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. 2021 Apr 16;2021(4):CD010682. doi: 10.1002/14651858.CD010682.pub3

Gilliam 2019.

Study characteristics
Methods Multi‐centre, randomised controlled trial conducted in the USA
Baseline period: 3 month retrospective baseline (seizures)
Treatment period:16 weeks
Participants 140 participants; 77 female
21 to 75 years old
58% focal epilepsy
CES‐D score >14
Interventions Sertraline 50 mg/day to 200 mg/day versus CBT
Outcomes BDI, CES‐D, seizure recurrence and monthly frequency, AEP, adverse events
Notes ITT analysis, 49/72 in sertraline group completed assigned treatment, 49/68 in CBT group completed assigned treatment
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Simple non‐stratified computerised randomisation code generated by an investigator not otherwise involved in the study
Allocation concealment (selection bias) Low risk Treatment assignment obtained by telephone communication (centralised randomisation)
Blinding of participants and personnel (performance bias)
All outcomes High risk Blinding of participants and personnel not possible by design (sertraline or CBT)
Blinding of outcome assessment (detection bias)
All outcomes Low risk Site investigators blinded to outcome assessment but research assistants implementing study procedures not blinded
Incomplete outcome data (attrition bias)
All outcomes Low risk 23/72 participants (32%) in the sertraline group and 19/68 participants (28%) in the CBT group did not complete treatment. Intention‐to‐treat analysis imputed missing data by multiple imputation
Selective reporting (reporting bias) Low risk Outcomes stated in methods section of report are present in the results. No protocol available
Other bias High risk High risk of recall bias as seizure rates were collected retrospectively at baseline