James M. Miller, PharmD, lead clinical development scientist, Neurosciences Medicine Development Centre, GlaxoSmithKline, Research Triangle Park, North Carolina, presented the findings on May 9^th.

Depressive complaints are prevalent in up to 55% of people with epilepsy across all age groups, with almost 30% meeting criteria for major depressive disorder, Dr. Miller said. The depression may be caused by the primary antiepileptic agent or by the epilepsy itself, he explained.

Lamotrigine is approved in the U.S. for treatment of bipolar disorder. The use of lamotrigine for this indication and numerous case reports of mood elevation in patients taking the drug for epilepsy led the Dr. Miller and colleagues to design an evaluation in a subset of women with epilepsy who exhibited at least minimal depressive symptoms on a depression screening tool.

In their multicenter, open-label study, lamotrigine was added to a stable antiepileptic drug regimen in an adjunctive phase and became a single agent in a monotherapy phase. Background antiepileptic drugs were phenytoin (26%), carbamazepine (19%), valproic acid (15%), oxcarbazepine (13%) and topiramate (9%).

The researchers evaluated 102 women with a mean age of 38.6 years and baseline questionnaire scores indicating moderate depression. Sixty-six women completed the adjunctive phase and 46 the monotherapy phase.

Treatment consisted of an adjunctive target dose of lamotrigine of 200 mg daily with an enzyme-inhibiting antiepileptic drug, 4009 mg daily with enzyme-inducing antiepileptic drug, or 300 mg daily with other antiepileptic drugs. The lamotrigine monotherapy target dose was 500 mg daily.

Questionnaire scores improved following lamotrigine therapy from indicating moderate depression to mild/minimal depression. All change scores from baseline were highly significant at P <.0001.

The most common adverse events were headache, dizziness, nausea, insomnia and back pain. Discontinuations from the study due to adverse events occurred in 21% of patients. No cases of serious rash were reported.

Dr. Miller said that more than half of patients with epilepsy experience symptoms of depression, and neurologists focus mainly on their seizures. He urged neurologists to inquire about mood as well.


[Presentation title: An Evaluation of Lamotrigine on Mood in Women With Epilepsy and Comorbid Depressive Symptoms. Abstract p. 45S]

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