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

Donnelly 1989.

Methods Single‐center, randomized, double‐blind, placebo‐controlled, cross‐over trial
 Country: United States
Number of study sites: 1
 Statistical methods: ITT
Participants Sample size: 20 children/adolescents with an ADHD diagnosis according to DSM‐III criteria
 Dropouts: NR
 Psychiatric comorbid conditions: oppositional defiant disorder, conduct disorder, mental learning disorder, language disorder
 Age range: NR
 Mean age (SD): 8 (2) years
 Sex: 20 (100%) males
 ADHD subtype: NR
Interventions Three interventions (all 20 children/adolescents participated in each of the three interventions):
  1. Dextroamphetamine (short acting), weight‐based dose, 0.5 mg/kg/day, twice a day, (n = 20)

  2. Fenfluramine hydrochloride, weight‐based dosing increasing each week (0.6 mg/kg/day, 1.3 mg/kg/day, 2.0 mg/kg/day), twice a day, (n = 20)

  3. Placebo (n = 20)


Duration: 63 days (3 x 21‐day treatment periods)
Outcomes Relevant outcomes:
  1. ADHD core symptom severity, assessed with Conners' Teacher Rating Scale ‐ Short Form

  2. Clinical impression, assessed with Clinical Global Impression scale*

  3. Adverse events


Other outcomes:
  1. Vigiliance/attention and impulsivity, assessed with Conners' Continuous Performance Test

  2. Motor activity, assessed with activity monitor

  3. Biochemical and platelet measures (urine and plasma)

  4. Measures of prolactin

Notes ClinicalTrials identifier: not available
Authors' affiliation: university and National Institute of Mental Health
 Study funding: NR
Donnelly 1986 is a pilot study of Donnelly 1989 and therefore have overlapping data
*Unpublished data on the Clinical Global Impression scale sought on three separate occasions but not obtained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 sequence generation not described
Allocation concealment (selection bias) Unclear risk Method of allocation concealment not described
Incomplete outcome data (attrition bias) 
 All outcomes Low risk All recruited children/adolescents included in analyses. Only one dropout, with reasons provided
Selective reporting (reporting bias) Unclear risk Study protocol not available and the possibility of reporting bias could not be assessed
Other bias Unclear risk No information on the validity of the primary outcome measure provided
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