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

Findling 2011.

Methods Multi‐center, randomized, double‐blind, placebo‐controlled, parallel‐group trial
 Country: United States
 Number of study sites: 45
 Statistical methods: modified ITT (last observation carried forward)
Participants Sample size: 314 children/adolescents with an ADHD diagnosis according to DSM‐IV‐TR criteria
 Dropouts: 52
 Psychiatric comorbid conditions: NR
 Age range: 13 years to 17 years
 Mean age (SD): 14.6 (1.31) years
 Sex: 249 (79%) males
 ADHD subtype: 203 (65%) combined
Interventions Four interventions (312 children/adolescents participated in one of four interventions):
  1. Lisdexamphetamine (long acting), 30 mg/day, (n = 78*)

  2. Lisdexamphetamine (long acting), 50 mg/day (30 mg/day for week 1 with forced dose escalation to 50 mg/day for weeks 2 to 4), (n = 77*)

  3. Lisdexamphetamine, long acting, 70 mg/day (30 mg/day for week 1 with forced dose escalation to 50 mg/day for week 2 and 70 mg/day for weeks 3 to 4), (n = 78*)

  4. Placebo (n = 79)


Duration: 28 days
Outcomes Relevant outcomes:
  1. ADHD core symptom severity, assessed with ADHD Rating Scale, Fourth Version (clinician ratings)

  2. Clinical impression, assessed with Clinical Global Impression ‐ Severity and Clinical Global Impression ‐ Improvement scales

  3. Quality of life, assessed with Youth Quality of Life ‐ Research Version (YQOL‐R)

  4. Retention: proportion of participants who completed the trial

  5. Number of participants who dropped out due to lack of efficacy

  6. Number of participants who experienced at least one adverse event

  7. Number of participants who dropped out due to any adverse event

  8. Adverse events

Notes ClinicalTrials.gov identifier: NCT00735371
Authors' affiliation: university and pharmaceutical industry
 Study funding: pharmaceutical industry
 *Numbers are based on participants included in the safety analysis
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Sequence generated by a web‐based computer system
Allocation concealment (selection bias) Low risk Allocation concealment ensured using the web‐based computer system and third party, which serially numbered treatment bottles for each participant
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Moderate attrition (16%). However, 98% of randomized children/adolescents included in primary efficacy analysis. Reasons for dropouts provided
Selective reporting (reporting bias) Low risk Data provided on all outcomes listed in the registered protocol. Study appears to be free of selective reporting
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