraline is effective for weight reduction and improvement in binge-related compulsions and obsessive thoughts, according to study results presented at Psych Congress 2019, held October 3 to 6 in San Diego, California.
Having previously found that dasotraline is effective in the treatment of BED, researchers examined the medication’s effects on body weight in patients with overweight/obesity,1 as well as its effects on obsessions and compulsions related to binge eating.2
Patients aged 18 to 55 years were randomly assigned to receive once-daily doses of dasotraline (4 mg, 6 mg, or 8 mg) or placebo for 12 weeks. Dasotraline dose adjustments were made at the discretion of the investigators and increased to 6 mg/d by week 4 for all patients included in the study.
The primary end point was mean change in binge eating days per week. The Yale-Brown Obsessive-Compulsive Scale Modified for Binge-Eating was used to assess the severity of obsessive thoughts and compulsive behaviors. Mixed model for repeated measures analyses were used to evaluate these end points as well as change in mean body mass index (BMI) and weight from baseline.
In total, 317 patients were included in the safety population and 315 were included in the intention-to-treat population; 155 received dasotraline (mean age, 38.7 years; 87.7% women) and 160 received placebo (mean age, 37.8 years; 19.4% women). According to BMI at baseline, 5.7% of patients were normal weight, 18.3% were overweight, and 76% were obese (class 1: 24.9%; class 2: 29.3%; class 3: 21.8%).1
Mean daily dose of dasotraline was 5.5 mg/d. Compared with the placebo group, patients who received dasotraline had a significant reduction in binge eating days per week (-2.75 vs -3.74 days, respectively; P <.0001).
This reduction in binge eating was associated with significant mean changes in weight (-5.7 kg) and BMI (-2.0 kg/m2) in the dasotraline group by week 12. Patients with obesity (class 1-3 combined) who received dasotraline had a mean change in weight from baseline to week 12 of -6.2 kg compared with a mean change of +0.3 kg in the placebo group.1
With regard to binge-related compulsions and obsessive thoughts, individuals who had a Yale-Brown Obsessive-Compulsive Scale Modified for Binge-Eating score ≤12 after 12 weeks were categorized as having symptomatic remission. All 10 items measured by the score were significantly improved with dasotraline (P <.001 for all comparisons with placebo) and change in total score was significantly greater with dasotraline vs placebo (-17.05 vs -9.88, respectively; P <.0001).
In patients who achieved a Binge Eating Clinical Global Impression-Severity score of 1 (normal; 52.3%), mean end point score for obsessive thoughts and compulsions was 0.5, indicating clinical remission in these measures for the majority of patients.2
The most frequently reported weight-related adverse event was decreased appetite, which was more common in the dasotraline vs placebo group.1
Taken together, these secondary analyses of dasotraline found the medication to be associated with meaningful reductions in binge eating days per week, weight, and BED-related compulsions and obsessions after 12 weeks of treatment.
For more coverage of Psych Congress 2019, click here.
Disclosure: This research was supported by Sunovion Pharmaceuticals. Please see the original references for a full list of authors’ disclosures.
References
1. Citrome L, Goldman R, Mandel M, et al. Effect of dasotraline on body weight in patients with binge-eating disorder. Presented at: Psych Congress 2019; October 3-6, 2019; San Diego, CA. Poster 143.
2. Citrome L, Goldman R, Tsai J, Deng L, Grinnell T, Pikalov A. Dasotraline for treatment of adults with binge-eating disorder: effect on binge-related obsessions and compulsions. Presented at: Psych Congress 2019; October 3-6, 2019; San Diego, CA. Poster 240.
