PMID- 32926604
OWN - NLM
STAT- MEDLINE
DCOM- 20201123
LR  - 20201123
IS  - 1555-2101 (Electronic)
IS  - 0160-6689 (Linking)
VI  - 81
IP  - 5
DP  - 2020 Sep 8
TI  - Efficacy and Safety of Dasotraline in Adults With Binge-Eating Disorder: A 
      Randomized, Placebo-Controlled, Flexible-Dose Clinical Trial.
LID - 19m13068 [pii]
LID - 10.4088/JCP.19m13068 [doi]
AB  - 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.
CI  - (c) Copyright 2020 Physicians Postgraduate Press, Inc.
FAU - McElroy, Susan L
AU  - McElroy SL
AD  - Lindner Center of HOPE, Mason, Ohio, USA.
AD  - Biological Psychiatry Program, University of Cincinnati Medical College, 
      Cincinnati, Ohio, USA.
FAU - Hudson, James I
AU  - Hudson JI
AD  - Biological Psychiatry Laboratory, McLean Hospital, Belmont, Massachusetts; and 
      Department of Psychiatry, Harvard Medical School, Boston, Massachusetts, USA.
FAU - Grilo, Carlos M
AU  - Grilo CM
AD  - Department of Psychiatry, Yale School of Medicine, New Haven, Connecticut, USA.
FAU - Guerdjikova, Anna I
AU  - Guerdjikova AI
AD  - Lindner Center of HOPE, Mason, Ohio, USA.
AD  - Biological Psychiatry Program, University of Cincinnati Medical College, 
      Cincinnati, Ohio, USA.
FAU - Deng, Ling
AU  - Deng L
AD  - Sunovion Pharmaceuticals Inc., Marlborough, Massachusetts, USA.
FAU - Koblan, Kenneth S
AU  - Koblan KS
AD  - Sunovion Pharmaceuticals Inc., Marlborough, Massachusetts, USA.
FAU - Goldman, Robert
AU  - Goldman R
AD  - Sunovion Pharmaceuticals Inc., Marlborough, Massachusetts, USA.
FAU - Navia, Bradford
AU  - Navia B
AD  - Sunovion Pharmaceuticals Inc., 84 Waterford Dr, Marlborough, MA 01752. 
      bradford.navia@sunovion.com.
AD  - Sunovion Pharmaceuticals Inc., Marlborough, Massachusetts, USA.
FAU - Hopkins, Seth
AU  - Hopkins S
AD  - Sunovion Pharmaceuticals Inc., Marlborough, Massachusetts, USA.
FAU - Loebel, Antony
AU  - Loebel A
AD  - Sunovion Pharmaceuticals Inc., Marlborough, Massachusetts, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT02564588
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20200908
PL  - United States
TA  - J Clin Psychiatry
JT  - The Journal of clinical psychiatry
JID - 7801243
RN  - 0 (Dopamine Antagonists)
RN  - 4D28EY0L5T (4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydronaphthalen-1-amine)
RN  - 9753I242R5 (1-Naphthylamine)
SB  - IM
MH  - 1-Naphthylamine/administration & dosage/adverse effects/*analogs & 
      derivatives/therapeutic use
MH  - Adult
MH  - Binge-Eating Disorder/*drug therapy
MH  - Dopamine Antagonists/administration & dosage/adverse effects/*therapeutic use
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Male
MH  - Treatment Outcome
EDAT- 2020/09/15 06:00
MHDA- 2020/11/24 06:00
CRDT- 2020/09/14 15:52
PHST- 2019/08/30 00:00 [received]
PHST- 2020/04/29 00:00 [accepted]
PHST- 2020/09/14 15:52 [entrez]
PHST- 2020/09/15 06:00 [pubmed]
PHST- 2020/11/24 06:00 [medline]
AID - 19m13068 [pii]
AID - 10.4088/JCP.19m13068 [doi]
PST - epublish
SO  - J Clin Psychiatry. 2020 Sep 8;81(5):19m13068. doi: 10.4088/JCP.19m13068.