Safety and effectiveness of escitalopram in an 8-week open study in Chinese patients with depression and anxiety

Figures & data

Figure 1 Patient disposition.

Notes: N, total sample size; n, total number of patients in a subset.

Table 1 Patient baseline demographics and clinical characteristics (full analysis set)

Variables	(N=241)
Age (years), mean (SD)a	39.0 (12.8)
Weight (kg), mean (SD)b	62.2 (10.9)
Gender (women), n (%)	156.0 (64.7)
Race, n (%)
Han	233.0 (96.7)
Unknown	1.0 (0.4)
Others	7.0 (2.9)
Marital status, n (%)
Married	172.0 (71.4)
Single	53.0 (22.0)
Divorced	10.0 (4.1)
Widowed	6.0 (2.5)
Alprazolam	7 (2.7)
Is there excessive drinking history in the past 12 months?, n (%)
No	241.0 (100.0)
Is there drug abuse history in the last 12 months?, n (%)
No	241.0 (100.0)
SDS total score at baseline, mean (SD)	17.4 (5.9)
Q-LES-Q-SF total score at baseline, mean (SD)	39.3 (14.43)
MADRS total score, mean (SD)	29.1 (6.64)
HAM-A total score, mean (SD)	25.6 (7.01)
QIDS-SR total score, mean (SD)	14.9 (4.29)
QoL, n (%)
Impaired	234 (97.9)
Severely impaired	213 (89.1)

Notes:

a N=240;

b N=239.

Abbreviations: HAM-A, Hamilton Anxiety Scale; MADRS, Montgomery-Åsberg Depression Rating Scale; N, total sample size; n, total number of patients in a subset; QIDS-SR, Quick Inventory of Depressive Symptomatology-Self Report; Q-LES-Q-SF, Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form; QoL, quality of life; SDS, Sheehan Disability Scale.

Table 2 Mean (SD) scores of measurement at baseline and at each visit (full analysis set, last observation carried forward)

Parameters	Baseline	Week 1	Week 2	Week 4	Week 6	Week 8
Q-LES-Q-SF total score	39.3 (14.43)	–	48.8 (14.29)	54.3 (14.76)	58.2 (15.47)	61.6 (15.80)
SDS total score	17.4 (5.9)		12.9 (6.84)	10.6 (6.96)	9.3 (7.06)	7.6 (6.71)
Work	5.9 (2.31)	–	4.4 (2.46)	3.7 (2.48)	3.1 (2.45)	2.6 (2.33)
Social life	6.0 (2.27)	–	4.3 (2.42)	3.5 (2.37)	3.1 (2.39)	2.5 (2.32)
Family life	5.6 (2.30)	–	4.1 (2.49)	3.5 (2.51)	3.0 (2.54)	2.5 (2.42)
MADRS total score	29.1 (6.64)	23.4 (6.80)	18.6 (7.69)	15.5 (8.21)	12.6 (8.31)	10.0 (8.43)
HAM-A total score	25.6 (7.01)	20.0 (8.02)	15.4 (8.15)	12.6 (7.95)	10.4 (7.78)	8.0 (7.42)
QIDS-SR total score	14.9 (4.29)	11.9 (4.56)	10.2 (4.80)	8.8 (4.99)	7.5 (5.05)	6.3 (4.70)

Note: p<0.0001 on the change from baseline for each post-baseline visit (obtained with Wilcoxon signed-rank test).

Abbreviations: HAM-A, Hamilton Anxiety Scale; MADRS, Montgomery-Åsberg Depression Rating Scale; QIDS-SR, Quick Inventory of Depressive Symptomatology-Self Report; Q-LES-Q-SF, Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form; SD, standard deviation; SDS, Sheehan Disability Scale.

Table 3 Multiple linear regression analyses of baseline SDS total score

Variables	Coefficient	p-value
Baseline score of Q-LES-Q-SF	0.02758	0.3575
Baseline score of MADRS	0.20952	0.0084
Baseline score of QIDS-SR	0.40582	0.0005
Baseline score of HAM-A	−0.00926	0.8737

Notes: Baseline SDS score was considered as a dependent variable; multiple linear regression analyses were performed on baseline MADRS score, QIDS score, and HAM-A score.

Abbreviations: HAM-A, Hamilton Anxiety Scale; MADRS, Montgomery-Åsberg Depression Rating Scale; QIDS-SR, Quick Inventory of Depressive Symptomatology-Self Report; Q-LES-Q-SF, Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form; SDS, Sheehan Disability Scale.

Table 4 Multiple logistic regression analyses of impact factors of SDS remission at end point

Variables	OR	Lower limit of 95% CI	Upper limit of 95% CI	p-value
Single-factor logistic analysis
Baseline Q-LES-Q-SF score	0.992	0.974	1.011	0.4205
Baseline MADRS score	0.968	0.929	1.008	0.1187
Baseline QIDS-SR score	0.953	0.895	1.015	0.1362
Baseline HAM-A score	0.983	0.946	1.021	0.3696
Whether “live with family” (yes, n=109/180 vs no, n=26/48)	1.299	0.684	2.468	0.4242
Change of MADRS at week 2	0.964	0.951	0.978	<0.0001
Change of MADRS at week 6	0.930	0.912	0.947	<0.0001
Change of MADRS at week 8	0.930	0.912	0.947	<0.0001
Change of HAM-A at week 2	0.962	0.949	0.975	<0.0001
Change of HAM-A at week 6	0.934	0.917	0.951	<0.0001
Change of HAM-A at week 8	0.932	0.914	0.951	<0.0001
Multiple-factors logistic analysis
Change of MADRS at week 8	0.951	0.930	0.972	<0.0001
Change of HAM-A at week 2	0.984	0.968	1.000	0.0446
Change of HAM-A at week 6	0.967	0.945	0.990	0.0001

Notes: Remission at end point (SDS≤6 vs SDS>6) was considered as a dependent factor; baseline depression, anxiety, quality of life, “live with family” status, the reduction of MADRS and HAM-A at each visit as covariables; impact factors of SDS remission was selected by single-factor logistic analysis using a stepwise selection process and then validated by multiple-factors logistic analysis.

Abbreviations: CI, confidence interval; HAM-A, Hamilton Anxiety Scale; MADRS, Montgomery-Åsberg Depression Rating Scale; OR, odds ratio; QIDS-SR, Quick Inventory of Depressive Symptomatology-Self Report; Q-LES-Q-SF, Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form; SDS, Sheehan Disability Scale.

Figure 2 MADRS response and remission rate (full analysis set, last observation carried forward).

Notes: Response: ≥50% improvement from baseline; remission: MADRS total score ≤10.
Abbreviations: LOCF, last observation carried forward; MADRS, Montgomery-Åsberg Depression Rating Scale.

Table 5 Association between the change from baseline to week 8 in SDS total score and MADRS total score and HAM-A total score at each visit (full analysis set, last observation carried forward)

	n	Correlation coefficient	p-value
SDS total score and MADRS total score
Visit (week)
2	216	0.4396	<0.0001
4	225	0.5358
6	225	0.5483
8	225	0.5188
SDS total score and HAM-A total score
Visit (week)
2	216	0.2989	<0.0001
4	225	0.4332
6	225	0.4918
8	225	0.4683

Note: Correlation coefficients were calculated according to Spearman rank correlation.

Abbreviations: HAM-A, Hamilton Anxiety Scale; MADRS, Montgomery-Åsberg Depression Rating Scale; n, total number of patients in a subset; SDS, Sheehan Disability Scale.