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. 2023 Oct 9;2023(10):CD011769. doi: 10.1002/14651858.CD011769.pub2

Eslamzadeh 2018.

Study characteristics
Methods 8‐week parallel trial of atomoxetine + risperidone versus placebo + risperidone
Participants Inclusion criteria:
  • meet the DSM‐5 for ASD

  • 6‐17 years of age


Exclusion criteria:
  • concomitant ADHD

  • other psychiatric disorders

  • any other medical conditions

  • use of any psychotropic apart from risperidone

  • IQ < 50


Location/setting: outpatient clinic of Ibnesina hospital, Iran
Mean IQ: details not provided
Mean age: 8.0 years
Gender: 6 female, 34 male
Sample size: 40‐20 each group
Number analysed: 20 in each group completed the trial
Reasons for dropouts: 3 from atomoxetine group discontinued due to withdrawing consent (1) and AEs (2) and 1 from placebo group did not start the trial.
Baseline ABC‐I or other BoC scale: not reported
Timing of outcome assessments: "patients were evaluated at baseline, 4 weeks and 8 weeks after the administration of the drug".
Concomitant medications: apart from risperidone, participants could not be taking any other psychotropic drugs.
Previous medications ‐ not reported
Interventions Intervention (atomoxetine + risperidone): atomoxetine was given at 0.5 mg/kg/day at the start and increasing every 5 days up to a maximum of 1.2 mg/kg/day for 8 weeks. All participants were currently taking risperidone ranging from 1‐4 mg/day
Comparator (placebo + risperidone): placebo plus usual intake of risperidone for 8 weeks
Outcomes Primary outcomes: AEs
Secondary outcomes: tolerability
Notes Study start date: August 2015
Study end date: September 2016
Funding: "This work was extracted from a residency thesis in the Mashhad University of Science. There was no organizational financial support".
Conflicts of interest: "There are no conflicts of interest".
Other: trial registry IRCT2016022826802N1
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Details not provided
Allocation concealment (selection bias) Unclear risk Details not provided
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Quote: "double blind". No further details provided
Blinding of outcome assessment (detection bias)
All outcomes High risk The trial registry stated that investigators were not blinded.
Incomplete outcome data (attrition bias)
All outcomes Unclear risk The numbers that discontinued in the treatment group do not match what was analysed (i.e they report 3 dropouts but 4 not included in the analysis).
Selective reporting (reporting bias) Low risk The outcomes listed on the clinical registry were reported
Other bias High risk
  • The contact author is also on the ethics committee at the university funding the study.

  • The contact author is a peer‐reviewer for one of the journals in which some of their studies are published.