Lamotrigine Monotherapy Improves Mood in Epilepsy: A Randomized, Double-Blind Comparison with Valproate
Abstract number :
2.060
Submission category :
Year :
2000
Submission ID :
2442
Source :
www.aesnet.org
Presentation date :
12/2/2000 12:00:00 AM
Published date :
Dec 1, 2000, 06:00 AM
Authors :
Keith Edwards, Dalma Kalogjera-Sackellares, Chris Sackellares, Alain Vuong, Anne E Hammer, Pamela S Barrett, Neurological Consultants, PC, Bennington, VT; DVA Medical Ctr, Gainesville, FL; Glaxo Wellcome Inc, RTP, NC.
RATIONALE: In patients with epilepsy, depressive symptoms are underrecognized and may interfere with social functioning. LAMICTAL? (LTG) has been shown to be an effective treatment for the depressive phase of bipolar illness. In some trials LTG was observed to enhance mood, social interaction and well-being in patients with epilepsy. The effects of LTG monotherapy on affective symptoms have not been tested in controlled trials in epilepsy. METHODS: In a trial comparing the effects of LTG to DEPAKOTE? (VPA) on weight gain, mood assessments (Beck Depression Inventory, BDI; Cornell Dysthymia Rating Scale-Self Report, CDRS; Profile of Mood States, POMS) were added as secondary measures. Patients were ?12 yrs with new onset partial or generalized seizures. Patients who had used LTG or VPA for >90 days prior to screen were excluded. Patients were randomized 1:1 to LTG or VPA, entered an 8 week escalation, then a 24 week maintenance phase. The target doses were 200-500 mg/day for LTG, 20-60 mg/kg/day for VPA based on clinical response. RESULTS: LTG group: n=65, 42% male, mean age 35 yrs. VPA group: n=68, 46% male, mean age 30 yrs. The mean dose was 254 mg/day for LTG, 1822 mg/day for VPA. Mean screen BDI scores showed comparable mild depressive symptoms in both groups (10.4 for LTG, 11.9 for VPA); greater score improvements were noted at weeks 10 and 32 with LTG (2.2, 2.6) than with VPA (-0.1, 0.7). Mean screen CDRS scores were similar in both groups (51.7 for LTG, 52.9 for VPA); greater score improvements were observed with LTG (1.4, 3.6) than with VPA (-0.3, 0.5) at weeks 10 and 32. Mean screen POMS scores were also comparable in both groups for all domains, with 36.5 for LTG and 35.8 for VPA for Total Mood Disturbance; at week 32 a greater score improvement was noted for LTG (13.8) than for VPA (-0.4). The mean screen weight was 155 lb for LTG, 161 lb for VPA. The mean weight gain at weeks 10 and 32 was negligible with LTG (1.4, 1.3 lb), and significantly higher (p?0.002) with VPA (5.8, 12.8 lb). CONCLUSIONS: The data suggest that LTG has mood elevating effects in mildly depressed patients with epilepsy, and can be useful in patients with epilepsy and comorbid depressive symptoms.