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Dasotraline for the treatment of attention-deficit/hyperactivity disorder: A randomized, double-blind, placebo-controlled, proof-of-concept trial in adults

Publication ,  Journal Article
Koblan, KS; Hopkins, SC; Sarma, K; Jin, F; Goldman, R; Kollins, SH; Loebel, A
Published in: Neuropsychopharmacology
2015

© 2015 American College of Neuropsychopharmacology.Attention-deficit/hyperactivity disorder (ADHD) is a neurodevelopmental disorder characterized by symptoms of inattention, hyperactivity, and impulsivity associated with clinically significant impairment in functioning. ADHD has an early onset, but frequently persists, with a prevalence estimate of 4% in adults. Dasotraline is a novel compound that is a potent inhibitor of dopamine and norepinephrine transporters that achieves stable plasma concentrations with once-daily dosing. In this study, adult outpatients meeting DSM-IV-TR criteria for ADHD were randomized to 4 weeks of double-blind, once-daily treatment with dasotraline 4 and 8 mg/day or placebo. The primary efficacy end point was change from baseline at week 4 in the ADHD Rating Scale, Version IV (ADHD RS-IV) total score. Secondary efficacy end points included the Clinical Global Impression, Severity (CGI-S) scale, modified for ADHD symptoms. Least squares (LS) mean improvements at week 4 in ADHD RS-IV total score were significantly greater for dasotraline 8 mg/day vs placebo (-13.9 vs -9.7; P=0.019), and nonsignificantly greater for 4 mg/day (-12.4; P=0.076). The LS mean improvements in modified CGI-S were significantly greater at week 4 for dasotraline 8 mg/day vs placebo (-1.1 vs -0.7; P=0.013), and for 4 mg/day vs placebo (-1.1 vs -0.7; P=0.021). The most frequent adverse events reported were insomnia, decreased appetite, nausea, and dry mouth. Discontinuations due to treatment-emergent adverse events were 10.3% and 27.8% of patients in 4 and 8 mg/day treatment groups, respectively. This study provides preliminary evidence that once-daily dosing with dasotraline, a long-acting, dual monoamine reuptake inhibitor, may be a safe and efficacious treatment for adult ADHD.

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Published In

Neuropsychopharmacology

DOI

ISSN

0893-133X

Publication Date

2015

Volume

40

Issue

12

Start / End Page

2745 / 2752

Related Subject Headings

  • Psychiatry
  • 17 Psychology and Cognitive Sciences
  • 11 Medical and Health Sciences
 

Citation

APA
Chicago
ICMJE
MLA
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Koblan, K. S., Hopkins, S. C., Sarma, K., Jin, F., Goldman, R., Kollins, S. H., & Loebel, A. (2015). Dasotraline for the treatment of attention-deficit/hyperactivity disorder: A randomized, double-blind, placebo-controlled, proof-of-concept trial in adults. Neuropsychopharmacology, 40(12), 2745–2752. https://doi.org/10.1038/npp.2015.124
Koblan, K. S., S. C. Hopkins, K. Sarma, F. Jin, R. Goldman, S. H. Kollins, and A. Loebel. “Dasotraline for the treatment of attention-deficit/hyperactivity disorder: A randomized, double-blind, placebo-controlled, proof-of-concept trial in adults.” Neuropsychopharmacology 40, no. 12 (2015): 2745–52. https://doi.org/10.1038/npp.2015.124.
Koblan KS, Hopkins SC, Sarma K, Jin F, Goldman R, Kollins SH, et al. Dasotraline for the treatment of attention-deficit/hyperactivity disorder: A randomized, double-blind, placebo-controlled, proof-of-concept trial in adults. Neuropsychopharmacology. 2015;40(12):2745–52.
Koblan, K. S., et al. “Dasotraline for the treatment of attention-deficit/hyperactivity disorder: A randomized, double-blind, placebo-controlled, proof-of-concept trial in adults.” Neuropsychopharmacology, vol. 40, no. 12, 2015, pp. 2745–52. Scival, doi:10.1038/npp.2015.124.
Koblan KS, Hopkins SC, Sarma K, Jin F, Goldman R, Kollins SH, Loebel A. Dasotraline for the treatment of attention-deficit/hyperactivity disorder: A randomized, double-blind, placebo-controlled, proof-of-concept trial in adults. Neuropsychopharmacology. 2015;40(12):2745–2752.
Journal cover image

Published In

Neuropsychopharmacology

DOI

ISSN

0893-133X

Publication Date

2015

Volume

40

Issue

12

Start / End Page

2745 / 2752

Related Subject Headings

  • Psychiatry
  • 17 Psychology and Cognitive Sciences
  • 11 Medical and Health Sciences