Methods | A single‐centre, non‐randomised, uncontrolled, prospective before and after study (Brazil) Baseline period: Not reported Treatment period: Mean 25.8 months (range 12‐78) |
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Participants | 36 children and adolescents with focal epilepsy and diagnosis of depression 19 females and 17 males Aged 5 to 18 years, mean: 12.7 years | |
Interventions | Sertraline up to 200 mg per day, mean dose 111.5 mg per day (50 to 200 mg) Fluoxetine up to 80 mg per day, mean dose 45.7 mg per day (20 to 80 mg) |
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Outcomes | 1) Seizure severity 2) Improvement in depressive symptoms 3) Adverse effects |
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Notes | No drop‐outs | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | No randomisation methods used |
Allocation concealment (selection bias) | High risk | No methods for concealing allocation used |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants not blinded; unclear about other study personnel. Rated 4 on scale for risk of bias |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Unclear whether outcome assessors blinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing data |
Selective reporting (reporting bias) | Low risk | Outcomes stated in methods section of report are present in the results. No protocol available. Rated 2 on scale for risk of bias |
Other bias | Low risk | No other risk of bias detected. Rated 1 on scale for risk of bias |
Confounding variables | High risk | Some confounding variables considered but not adjusted for in the analysis. Rated 4 on scale for risk of bias |