Acetyl-L-carnitine (ALC) in attention-deficit/hyperactivity disorder: a multi-site, placebo-controlled pilot trial.
OBJECTIVE
To determine whether acetyl-L-carnitine (ALC), a metabolite necessary for energy metabolism and essential fatty acid anabolism, might help attention-deficit/hyperactivity disorder (ADHD). Trials in Down's syndrome, migraine, and Alzheimer's disease showed benefit for attention. A preliminary trial in ADHD using L-carnitine reported significant benefit.


METHODS
A multi-site 16-week pilot study randomized 112 children (83 boys, 29 girls) age 5-12 with systematically diagnosed ADHD to placebo or ALC in weight-based doses from 500 to 1500 mg b.i.d. The 2001 revisions of the Conners' parent and teacher scales (including DSM-IV ADHD symptoms) were administered at baseline, 8, 12, and 16 weeks. Analyses were ANOVA of change from baseline to 16 weeks with treatment, center, and treatment-by-center interaction as independent variables.


RESULTS
The primary intent-to-treat analysis, of 9 DSM-IV teacher-rated inattentive symptoms, was not significant. However, secondary analyses were interesting. There was significant (p = 0.02) moderation by subtype: superiority of ALC over placebo in the inattentive type, with an opposite tendency in combined type. There was also a geographic effect (p = 0.047). Side effects were negligible; electrocardiograms, lab work, and physical exam unremarkable.


CONCLUSIONS
ALC appears safe, but with no effect on the overall ADHD population (especially combined type). It deserves further exploration for possible benefit specifically in the inattentive type.
Arnold
L Eugene
LE
The Ohio State University Nisonger Center, Columbus, OH, USA.
Amato
Antonino
A
Bozzolo
Hernan
H
Hollway
Jill
J
Cook
Amy
A
Ramadan
Yaser
Y
Crowl
Lindsay
L
Zhang
Dan
D
Thompson
Susan
S
Testa
Giussepe
G
Kliewer
Vernon
V
Wigal
Timothy
T
McBurnett
Keith
K
Manos
Michael
M
D000108:Acetylcarnitine / Q000009:adverse effects / Q000627:therapeutic use*; D000704:Analysis of Variance; D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy* / Q000503:physiopathology; D002648:Child; D002675:Child, Preschool; D004562:Electrocardiography; D005178:Faculty; D005260:Female; D006801:Humans; D008297:Male; D018697:Nootropic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D010290:Parents; D010865:Pilot Projects; D011569:Psychiatric Status Rating Scales; D013997:Time Factors; D016896:Treatment Outcome
D018697:Nootropic Agents; D000108:Acetylcarnitine