Schapel 1993.
| Methods | Randomised, double‐blind, cross‐over study. Two treatment arms: 1 placebo, 1 lamotrigine. Pre‐randomization baseline = 12 weeks. Treatment I and II = 12 weeks each. Washout I and II = 4 weeks each, including 1 week taper. |
|
| Participants |
|
|
| Interventions | Add‐on lamotrigine or placebo. Median daily dose of lamotrigine was 300 mg. Participants receiving valproate received lower doses. | |
| Outcomes | (1) 50% responder rates. (2) Withdrawal from study for any reason. (3) Adverse effects. | |
| Notes | Banks 1991 is linked to this study and investigated cognitive functions (concentration and attention; general cerebral efficiency; mnestic function). | |
| 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 by sequentially numbered, sealed packages containing either lamotrigine or placebo. |
| Blinding (performance bias and detection bias) All outcomes | Unclear risk | No details provided regarding blinding of participants, study personnel, and outcome assessors. All treatments and packaging were identical. Pre‐packed coded medication dispensed by pharmacy. |
| Incomplete outcome data (attrition bias) | Low risk | No participants were excluded from analysis. None withdrew from the study. |
| Selective reporting (reporting bias) | Low risk | Protocol unavailable, but appears all expected and pre‐specified outcomes were reported. |
| Other bias | Unclear risk | This study was sponsored by GlaxoSmithKline, the manufactures of LTG. |