PMID- 15908835
OWN - NLM
STAT- MEDLINE
DCOM- 20051004
LR  - 20061115
IS  - 0890-8567 (Print)
IS  - 0890-8567 (Linking)
VI  - 44
IP  - 6
DP  - 2005 Jun
TI  - Long-term tolerability and effectiveness of once-daily mixed amphetamine salts 
      (Adderall XR) in children with ADHD.
PG  - 530-8
AB  - OBJECTIVE: To evaluate the long-term tolerability and effectiveness of 
      extended-release mixed amphetamine salts (MAS XR; Adderall XR) in children with 
      attention-deficit/hyperactivity disorder (ADHD). METHOD: This was a 24-month, 
      multicenter, open-label extension of TWO placebo-controlled studies of MAS XR in 
      children with ADHD aged 6 to 12 years. Subjects (N=568) began treatment with MAS 
      XR 10 mg once daily, with 10-mg weekly dose increases to optimal effectiveness 
      (maximum dose, 30 mg/d). Effectiveness was assessed with analysis of quarterly 
      Conners Global Index Scale, Parent version (CGIS-P) scores. Tolerability was 
      assessed by monitoring adverse events (AEs), vital signs, physical examinations, 
      and serial laboratory tests. RESULTS: Significant improvements (>30%, p < .001) 
      in CGIS-P scores were maintained during long-term treatment. Treatment was well 
      tolerated, and most AEs were mild. The most frequently reported drug-related AEs 
      included anorexia, insomnia, and headache. The incidence of drug-related AEs 
      increased with increasing MAS XR dose, suggesting a dose relationship. Changes in 
      laboratory values and vital signs were modest and not clinically meaningful. 
      CONCLUSIONS: In children with ADHD, once-daily 10 mg-30 mg MAS XR was well 
      tolerated and significant behavioral improvements were consistently maintained 
      during 24 months of treatment.
FAU - McGough, James J
AU  - McGough JJ
AD  - Division of Child and Adolescent Psychiatry, UCLA Neuropsychiatric Institute, Los 
      Angeles, CA, USA. jmcgough@mednet.ucla.edu
FAU - Biederman, Joseph
AU  - Biederman J
FAU - Wigal, Sharon B
AU  - Wigal SB
FAU - Lopez, Frank A
AU  - Lopez FA
FAU - McCracken, James T
AU  - McCracken JT
FAU - Spencer, Thomas
AU  - Spencer T
FAU - Zhang, Yuxin
AU  - Zhang Y
FAU - Tulloch, Simon J
AU  - Tulloch SJ
LA  - eng
PT  - Clinical Trial
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
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 (Adderall)
RN  - 0 (Amphetamines)
RN  - 0 (Central Nervous System Stimulants)
RN  - 0 (Delayed-Action Preparations)
SB  - IM
MH  - Amphetamines/*administration & dosage/adverse effects
MH  - Attention Deficit Disorder with Hyperactivity/diagnosis/*drug therapy
MH  - Central Nervous System Stimulants/*administration & dosage/adverse effects
MH  - Child
MH  - Delayed-Action Preparations
MH  - Drug Administration Schedule
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Long-Term Care
MH  - Male
MH  - Personality Assessment
MH  - Treatment Outcome
EDAT- 2005/05/24 09:00
MHDA- 2005/10/05 09:00
CRDT- 2005/05/24 09:00
PHST- 2005/05/24 09:00 [pubmed]
PHST- 2005/10/05 09:00 [medline]
PHST- 2005/05/24 09:00 [entrez]
AID - S0890-8567(09)61628-2 [pii]
AID - 10.1097/01.chi.0000157550.94702.a2 [doi]
PST - ppublish
SO  - J Am Acad Child Adolesc Psychiatry. 2005 Jun;44(6):530-8. doi: 
      10.1097/01.chi.0000157550.94702.a2.