EFFECTS OF LAMOTRIGINE ON MOOD IN ADULT PATIENTS WITH GENERALIZED TONIC-CLONIC SEIZURES
Abstract number :
2.247
Submission category :
Year :
2005
Submission ID :
5553
Source :
www.aesnet.org
Presentation date :
12/3/2005 12:00:00 AM
Published date :
Dec 2, 2005, 06:00 AM
Authors :
1Alan B. Ettinger, 2Robert P. Kustra, 3Anne E. Hammer, and 2John A. Messenheimer
Mood is strongly associated with quality of life in patients with epilepsy. Lamotrigine (LAMICTAL[reg], LTG) has previously shown positive effects on mood in patients with partial seizures. This analysis examined mood data from a larger study evaluating the safety and efficacy of LTG in patients with generalized seizures. Lamotrigine-na[iuml]ve patients with inadequately controlled generalized tonic-clonic seizures were enrolled in a randomized, double-blind, placebo-controlled trial. Lamotrigine or placebo was titrated according to background anti-epileptic drugs (AED) at baseline, consistent with current dosing recommendations. All adult patients completed three mood questionnaires, the Beck Depression Inventory (BDI), the Profile of Mood States (POMS) and the Cornell Dysthymia Rating Scale (CDRS) at baseline and end of 19 weeks of treatment. Change scores were compared with ANOVA. One hundred seventeen (117) patients were randomized and received LTG or PBO. Efficacy results showed a significant reduction of PGTC seizures with LTG. The median reduction in PGTC seizures during maintenance treatment was 82% for LTG and 43% for PBO, p = 0.006. The mood subanalysis included 81 adult patients, 42 and 39 for LTG and PBO, respectively. The two groups were similar in demography. Mean baseline mood scores for the LTG and PBO groups, respectively, were comparable: 18.3 and 16.8 on BDI; 53.9 and 57.9 on POMS; and 61.1 and 60.8 on CDRS. After treatment, mean improvement in mood scores for the LTG and PBO groups, respectively, were 8.9 and 1.7 points, p=0.01 for BDI; 32 and 6.5 points, p=0.03 for POMS; and 7.3 and 4.1 points, p=NS for CDRS. Improvement in mood was not related to improvement in seizure control (Spearman correlation = 0.25). The most common drug-related adverse events were dizziness (5% LTG and 2% PBO), somnolence (5% LTG and 2% PBO), nausea (5% LTG and 3% PBO). Lamotrigine, a broad spectrum AED, was well tolerated and associated with improved mood scores versus placebo in adult patients with generalized tonic-clonic seizures. (Supported by GlaxoSmithKline Research and Development.)