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. 2016 Feb 4;2016(2):CD009996. doi: 10.1002/14651858.CD009996.pub2

Giblin 2011.

Methods Single‐center, randomized, double‐blind, placebo‐controlled, parallel‐group trial
 Country: United States
Number of study sites: 1
 Statistical methods: modified ITT (all randomized children/adolescents who had both a baseline and a post‐randomization primary outcome assessment)
Participants Sample size: 24 children/adolescents with an ADHD diagnosis according to DSM‐IV‐TR criteria
 Dropouts: 0
 Psychiatric comorbid conditions: NR
 Age range: 6 years to 12 years
 Mean age (SD): 9.65 (2.2) years
 Sex: 10 (42%) males
 ADHD subtype: NR
Interventions Four interventions (24 children/adolescents participated in one of four interventions):
  1. Lisdexamphetamine (long acting), 30 mg/day, (n = 3)

  2. Lisdexamphetamine, (long acting), 50 mg/day, (n = 11)

  3. Lisdexamphetamine, (long acting), 70 mg/day, (n = 2)

  4. Placebo (n = 8)


Duration: 28 days
Outcomes Relevant outcomes:
  1. ADHD core symptom severity, assessed with ADHD Rating Scale, Fourth Version (investigator) and Conners' Parent Rating Scale ‐ Revised: Short Form*

  2. Clinical impression, assessed with Clinical Global Impression ‐ Severity scale

  3. Adverse events


Other outcomes:
  1. Sleep onset latency, assessed with polysomnography

  2. Wake time after sleep onset, assessed with polysomnography and actigraphy

  3. Number awakenings after sleep onset, assessed with polysomnography

  4. Total sleep time, assessed with polysomnography and actigraphy

  5. Sleep efficiency, assessed with actigraphy

Notes ClinicalTrials.gov identifier: not available
Authors' affiliation: private organization and pharmaceutical industry
 Study funding: pharmaceutical industry
 *Unpublished data sought on both outcome measures on three separate occasions but not obtained
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Method of random sequence generation not described
Allocation concealment (selection bias) Unclear risk Method of allocation concealment not described
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Incomplete outcome data not addressed; number of completers not reported
Selective reporting (reporting bias) Unclear risk Study protocol not available and the possibility of reporting bias could not be assessed
Other bias Low risk Study appears to be free of other biases
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Blinding of participants and personnel not described
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Blinding of outcome assessment not described