PMID- 22176941
OWN - NLM
STAT- MEDLINE
DCOM- 20120426
LR  - 20220310
IS  - 1527-5418 (Electronic)
IS  - 0890-8567 (Linking)
VI  - 51
IP  - 1
DP  - 2012 Jan
TI  - A controlled trial of extended-release guanfacine and psychostimulants for 
      attention-deficit/hyperactivity disorder.
PG  - 74-85.e2
LID - 10.1016/j.jaac.2011.10.012 [doi]
AB  - OBJECTIVE: To examine efficacy, tolerability, and safety of guanfacine extended 
      release (GXR; </=4 mg/d) adjunctive to a long-acting psychostimulant for the 
      treatment of attention-deficit/hyperactivity disorder (ADHD) in children and 
      adolescents 6 to 17 years of age with suboptimal, but partial, response to 
      psychostimulant alone. METHOD: In this multicenter, 9-week, double-blind, 
      placebo-controlled, dose-optimization study, subjects (N = 461) continued their 
      stable dose of psychostimulant given in the morning and were randomized to 
      receive GXR in the morning (GXR AM), GXR in the evening (GXR PM), or placebo. 
      Efficacy measures included ADHD Rating Scale IV (ADHD-RS-IV) and Clinical Global 
      Impressions of Severity of Illness (CGI-S) and Improvement (CGI-I) scales. Safety 
      measures included adverse events (AEs), vital signs, electrocardiograms, and 
      laboratory evaluations. RESULTS: At endpoint, GXR treatment groups showed 
      significantly greater improvement from baseline ADHD-RS-IV total scores compared 
      with placebo plus psychostimulant (GXR AM, p = .002; GXR PM, p < .001). 
      Significant benefits of GXR treatment versus placebo plus psychostimulant were 
      observed on the CGI-S (GXR AM, p = .013; GXR PM, p < .001) and CGI-I (GXR AM, p = 
      .024; GXR PM, p = .003). At endpoint, small mean decreases in pulse, systolic, 
      and diastolic blood pressure were observed in GXR treatment groups versus placebo 
      plus psychostimulant. No new safety signals emerged following administration of 
      GXR with psychostimulants versus psychostimulants alone. Most AEs were mild to 
      moderate in severity. CONCLUSIONS: Morning or evening GXR administered 
      adjunctively to a psychostimulant showed significantly greater improvement over 
      placebo plus psychostimulant in ADHD symptoms and generated no new safety 
      signals. Clinical trial registration information-Efficacy and Safety of SPD503 in 
      Combination With Psychostimulants; http://www.clinicaltrials.gov; NCT00734578.
CI  - Copyright (c) 2012 American Academy of Child and Adolescent Psychiatry. Published 
      by Elsevier Inc. All rights reserved.
FAU - Wilens, Timothy E
AU  - Wilens TE
AD  - Massachusetts General Hospital, Boston, MA, USA. twilens@partners.org
FAU - Bukstein, Oscar
AU  - Bukstein O
FAU - Brams, Matthew
AU  - Brams M
FAU - Cutler, Andrew J
AU  - Cutler AJ
FAU - Childress, Ann
AU  - Childress A
FAU - Rugino, Thomas
AU  - Rugino T
FAU - Lyne, Andrew
AU  - Lyne A
FAU - Grannis, Kara
AU  - Grannis K
FAU - Youcha, Sharon
AU  - Youcha S
LA  - eng
SI  - ClinicalTrials.gov/NCT00734578
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, N.I.H., Extramural
PT  - Research Support, Non-U.S. Gov't
DEP - 20111125
PL  - United States
TA  - J Am Acad Child Adolesc Psychiatry
JT  - Journal of the American Academy of Child and Adolescent Psychiatry
JID - 8704565
RN  - 0 (Adrenergic alpha-Agonists)
RN  - 0 (Central Nervous System Stimulants)
RN  - 0 (Delayed-Action Preparations)
RN  - 0 (Placebos)
RN  - 30OMY4G3MK (Guanfacine)
SB  - IM
MH  - Adolescent
MH  - Adrenergic alpha-Agonists/*administration & dosage/*adverse effects
MH  - Attention Deficit Disorder with Hyperactivity/*drug therapy
MH  - Central Nervous System Stimulants/therapeutic use
MH  - Child
MH  - Delayed-Action Preparations
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Drug Therapy, Combination
MH  - Female
MH  - Guanfacine/*administration & dosage/*adverse effects
MH  - Humans
MH  - Male
MH  - Placebos
MH  - Psychiatric Status Rating Scales
MH  - Severity of Illness Index
MH  - Treatment Outcome
EDAT- 2011/12/20 06:00
MHDA- 2012/04/27 06:00
CRDT- 2011/12/20 06:00
PHST- 2011/05/12 00:00 [received]
PHST- 2011/08/25 00:00 [revised]
PHST- 2011/10/21 00:00 [accepted]
PHST- 2011/12/20 06:00 [entrez]
PHST- 2011/12/20 06:00 [pubmed]
PHST- 2012/04/27 06:00 [medline]
AID - S0890-8567(11)00950-6 [pii]
AID - 10.1016/j.jaac.2011.10.012 [doi]
PST - ppublish
SO  - J Am Acad Child Adolesc Psychiatry. 2012 Jan;51(1):74-85.e2. doi: 
      10.1016/j.jaac.2011.10.012. Epub 2011 Nov 25.