Abstracts

Bipolar disorder and medications commonly used in its treatment are associated with cognitive impairment. Cognitive function is more commonly disrupted during mood episodes; there is evidence that patients with bipolar disorder also have cognitive impairment during euthymia. A large controlled, open-label, out-patient study assessed the affect of administering specific dermatological precautions on overall rash rates with lamotrigine. These analyses will describe results from two secondary endpoints: quality of life and cognition. Adult and adolescent subjects ([underline][gt][/underline]13 years old) were administered open-label lamotrigine titrated to a target dosage of 200 mg/day, adjusting for concomitant bipolar medications, and continued for 12 weeks. If on active treatment for bipolar disorder, subjects were to have been on a stable regimen of bipolar medications for at least 2 months prior to entry into to the study. Additionally, this regimen was to remain stable throughout the study period. Subjects were administered the self reported Quality of Life and Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) and the Medical Outcomes Study Cognition Scale (MOS-Cog). These were administered via interactive voice response system (IVRS) at baseline and end of study (week 12). Analysis of these scales were performed using last observation carried forward (LOCF). Although these instruments have been shown to be valid and reliable, the minimal clinically important difference in scores has not been determined. Therefore, we used a criterion of [frac12] standard deviation (SD) of the baseline mean score to determine a clinically meaningful change. 188 sites enrolled 1175 subjects (1135 adults and 40 adolescents). 1139 subjects completed the Q-LES-Q-SF at baseline and 914 at week 12. Mean scores from general activities of life enjoyment questions improved during the 12 weeks of treatment with lamotrigine with a change from baseline score of 10.1 (p[lt]??). 1137 subjects completed the MOS-Cog at baseline and 912 at week 12. Mean scores improved during the 12 week study period with lamotrigine with a change from baseline score of 8.4 (p[lt]??). While subjects[apos] mean scores improved on both instruments, using the [frac12] SD criterion, only the Q-LES-Q-SF scores were clinically meaningful. However, more research is needed with these instruments. Adverse events [underline][gt][/underline] 5% included non-serious rash (9%), headache (8%), dizziness (5%), nausea (5%), and insomnia (5%). No serious rash was reported. In a large out-patient study, self reported quality of life enjoyment and cognitive function scores improved over 12 weeks when lamotrigine was added to current therapy. Lamotrigine was generally well tolerated in this study. (Supported by GlaxoSmithKline.)