Efficacy and tolerability of escitalopram in treatment of major depressive disorder with anxiety symptoms: a 24-week, open-label, prospective study in Chinese population

Figures & data

Figure 1 Patients’ disposition.

Abbreviations: N, total sample size; n, total number of patients in a subset; TEAE, treatment-emergent adverse event.

Table 1 Patients’ demographic and baseline characteristics (full analysis set)

Parameters	N=285
Age, years
Mean (SD)	40.5 (±13.33)
Sex, n (%)
Women	160 (56.1)
Duration of MDD, months
Mean (SD)	52.3 (±74.28)
Duration of current episode, months
Mean (SD)	8.9 (±24.73)*
First episode or recurrence, n (%)
First episode	126 (44.2)
Recurrence	159 (55.8)

Note:

* n=282.

Abbreviations: MDD, major depressive disorder; n, total number of patients in a subset; N, total sample size; SD, standard deviation.

Figure 2 Remission rate by visit based on baseline (A) anxiety level and (B) depression level (full analysis set, LOCF).

Abbreviations: HAM-A, Hamilton Anxiety Rating Scale; LOCF, last observation carried forward; MADRS, Montgomery–Asberg Depression Rating Scale.

Table 2 Summary of efficacy assessments by visit (full analysis set, LOCF)

Parameters	Baseline	Week 8	Week 24	P-value
	Mean (SD)
MADRS total score	33.4 (±7.13)	11.7 (±10.07)	6.6 (±10.18)	<0.0001
HAM-A total score	27.6 (±7.26)	10.6 (±8.65)	6.0 (±8.39)	<0.0001
Somatic anxiety score	16.7 (±3.66)	6.7 (±4.93)	3.7 (±4.99)	<0.0001
Psychic anxiety score	11.0 (±4.68)	4.0 (±4.14)	2.3 (±3.69)	<0.0001
HAM-D-17 total score	27.5 (±5.91)	10.7 (±8.20)	6.3 (±8.25)	<0.0001
Anxiety/somatic factor	8.0 (±2.65)	3.3 (±2.78)	1.9 (±2.54)	<0.0001
Retarded factor (functional impairment)	8.7 (±1.72)	3.8 (±2.61)	2.1 (±2.78)	<0.0001
Sleep disorders	4.3 (±1.61)	1.7 (±1.62)	1.1 (±1.51)	<0.0001
CGI-S score	5.0 (±0.82)	2.9 (±1.18)	2.1 (±1.31)	0.002
CGI-I score	NA	2.1 (±0.97)	1.8 (±1.03)	NA
SF-12 PCS score	−19.96 (±7.42)	−14.15 (±7.67)	−10.6 (±8.74)	<0.0001
SF-12 MCS score	−36.3 (±6.97)	−23.7 (±10.70)	−17.5 (±12.65)	<0.0001

Abbreviations: CGI-I, Clinical Global Impression-Improvement; CGI-S, Clinical Global Impression-Severity; HAM-A, Hamilton Anxiety Rating Scale; HAM-D, Hamilton Depression Rating Scale; LOCF, last observation carried forward; MADRS, Montgomery–Asberg Depression Rating Scale; MCS, mental component score; NA, not available; PCS, physical component score; SD, standard deviation; SF-12, Short Form-12 Scale.

Figure 3 Mean CGI-severity scores by visit after treatment with escitalopram 10–20 mg/day (full analysis set, LOCF).

Abbreviations: CGI, Clinical Global Impression; LOCF, last observation carried forward.

Table 3 Summary of TEAEs in >2 patients (safety set)

Treatment-emergent adverse events, n (%)	Total (N=302)
Headache	12 (3.97)
Nasopharyngitis	11 (3.64)
Nausea	9 (2.98)
Dizziness	8 (2.65)
Abdominal discomfort	5 (1.66)
Diarrhea	4 (1.32)
Insomnia	4 (1.32)
Dysphoria	3 (0.99)
Anxiety	3 (0.99)
Weight gain	3 (0.99)
Transaminase increased	3 (0.99)
Lassitude	3 (0.99)

Abbreviations: N, total sample size; n, number of occurrence of TEAEs; TEAE, treatment-emergent adverse event.

Figure S1 Mean (SD) reduction in (A) MADRS total scores and (B) HAM-A total scores during 24-week treatment period (full analysis set).

Abbreviations: HAM-A, Hamilton Anxiety Rating Scale; MADRS, Montgomery–Asberg Depression Rating Scale; SD, standard deviation.

Figure S2 Mean scores of individual (A) MADRS and (B) HAM-A single items at baseline and week 24 (full analysis set).

Abbreviations: HAM-A, Hamilton Anxiety Rating Scale; MADRS, Montgomery–Asberg Rating Scale.

Table S1 Study sites and patients enrolled

Study site	Safety set, n (%)
Nanjing Drum Tower Hospital, Nanjing	26 (8.61)
Wuhan Mental Health Center	34 (11.26)
Shengjing Hospital, Shenyang	13 (4.30)
The People’s Hospital of Jiangsu Province, Nanjing	6 (1.99)
Shanghai Mental Health Center, Shanghai	45 (14.90)
Tianjing Anding Hospital, Tianjin	20 (6.62)
Hangzhou the 7th Hospital, Hangzhou	33 (10.93)
Beijing University 1st Hospital, Beijing City	34 (11.26)
Nanjing Brain Hospital, Nanjing	19 (6.29)
The Second Xiangya Hospital	38 (12.58)
First affiliated Hospital of Wenzhou Medical University, Wenzhou	25 (8.28)
Beijing University 1st Hospital, Beijing City	9 (2.98)
Beijing Chaoyang hospital	0 (0.0)
Total	302 (100.0)

Abbreviation: n, total number of patients in a subset.