LAMOTRIGINE MONOTHERAPY IMPROVES MOOD IN ADOLESCENTS WITH EPILEPSY: A RANDOMIZED, DOUBLE-BLIND COMPARISON WITH VALPROATE
Abstract number :
2.492
Submission category :
Year :
2004
Submission ID :
4941
Source :
www.aesnet.org
Presentation date :
12/2/2004 12:00:00 AM
Published date :
Dec 1, 2004, 06:00 AM
Authors :
1Chris Sackellares, 2Alain Vuong, and 2Anne Hammer
In adolescents with epilepsy depressive symptoms are underrecognized and may interfere with education and social functioning. Lamotrigine (LTG) has been shown to be an effective maintenance treatment for bipolar disorder, with robust efficacy in the depressive phase. LTG was noted to enhance patients[rsquo] mood and well-being in patients with epilepsy. The effects of LTG monotherapy on affective symptoms have not been tested in controlled trials in adolescents with epilepsy. In a trial comparing the effects of LTG (LAMICTAL[reg] ) to valproate (VPA, DEPAKOTE[reg] ) 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 [ge]12 yrs with new onset partial or generalized seizures. Patients who had used LTG or VPA for [gt]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. Results are reported here for patients 12-20 years old, the CDC definition of adolescents. LTG group: n=18, 33% male, mean age 16 yrs. VPA group: n=20, 45% male, mean age 16 yrs. The mean maintenance dose was 261 mg/day for LTG, 1510 mg/day for VPA. Mean baseline BDI scores showed comparable mild depressive symptoms in both groups (6.2 for LTG, 9.6 for VPA); greater score improvements were noted at weeks 10 and 32 with LTG (1.5, 2.7) than with VPA (0, 0.4). Mean baseline CDRS scores were similar in both groups (44.4 for LTG, 50.4 for VPA); greater score improvements were observed with LTG (2.1) than with VPA (-0.5) at week 32. Mean baseline POMS scores were also comparable in both groups for all domains, with 24.9 for LTG and 30.6 for VPA for Total Mood Disturbance; at week 32 a greater score improvement was noted for LTG (12.7) than for VPA (5.0). The mean screen weights were 141 lb for both LTG and VPA. The mean weight gain at weeks 10 and 32 was negligible with LTG (1.8, 1.1 lb), and significantly higher (p[lt]0.05) with VPA (7.0, 15.4 lb). Seizure control was similar in the two treatment groups (Biton et al., J. Child. Neurol. 18(2):133-139, 2003). The data suggest that LTG has mood elevating effects in mildly depressed adolescents with epilepsy, and can be useful in adolescents with epilepsy and comorbid depressive symptoms without causing weight gain. (Supported by GlaxoSmithKline.)