Binnie 1989.
| Methods | Randomized, double‐blind, cross‐over study. Two treatment arms: 1 placebo, and 1 lamotrigine. Baseline period = 8 weeks.Treatment I and II = 12 weeks each. Washout = 6 weeks, including taper period. |
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| Participants |
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| Interventions | Add‐on lamotrigine, or placebo. Median daily dose of lamotrigine was 200 mg. Participants on valproate received lower doses. | |
| Outcomes | (1) 50% responder rates. (2) Withdrawal from study for any reason. (3) Adverse effects. | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐generated random permuted blocks. |
| Allocation concealment (selection bias) | Low risk | Participants were allocated sequentially‐numbered sealed packages containing either lamotrigine or placebo. |
| Blinding (performance bias and detection bias) All outcomes | Low risk | Participants and parents were blinded. An unblinded investigator with knowledge of the medication and plasma concentrations instructed the blinded investigators about dispensing the trial medications. Identical tablets and packaging used. |
| Incomplete outcome data (attrition bias) | Low risk | No participants were excluded from analysis. No participant withdrew from the study during the first treatment phase. |
| Selective reporting (reporting bias) | Low risk | All outcomes stated in methods section of paper were reported in the results. There was no protocol available to check to priori outcomes. |
| Other bias | Unclear risk | This study was sponsored by GlaxoSmithKline, the manufactures of LTG. |