Prospective, open-label trial measuring satisfaction and convenience of two formulations of lamotrigine in subjects with mood disorders

Figures & data

Table 1 Demographic characteristics and baseline information on disease (ITT population)

	ITT population n = 97
Age, years
Mean (SD)	41.0 (12.07)
Median (range)	40.0 (18–77)
Age group, n (%)
<55 years	83 (86)
≥55 years	14 (14)
Female, n (%)	83 (86)
Age group by gender, n (%)
Female < 55 years	72 (74)
Female ≥ 55 years	11 (11)
Male < 55 years	11 (11)
Male ≥ 55 years	3 (3)
Age, years
Mean (SD)	41.0 (12.07)
Median (range)	40.0 (18–77)
Baseline score CGI-S, n (%)
1	23 (24)
2	35 (36)
3	34 (35)
4	3 (3)
5	2 (2)

Abbreviations: ITT, intention to treat; SD, standard deviation; CGI-S, Clinical Global Impression severity index.

Figure 1 Comparison of response rate to question 9 (ease of use) on the TSQM questionnaire.

Notes: Responses were determined at baseline for the lamotrigine immediate-release formulation (n = 97) and at the end of treatment on day 21 for the lamotrigine ODT formulation (n = 95).
Abbreviations: TSQM, Treatment Satisfaction Questionnaire for Medication; ODT, orally disintegrating tablet; IR, immediate-release.

Table 2 TSQM subscale scores at baseline and endpoint

TSQM subscale	Baseline, mean (SD)a	Endpoint, mean (SD)b	Sign test P value	Two sided t-test P value
Convenience	59.8 (17.53)	83.0 (16.92)	<0.001	<0.001
Global satisfaction	76.3 (16.32)	76.0 (25.63)	0.060	0.921
Effectiveness	73.8 (16.49)	71.1 (24.98)	0.434	0.348
Side effects	90.0 (17.50)	89.8 (23.41)	0.458	0.605

Notes:

a Lamotrigine immediate-release;

b lamotrigine orally disintegrating tablet. For the side effects subscale, not all patients provided responses. The baseline mean in the table is from 81 subjects, the endpoint mean is from 88 subjects, and the P Values are from the 74 subjects with both the baseline and the endpoint. Mean change for these 74 was 1.5.

Abbreviations: SD, standard deviation; TSQM, Treatment Satisfaction Questionnaire for Medication.