Efficacy and Safety of Dasotraline in Adults With Binge-Eating Disorder: A Randomized, Placebo-Controlled, Flexible-Dose Clinical Trial.

Abstract

OBJECTIVE:

Binge-eating disorder (BED) is the most prevalent eating disorder; however, few evidence-based treatments are available. The aim of this study was to evaluate the efficacy and safety of dasotraline, a novel dopamine and norepinephrine reuptake inhibitor, in adults with BED.

METHODS:

Patients with a DSM-5 diagnosis of BED (intent-to-treat sample, N = 315) were randomized to 12 weeks of double-blind treatment with once-daily, flexible doses (4, 6, or 8 mg/d) of dasotraline or placebo. Primary endpoint was change in diary-based assessment of number of binge-eating days per week at week 12. Key secondary endpoints included changes from baseline in Clinical Global Impressions-Severity of Illness scale (CGI-S) and Yale-Brown Obsessive Compulsive Scale Modified for Binge-Eating (YBOCS-BE) and percentage of subjects with cessation of binge eating in the final 4 weeks.

RESULTS:

Treatment with dasotraline was associated with a significantly greater reduction in binge-eating days per week at study endpoint (vs placebo; least squares mean [SE] difference score, -0.99 [0.17]; P < .0001; effect size [ES], 0.74). Significant endpoint improvement was observed for the 3 key secondary measures, CGI-S (P < .0001; ES, 0.95), YBOCS-BE (P < .0001; ES, 0.96), and 4-week cessation of binge eating (46.5% vs 20.6%; P < .0001). The most common adverse events in the dasotraline vs placebo groups were insomnia (44.6% vs 8.1%), dry mouth (27.4% vs 5.0%), decreased appetite (19.7% vs 6.9%), and anxiety (17.8% vs 2.5%). Discontinuation due to adverse events occurred in 11.3% of patients on dasotraline vs 2.5% on placebo.

CONCLUSIONS:

The results of this placebo-controlled, double-blind study found dasotraline to be an efficacious, safe, and generally well-tolerated treatment for BED.

TRIAL REGISTRATION:

ClinicalTrials.gov identifier: NCT02564588.

• Authors: Susan L McElroy, James I Hudson, Carlos M Grilo, Anna I Guerdjikova, Ling Deng, Kenneth S Koblan, Robert Goldman, Bradford Navia, Seth Hopkins, Antony Loebel
• Journal: The Journal of clinical psychiatry (J Clin Psychiatry) Vol. 81 Issue 5 (09 08 2020) ISSN: 1555-2101 [Electronic] United States
• PMID: 32926604 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © Copyright 2020 Physicians Postgraduate Press, Inc.

Chemical References

• Dopamine Antagonists
• 4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydronaphthalen-1-amine
• 1-Naphthylamine

Topics

• 1-Naphthylamine (administration & dosage, adverse effects, analogs & derivatives, therapeutic use)
• Adult
• Binge-Eating Disorder (drug therapy)
• Dopamine Antagonists (administration & dosage, adverse effects, therapeutic use)
• Double-Blind Method
• Female
• Humans
• Male
• Treatment Outcome