Eslamzadeh 2018.
Study characteristics | ||
Methods | 8‐week parallel trial of atomoxetine + risperidone versus placebo + risperidone | |
Participants | Inclusion criteria:
Exclusion criteria:
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 |
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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 |
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Outcomes | Primary outcomes: AEs Secondary outcomes: tolerability |
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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 |
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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 |
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