Objective: To evaluate the efficacy of dasotraline in the treatment of secondary behavioral and psychological outcomes in patients with Binge-eating disorder (BED).
Methods: Patients with BED (N=317) were randomized, double-blind, to 12 weeks of treatment with flexible doses of dasotraline (4, 6, and 8 mg/d), or placebo. The primary efficacy measure was number of binge eating (BE) days/week. Secondary outcomes included the Yale-Brown Obsessive-Compulsive Scale Modified for Binge Eating (Y-BOCS-BE); and the Eating Disorder Examination Questionnaire Brief Version (EDE-Q7), which consists of a global score, and 3 subscale scores (dietary restraint, shape concern, and weight concern).
Results: Mean reduction from baseline in number of BE days/week was significantly greater for dasotraline vs. placebo at week 12 (-3.74 vs. -2.75; P<0.0001). Mean endpoint change was significantly greater for the dasotraline vs. placebo on the Y-BOCS-BE total score (-17.05 vs. -9.88; P<0.0001), the obsession subscale score (-8.32 vs. -4.58; P<0.0001), and the compulsion subscale score (-8.69 vs. -5.35; P<0.0001). Mean endpoint change was also significantly greater for dasotraline vs. placebo on the EDE-Q7 global score (-0.85 vs. -0.23; P<0.001), and dietary restraint (-0.55 vs. +0.15; P<0.001), shape concern (-0.93 vs. -0.43; P=0.011), and weight concern (-1.03 vs. -0.44; P=0.003) subscale scores.
Conclusions: In this 12-week study of BED patients, treatment with dasotraline (4-8 mg/d) was associated with significant improvement in behavioral and psychological outcomes, including measures of obsessions and compulsions, and weight and shape concerns associated with BED, and intensity of attempts to restrict food intake.