PMID- 28686474
OWN - NLM
STAT- MEDLINE
DCOM- 20180725
LR  - 20231112
IS  - 1557-8992 (Electronic)
IS  - 1044-5463 (Print)
IS  - 1044-5463 (Linking)
VI  - 27
IP  - 9
DP  - 2017 Nov
TI  - Randomized, Double-Blind, Placebo-Controlled Trial Demonstrates the Efficacy and 
      Safety of Oral Aripiprazole for the Treatment of Tourette's Disorder in Children 
      and Adolescents.
PG  - 771-781
LID - 10.1089/cap.2016.0026 [doi]
AB  - OBJECTIVES: Aripiprazole modulates dopaminergic and serotonergic pathways that 
      may play a role in the pathogenesis of Tourette's disorder (TD). This trial 
      evaluated the efficacy and safety of oral aripiprazole in the suppression of tics 
      in children and adolescents with TD. METHODS: This phase 3, randomized, 
      double-blind, placebo-controlled trial ( ClinicalTrials.gov , NCT01727700) 
      recruited patients who were 7-17 years old with a diagnosis of TD from hospitals, 
      private practices, and research clinics at 76 sites in the United States, Canada, 
      Hungary, and Italy. Patients were randomized in a 1:1:1 ratio by using an 
      interactive voice/web-response system to low-dose aripiprazole (5 mg/day if 
      <50 kg; 10 mg/day if >/=50 kg), high-dose aripiprazole (10 mg/day if <50 kg; 
      20 mg/day if >/=50 kg), or placebo for 8 weeks. Randomization was stratified by 
      region (North America or Europe) and baseline body weight (<50 kg vs. >/=50 kg). 
      The primary efficacy endpoint was mean change from baseline to week 8 in the Yale 
      Global Tic Severity Scale Total Tic Score (YGTSS-TTS) for the intent-to-treat 
      population. RESULTS: Between November 2012 and May 2013, 133 patients were 
      recruited and randomized to low-dose aripiprazole (n = 44), high-dose 
      aripiprazole (n = 45), or placebo (n = 44). Least-squares mean treatment 
      differences versus placebo in change from baseline to week 8 in the YGTSS-TTS 
      were statistically significant (high dose, -9.9 [95% confidence interval, CI, 
      -13.8 to -5.9], low dose, -6.3 [95% CI, -10.2 to -2.3]). At week 8, 69% (29/42) 
      of patients in the low-dose and 74% (26/35) of patients in the high-dose 
      aripiprazole groups demonstrated a Clinical Global Impression-Tourette's Syndrome 
      improvement score of 1 (very much improved) or 2 (much improved) compared with 
      38% (16/42) in the placebo group. The most common adverse events (AEs) were 
      sedation (low dose, 8/44 [18.2%], high dose, 4/45 [8.9%], placebo, 1/44 [2.3%]), 
      somnolence (low dose, 5/44 [11.4%], high dose, 7/45 [15.6%], placebo, 1/44 
      [2.3%]), and fatigue (low dose, 3/44 [6.8%], high dose, 7/45 [15.6%], placebo, 
      0). No serious AEs or deaths occurred. CONCLUSIONS: This study indicates that 
      oral aripiprazole is a safe and effective treatment for tics in children and 
      adolescents with TD.
FAU - Sallee, Floyd
AU  - Sallee F
AD  - 1 Department of Psychiatry, University of Cincinnati College of Medicine , 
      Cincinnati, Ohio.
FAU - Kohegyi, Eva
AU  - Kohegyi E
AD  - 2 Otsuka Pharmaceutical Development & Commercialization, Inc. , Princeton, New 
      Jersey.
FAU - Zhao, Joan
AU  - Zhao J
AD  - 2 Otsuka Pharmaceutical Development & Commercialization, Inc. , Princeton, New 
      Jersey.
FAU - McQuade, Robert
AU  - McQuade R
AD  - 2 Otsuka Pharmaceutical Development & Commercialization, Inc. , Princeton, New 
      Jersey.
FAU - Cox, Kevin
AU  - Cox K
AD  - 2 Otsuka Pharmaceutical Development & Commercialization, Inc. , Princeton, New 
      Jersey.
FAU - Sanchez, Raymond
AU  - Sanchez R
AD  - 2 Otsuka Pharmaceutical Development & Commercialization, Inc. , Princeton, New 
      Jersey.
FAU - van Beek, Alet
AU  - van Beek A
AD  - 3 Mylan , Canonsburg, Pennsylvania.
FAU - Nyilas, Margaretta
AU  - Nyilas M
AD  - 2 Otsuka Pharmaceutical Development & Commercialization, Inc. , Princeton, New 
      Jersey.
FAU - Carson, William
AU  - Carson W
AD  - 2 Otsuka Pharmaceutical Development & Commercialization, Inc. , Princeton, New 
      Jersey.
FAU - Kurlan, Roger
AU  - Kurlan R
AD  - 4 Atlantic Neuroscience Institute , Overlook Medical Center, Summit, New Jersey.
LA  - eng
SI  - ClinicalTrials.gov/NCT01727700
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20170707
PL  - United States
TA  - J Child Adolesc Psychopharmacol
JT  - Journal of child and adolescent psychopharmacology
JID - 9105358
RN  - 0 (Antipsychotic Agents)
RN  - 82VFR53I78 (Aripiprazole)
SB  - IM
MH  - Adolescent
MH  - Antipsychotic Agents/*administration & dosage
MH  - Aripiprazole/*administration & dosage
MH  - Canada
MH  - Child
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Italy
MH  - Male
MH  - Psychiatric Status Rating Scales
MH  - Severity of Illness Index
MH  - Tourette Syndrome/*drug therapy
MH  - Treatment Outcome
MH  - United States
PMC - PMC5689110
OTO - NOTNLM
OT  - Tourette's disorder
OT  - adolescent
OT  - aripiprazole
OT  - children
OT  - tics
EDAT- 2017/07/08 06:00
MHDA- 2018/07/26 06:00
PMCR- 2017/11/01
CRDT- 2017/07/08 06:00
PHST- 2017/07/08 06:00 [pubmed]
PHST- 2018/07/26 06:00 [medline]
PHST- 2017/07/08 06:00 [entrez]
PHST- 2017/11/01 00:00 [pmc-release]
AID - 10.1089/cap.2016.0026 [pii]
AID - 10.1089/cap.2016.0026 [doi]
PST - ppublish
SO  - J Child Adolesc Psychopharmacol. 2017 Nov;27(9):771-781. doi: 
      10.1089/cap.2016.0026. Epub 2017 Jul 7.