Robertson 1985.
Study characteristics | ||
Methods | A single‐centre, randomised, double‐blind, controlled trial (UK) Baseline period: unclear Treatment period: 12 weeks (6 weeks for all 3 arms of trial, then 6 weeks for the 2 antidepressants only) | |
Participants | 42 people with epilepsy exceeding 15 points on the HAMD‐21 scale for depression 26 females and 13 males Aged 18 to 60 years | |
Interventions | Amitriptyline (N = 14) 25 mg TDS Nomifensine (N = 14) 25mg TDS Placebo (N = 14) |
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Outcomes | 1) Improvement in depressive symptoms 2) Seizure frequency 3) Adverse effects |
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Notes | 39 people included in the analysis. At 6 weeks, non‐responders in the active drug arms had dose doubled, and those in the placebo arm were withdrawn from the study | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random number codes used, however generation of this randomisation sequence is unclear |
Allocation concealment (selection bias) | Low risk | Pharmacy‐controlled allocation |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Study personnel and participants blinded |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcome assessor blinded |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Missing data detected and attrition reported |
Selective reporting (reporting bias) | Low risk | Outcomes stated in methods section of report are present in the results. No protocol available |
Other bias | Unclear risk | After 6 weeks, placebo group removed from trial; only active antidepressant treatment groups continued in the trial |