Improvement in Comorbid Depression in Patients with Complex Partial Seizures Treated with Lamotrigine.
Abstract number :
2.248
Submission category :
Year :
2001
Submission ID :
142
Source :
www.aesnet.org
Presentation date :
12/1/2001 12:00:00 AM
Published date :
Dec 1, 2001, 06:00 AM
Authors :
D. Kalogjera-Sackellares, Ph.D., Neuroscience, University of Florida and Malcolm Randall VAMC, Gainesville, FL; J.C. Sackellares, M.D., Neuroscience and Neurology, University of Florida and Malcolm Randall VAMC, Gainesville, FL
RATIONALE: Given the prevalence of depressive symptoms among patients with epilepsy, an anticonvulsant drug with antidepressant effects would be highly desirable. Previous studies have demonstrated improvement in mood, including depressive symptoms, in patients treated with lamotrigine. The present study was undertaken to test the hypothesis that patients with complex partial seizures and comorbid depression would experience improvement in depression after initiation of lamotrigine.
METHODS: Eleven patients, ages 21 to 55 years with complex partial seizures, with or without secondary generalization, and clinical evidence of mild depression were evaluated. Patients taking more than 2 anticonvulsant drugs, having a progressive neurological disorder, mental retardation, history of drug or alcohol abuse in the past 2 years, and pregnant women were excluded from the study. The Montgomery and Asberg Depression Rating Scale (MADRS) was administered at baseline (within 2 weeks of starting lamotrigine), and 5 weeks and 3 months after initiating open-label lamotrigine. Lamotrigine was initiated at 25 mg bid and gradually increased, as tolerated, up to 250 mg bid, except in patients who were not receiving enzyme AED[ssquote]s, where the initial dose was 25 mg q.o.d, with more gradual dose escalation. Scores on the Apparent Sadness (ASAD) and Reported Sadness (RSAD) subscales, as well as the Overall MADRS Score (OS) were evaluated to test the hypothesis that these scores would be lower than baseline at the week 5 and month 3 evaluations. The Wilcoxon signed-rank test was used to determine statistical significance.
RESULTS: Ten patients completed the study. One withdrew because of a mild rash in the 2nd week of treatment. The mean dose of lamotrigine was 142.5[plusminus]55.3 mg (plasma level 2.43[plusminus]1.0 mcg/ml) at 5 weeks and 392.5[plusminus]140.5 mg (plasma level 6.5[plusminus]2.7 mcg/ml) at 3 months. Side effects (nausea, dizziness, and fatigue) were transient or responded to dose reduction. At baseline, mean and standard deviation scores on ASAD, RSAD, and OS were 1.50[plusminus]0.53, 2.10[plusminus]0.74, 18.40[plusminus]3.24, respectively. Relative to baseline, these scores were significantly lower at the 5-week evaluation (ASAD = 0.50[plusminus]0.71, p= 0.006; RSAD = 1.20[plusminus]0.63, p = 0.006; OS = 13.10[plusminus]3.38, p = 0.003) and at the 3-month evaluation (ASAD = 0.60[plusminus]0.70, p= 0.009; RSAD = 1.50[plusminus]0.71, p = 0.027; OS = 14.10[plusminus]5.70, p = 0.018), indicating clinical improvement.
CONCLUSIONS: The results of this open-label study indicate that lamotrigine may improve the depression associated with complex partial seizures. Placebo-controlled trials are warranted to confirm these findings.
Support: Supported in part by Glaxo/Wellcome
Disclosure: Grant - Supported in part by GlaxoWellcome Inc.; Consulting - Dr. Sackellares has served as an ad hoc consultant to GlaxoWellcome Inc.