Effectiveness, safety, and tolerability of lisdexamfetamine dimesylate in children with attention-deficit/hyperactivity disorder: an open-label, dose-optimization study.
OBJECTIVE
The aim of this study was to assess the effectiveness and safety of lisdexamfetamine dimesylate (LDX) in children with attention-deficit/hyperactivity disorder (ADHD).


METHODS
This was a 7-week, open-label study evaluating 20, 30, 40, 50, 60, or 70 mg/day LDX in 318 children aged 6-12 years with ADHD. The ADHD Rating Scale IV (ADHD-RS-IV) was the primary efficacy assessment. Secondary measures included the Clinical Global Impressions-Improvement (CGI-I), Expression and Emotion Scale for Children (EESC), and Behavior Rating Inventory of Executive Function (BRIEF). Safety assessments included treatment-emergent adverse events (TEAEs), vital signs, and electrocardiograms.


RESULTS
At end point, mean (standard deviation [SD]) improvement from baseline in ADHD-RS-IV total score was 28.6 (10.9) (p < 0.0001). Most subjects (89.9%) were rated "improved" (i.e., CGI-I 1 or 2). Improvements from baseline were observed in the EESC total and subscale scores (p < or = 0.0002). LDX treatment resulted in significant improvement on the Global Executive Composite, Behavioral Regulation, and Metacognition indices of the BRIEF (p < 0.0001). TEAEs (incidences > or =10%) were decreased appetite, decreased weight, irritability, insomnia, headache, upper abdominal pain, and initial insomnia.


CONCLUSIONS
LDX was effective and generally well tolerated with a safety profile consistent with long-acting stimulant use. There was overall improvement in ADHD symptoms and executive function measures and no worsening of emotional expression measures.


BACKGROUND
clinicaltrials.gov Identifier: NCT00500071.
Findling
Robert L
RL
University Hospitals Case Medical Center, Cleveland, Ohio 44106, USA. robert.findling@UHhospitals.org
Ginsberg
Lawrence D
LD
Jain
Rakesh
R
Gao
Joseph
J
D001066:Appetite / Q000187:drug effects; D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy* / Q000523:psychology; D000697:Central Nervous System Stimulants / Q000008:administration & dosage* / Q000009:adverse effects; D002648:Child; D003913:Dextroamphetamine / Q000008:administration & dosage* / Q000009:adverse effects; D004305:Dose-Response Relationship, Drug; D004562:Electrocardiography; D056344:Executive Function / Q000187:drug effects*; D019260:Expressed Emotion / Q000187:drug effects*; D005260:Female; D006801:Humans; D000069478:Lisdexamfetamine Dimesylate; D008297:Male; D017060:Patient Satisfaction; D011355:Prodrugs / Q000008:administration & dosage* / Q000009:adverse effects; D011569:Psychiatric Status Rating Scales; D012720:Severity of Illness Index; D016896:Treatment Outcome; D015431:Weight Loss
D000697:Central Nervous System Stimulants; D011355:Prodrugs; D000069478:Lisdexamfetamine Dimesylate; D003913:Dextroamphetamine