Abstracts

To determine the effect of lamotrigine (LTG) on mood states when added to other antiepileptic drugs(AEDs). LTG was added to other AEDs in a study of adjunctive therapy. Patients were evaluated for changes in mood states with the Profile of Mood States (POMS) and QOLIE-31 at baseline, after addition of LTG as adjunctive treatment, and after withdrawal of other drugs to LTG monotherapy. POMS scores include six subscales (Tension, Depression, Anxiety, Vigor, Fatigue, Confusion) and a total. Physicians[rsquo] ratings of global change were used to determine minimal clinically important changes (MCIC) in POMS scores. POMS scores were clinically and statistically significantly improved with LTG. MCIC changes in POMS scores were: Tension 17%, Depression 38%, Anger 39%, Vigor 21%, Fatigue 25%, Confusion 34%, Total 43%, based on physicians[rsquo] detection of overall patient improvement. Among all patients completing Adjunctive LTG (N=155, effect sizes 0.35-0.65) all scale scores were improved (all p[lt]0.0001). Tension, Vigor and Fatigue subscales met MCIC, with Total scores improving 39% (effect size 0.58). Among patients completing both Adjunctive and Monotherapy LTG (N=51), all POMS scores were statistically improved (P[lt]0.003) with effect sizes 0.48-0.94. Subscale scores at the end of Adjunctive and Monotherapy LTG were: Tension 28, 26%, Depression 36, 37%, Anger 39, 36%, Vigor 31, 43%, Fatigue 36, 42%, Confusion 30, 27%, respectively. Total scores improved 47% (effect size 0.82) at end of Adjunct LTG, and 50% (effect size 0.84) at end on Monotherapy LTG. At the end of monotherapy, all scores remained significantly better than baseline (all p[lt]0.003, effect sizes 0.48-0.94), but none were significantly different from end of the adjunctive phase. POMS scores correlated highly with the QOLIE-31 Emotional Well-Being subscale(r=0.698), a known measure of mood, but not with seizure reduction. POMS score changes were defined as clinically important improvements with the addition of LTG to other AEDs, and withdrawal to monotherapy. The improvements in all measured aspects of mood states likely were not a synergy between LTG and other AEDs because they remained stable after withdrawal of the other AEDs. (Supported by GlaxoSmithKline)