PMID- 30694697
OWN - NLM
STAT- MEDLINE
DCOM- 20200424
LR  - 20200424
IS  - 1557-8992 (Electronic)
IS  - 1044-5463 (Linking)
VI  - 29
IP  - 2
DP  - 2019 Mar
TI  - Dasotraline in Children with Attention-Deficit/Hyperactivity Disorder: A 
      Six-Week, Placebo-Controlled, Fixed-Dose Trial.
PG  - 80-89
LID - 10.1089/cap.2018.0083 [doi]
AB  - OBJECTIVE: Dasotraline is a potent inhibitor of presynaptic dopamine and 
      norepinephrine reuptake with a pharmacokinetic profile characterized by slow 
      absorption and a long elimination half-life. The aim of this study was to 
      evaluate the efficacy and safety of dasotraline in children with 
      attention-deficit/hyperactivity disorder (ADHD). METHODS: Children aged 6-12 
      years with a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition 
      (DSM-5) diagnosis of ADHD were randomized to 6 weeks of double-blind once-daily 
      treatment with dasotraline (2 or 4 mg) or placebo. The primary efficacy endpoint 
      was change from baseline in the ADHD Rating Scale Version IV-Home Version (ADHD 
      RS-IV HV) total score at week 6. RESULTS: A total of 342 patients were randomized 
      to dasotraline or placebo (mean age 9.1 years, 66.7% male). Treatment with 
      dasotraline was associated with significant improvement at study endpoint in the 
      ADHD RS-IV HV total score for the 4 mg/day dose versus placebo (-17.5 vs. -11.4; 
      p < 0.001; effect size [ES], 0.48), but not for the 2 mg/day dose (-11.8 vs. 
      -11.4; ns; ES, 0.03). A regression analysis confirmed a significant linear 
      dose-response relationship for dasotraline. Significant improvement for 
      dasotraline 4 mg/day dose versus placebo was also observed across the majority of 
      secondary efficacy endpoints, including the Clinical Global Impression 
      (CGI)-Severity score, the Conners Parent Rating Scale-Revised scale (CPRS-R) ADHD 
      index score, and subscale measures of hyperactivity and inattentiveness. 
      Discontinuation rates due to adverse events (AEs) were higher in the dasotraline 
      4 mg/day group (12.2%) compared with the 2 mg/day group (6.3%) and placebo 
      (1.7%). The most frequent AEs associated with dasotraline were insomnia, 
      decreased appetite, decreased weight, and irritability. Psychosis-related 
      symptoms were reported as AEs by 7/219 patients treated with dasotraline in this 
      study. There were no serious AEs or clinically meaningful changes in blood 
      pressure or heart rate on dasotraline. CONCLUSION: In this placebo-controlled 
      study, treatment with dasotraline 4 mg/day significantly improved ADHD symptoms 
      and behaviors, including attention and hyperactivity, in children aged 6-12 
      years. The most frequently reported AEs observed on dasotraline included 
      insomnia, decreased appetite, decreased weight, and irritability.
FAU - Findling, Robert L
AU  - Findling RL
AD  - 1 Kennedy Krieger Institute/Johns Hopkins University , Baltimore, Maryland.
FAU - Adler, Lenard A
AU  - Adler LA
AD  - 2 New York University Langone Medical Center , New York, New York.
FAU - Spencer, Thomas J
AU  - Spencer TJ
AD  - 3 Massachusetts General Hospital , Boston, Massachusetts.
FAU - Goldman, Robert
AU  - Goldman R
AD  - 4 Sunovion Pharmaceuticals, Inc. , Marlborough, Massachusetts and Fort Lee, New 
      Jersey.
FAU - Hopkins, Seth C
AU  - Hopkins SC
AD  - 4 Sunovion Pharmaceuticals, Inc. , Marlborough, Massachusetts and Fort Lee, New 
      Jersey.
FAU - Koblan, Kenneth S
AU  - Koblan KS
AD  - 4 Sunovion Pharmaceuticals, Inc. , Marlborough, Massachusetts and Fort Lee, New 
      Jersey.
FAU - Kent, Justine
AU  - Kent J
AD  - 4 Sunovion Pharmaceuticals, Inc. , Marlborough, Massachusetts and Fort Lee, New 
      Jersey.
FAU - Hsu, Jay
AU  - Hsu J
AD  - 4 Sunovion Pharmaceuticals, Inc. , Marlborough, Massachusetts and Fort Lee, New 
      Jersey.
FAU - Loebel, Antony
AU  - Loebel A
AD  - 4 Sunovion Pharmaceuticals, Inc. , Marlborough, Massachusetts and Fort Lee, New 
      Jersey.
LA  - eng
SI  - ClinicalTrials.gov/NCT02428088
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20190129
PL  - United States
TA  - J Child Adolesc Psychopharmacol
JT  - Journal of child and adolescent psychopharmacology
JID - 9105358
RN  - 0 (Dopamine Uptake Inhibitors)
RN  - 4D28EY0L5T (4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydronaphthalen-1-amine)
RN  - 9753I242R5 (1-Naphthylamine)
SB  - IM
CIN - J Child Adolesc Psychopharmacol. 2019 Nov;29(9):725. PMID: 31094581
MH  - 1-Naphthylamine/adverse effects/*analogs & derivatives/therapeutic use
MH  - Attention Deficit Disorder with Hyperactivity/*drug therapy/physiopathology
MH  - Child
MH  - Dopamine Uptake Inhibitors/adverse effects/*therapeutic use
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Male
MH  - Treatment Outcome
OTO - NOTNLM
OT  - attention-deficit/hyperactivity disorder
OT  - dasotraline serotonin and noradrenaline reuptake inhibitor
OT  - randomized controlled trial
EDAT- 2019/01/30 06:00
MHDA- 2020/04/25 06:00
CRDT- 2019/01/30 06:00
PHST- 2019/01/30 06:00 [pubmed]
PHST- 2020/04/25 06:00 [medline]
PHST- 2019/01/30 06:00 [entrez]
AID - 10.1089/cap.2018.0083 [doi]
PST - ppublish
SO  - J Child Adolesc Psychopharmacol. 2019 Mar;29(2):80-89. doi: 
      10.1089/cap.2018.0083. Epub 2019 Jan 29.