Long-term administration of escitalopram in patients with social anxiety disorder in Japan

Figures & data

Figure 1 Flow chart of patient disposition.

Note: ^aMultiple answers may be given for reason for withdrawal.

Table 1 Demographic and other baseline characteristics (APTS, n=158)

Item	Category	Total (158 patients)
Sex
Number of patients (%)	Male	79 (50.0)
	Female	79 (50.0)
Age (years)
Mean ± SD		33.3±10.8
Body weight (kg)
Mean ± SD		60.1±13.0
BMI (kg/m^2)
Mean ± SD		22.2±4.0
CYP2C19 genotype
Number of patients (%)	EM	137 (86.7)
	PM	21 (13.3)
Age at SAD onset (years)
Mean ± SD		19.0±9.7
Duration of SAD (years)
Mean ± SD		14.3±12.0
Total LSAS-J score
Mean ± SD		95.3±19.5
Median		94.0
Minimum–maximum		60–144
Total SATS score
Mean ± SD		23.7±6.9
Median		22.5
Minimum–maximum		11–42
CGI-S
Mean ± SD		4.9±0.9
Median		5.0
Minimum–maximum		4–7
Total SDISS score
Mean ± SD		11.1±6.6
Median		11.0
Minimum–maximum		0–30
Total MADRS score
Mean ± SD		4.0±4.0
Median		3.0
Minimum–maximum		0–14

Abbreviations: APTS, all-patients-treated set; BMI, body mass index; CGI-S, Clinical Global Impression – Severity Scale; CYP, cytochrome P450; EM, extensive metabolizer; LSAS-J, Liebowitz Social Anxiety Scale – Japanese Version; MADRS, Montgomery Åsberg Depression Rating Scale; PM, poor metabolizer; SAD, social anxiety disorder; SATS, Social Anxiety/Taijin-Kyofu Scale; SD, standard deviation; SDISS, the Japanese version of Sheehan Disability Scale.

Table 2 Adverse drug reactions by period of onset (incidence of ≥2% in treatment period)

Preferred terma	Adverse drug reactions
	Overall		Until week 12		Weeks 13–24		Weeks 25–36		Weeks 37–48		Week 49 onwards
	(158 patients)		(158 patients)		(141 patients)		(137 patients)		(133 patients)		(128 patients)
	(79 males/79 females)		(79 males/79 females)		(72 males/69 females)		(69 males/68 females)		(67 males/66 females)		(65 males/63 females)
	Number of patients	Incidence (%)	Number of patients	Incidence (%)	Number of patients	Incidence (%)	Number of patients	Incidence (%)	Number of patients	Incidence (%)	Number of patients	Incidence (%)
Overall	91	(57.6)	83	(52.5)	15	(10.6)	8	(5.8)	6	(4.5)	4	(3.1)
Somnolence	39	(24.7)	34	(21.5)	5	(3.5)	0		0		0
Nausea	30	(19.0)	29	(18.4)	3	(2.1)	0		0		0
Headache	8	(5.1)	5	(3.2)	1	(0.7)	2	(1.5)	1	(0.8)	1	(0.8)
Malaise	8	(5.1)	8	(5.1)	0		0		0		0
Diarrhea	7	(4.4)	5	(3.2)	1	(0.7)	0		1	(0.8)	0
Abdominal discomfort	6	(3.8)	5	(3.2)	1	(0.7)	0		1	(0.8)	0
Abdominal pain upper	6	(3.8)	5	(3.2)	1	(0.7)	0		1	(0.8)	0
Ejaculation disorder^b	3	(3.8)	3	(3.8)	0		0		0		0
Thirst	6	(3.8)	6	(3.8)	1	(0.7)	0		0		0
Insomnia	4	(2.5)	4	(2.5)	0		0		0		0
Initial insomnia	4	(2.5)	4	(2.5)	0		0		0		0

Notes:

a Dictionary: MedDRAVer.16.0. bMale subjects only.

Abbreviation: MedDRA, Medical Dictionary for Regulatory Activities.

Table 3 Summary of efficacy evaluation (FAS)

	Baseline (158 patients)	Week 12 (141 patients)	Week 24 (138 patients)	Week 52 (126 patients)
LSAS-J total score	95.3±19.5	69.0±25.1	59.9±28.7	49.9±28.0
Change	–	−26.6±21.5	−35.6±27.2	−44.8±28.8
SATS total score	23.7±6.9	18.3±8.0	15.9±8.9	12.5±8.7
Change	–	−5.4±5.7	−7.7±6.7	−11.2±7.6
SATS total score (no cognitive symptoms)a	20.6±5.0	15.6±6.8	13.1±7.3	10.0±6.6
Change	–	−5.3±5.0	−7.7±6.2	−10.7±6.2
SATS total score (with cognitive symptoms)b	27.9±6.9	22.1±8.0	20.1±9.6	16.0±10.1
Change	–	−5.6±6.5	−7.8±7.6	−12.0±9.2
CGI-S	4.9±0.9	3.8±1.0	3.3±1.1	2.7±1.1
Change	–	−1.1±1.1	−1.6±1.3	−2.2±1.3
CGI-I	–	2.8±1.0	2.4±1.0	1.9±0.9
SDISS (work/school)	4.5±2.6	3.1±2.4	2.8±2.4	2.2±2.2
Change	–	−1.3±2.3	−1.6±2.6	−2.2±2.6
SDISS (social life)	4.0±2.5	2.8±2.1	2.6±2.2	2.0±2.0
Change	–	−1.1±2.1	−1.3±2.4	−1.9±2.4
SDISS (communication and role at home)	2.6±2.6	1.9±2.1	1.7±2.1	1.6±1.9
Change	–	−0.6±1.9	−0.8±2.3	−0.9±2.2

Notes: Data presented as mean ± SD.

a Baseline: 92 patients, week 12: 83 patients, week 24: 82 patients, week 52: 74 patients.

b Baseline: 66 patients, week 12: 58 patients, week 24: 56 patients, week 52: 52 patients.

Abbreviations: CGI-I, Clinical Global Impression – Improvement Scale; CGI-S, Clinical Global Impression – Severity Scale; FAS, full analysis set; LSAS-J, Liebowitz Social Anxiety Scale – Japanese Version; SATS, Social Anxiety/Taijin-Kyofu Scale; SD, standard deviation; SDISS, the Japanese version of Sheehan Disability Scale.

Figure 2 Estimated change in the Japanese version of the LSAS-J total scores from baseline to week 52 (FAS, OC by visit) and FAS, LOCF at last assessment.

Note: Patient numbers at each visit are shown below the x-axis.
Abbreviations: FAS, full-analysis set; LOCF, last observation carried forward; LSAS-J, Liebowitz Social Anxiety Scale – Japanese Version; OC, observed cases.