Efficacy and safety of generic escitalopram (Lexacure^®) in patients with major depressive disorder: a 6-week multicenter, randomized, rater-blinded, escitalopram-comparative, non-inferiority study

Figures & data

Table 1 Demographic data of the generic escitalopram (Lexacure^®) and branded escitalopram (Lexapro^®) groups (ITT)

	Total (N=158)	Lexacure^® (n=78)	Lexapro^® (n=80)	P-value
Age (years, SD)	48.1 (13.5)	48.4 (13.8)	47.6 (13.2)	0.794
Female	112 (70.9%)	56 (71.8%)	56 (70.0%)	0.804
Years in education, mean (SD)	11.3 (3.9)	11.3 (3.5)	11.4 (3.9)	0.857
Married	100 (63.3%)	51 (65.4%)	49 (61.3%)	0.877
Inpatient	21 (13.3%)	10 (12.8%)	11 (13.6%)	0.839
Illness duration (months, SD)	44.5 (84.6)	44.4 (84.6)	44.5 (82.2)	0.855
Comorbid medical illness
Hypertension	18 (11.4%)	8 (10.3%)	10 (12.5%)	0.803
Diabetes	10 (6.3%)	4 (5.1%)	6 (7.5%)	0.746
Gastrointestinal disease	10 (6.3%)	5 (6.4%)	5 (6.3%)	1.0
Arthritis	4 (2.5%)	2 (2.6%)	2 (2.5%)	1.0
Dyslipidemia	3 (1.9%)	1 (1.3%)	2 (2.5%)	1.0
Mean dosage at week 6 (mg/day)	16.0 (4.9)	16.6 (4.7)	15.4 (4.9)	0.198
Baseline concomitant medications
Anxiolytics	98 (62.0%)	47 (60.3%)	51 (63.8%)	0.743
Hypnotics	52 (32.9%)	21 (26.9%)	31 (38.8%)	0.130
Baseline score of scales
MADRS	30.8 (5.8)	30.7 (5.9)	30.8 (4.9)	0.914
HDRS	24.2 (5.6)	24.4 (5.6)	24.2 (5.1)	0.797
CGI-S	5.0 (0.8)	5.0 (0.8)	45.0 (0.7)	0.692
Dropout	58 (36.7%)	30 (38.5%)	28 (35.0%)	0.727

Notes: Statistical analyses were conducted with Student’s t-test and chi-square test. The data are presented as mean (SD) or n (%).

Abbreviations: CGI-S, Clinical Global Impressions-Severity scale; HDRS, Hamilton Depression Rating Scale; ITT, intention-to-treat; MADRS, Montgomery–Åsberg Depression Rating Scale; SD, standard deviation.

Figure 1 Changes in MADRS, HDRS, and CGI-S from baseline to week 6 (PP).

Notes: There were no significant differences between the generic escitalopram (Lexacure^®) and branded escitalopram (Lexapro^®) groups according to one-tailed Student’s t-test.
Abbreviations: CGI-S, Clinical Global Impressions-Severity scale; HDRS, Hamilton Depression Rating Scale; MADRS, Montgomery–Åsberg Depression Rating Scale; PP, per protocol.

Table 2 Changes in MADRS scores and comparisons of the generic escitalopram (Lexacure^®) and branded escitalopram (Lexapro^®) groups at each study visit (PP)

	Total (N=101)	Lexacure^® (n=49)	Lexapro^® (n=52)	P-value (one-tailed)
Baseline	30.7 (5.4)	30.7 (5.9)	30.8 (4.9)	0.457
Week 1	23.8 (8.1)	24.2 (8.2)	23.4 (8.0)	0.319
Week 2	18.7 (7.5)	19.4 (8.4)	18.1 (6.6)	0.199
Week 4	14.9 (7.8)	15.8 (8.8)	14.0 (6.9)	0.122
Week 6	12.4 (8.1)	13.5 (8.8)	11.3 (7.3)	0.093
P-value	<0.001*	<0.001*	<0.001*

Notes:

* P<0.001 according to a repeated-measure analysis of variance (ANOVA). There were no significant differences between the Lexacure^® and Lexapro^® groups according to one-tailed Student’s t-test. The data are presented as mean (SD).

Abbreviations: PP, per protocol; MADRS, Montgomery–Åsberg Depression Rating Scale.

Figure 2 Comparisons of response and remission rates between the generic escitalopram (Lexacure^®) and branded escitalopram (Lexapro^®) groups (PP).

Notes: (A) Response rates according to MADRS and HDRS scores. (B) Remission rates according to MADRS, HDRS, and CGI-I scores. There were no significant differences between the generic escitalopram and branded escitalopram groups according to one-tailed chi-squared test.
Abbreviations: CGI-I, Clinical Global Impressions–Improvement scale; HDRS, Hamilton Depression Rating Scale; PP, per protocol; MADRS, Montgomery–Åsberg Depression Rating Scale.

Table 3 The presence of adverse events in the generic escita-lopram (Lexacure^®) and branded escitalopram (Lexapro^®) groups (AEs >1.0%; ITT)

	Total (N=158)	Lexacure^® (n=78)	Lexapro^® (n=80)	P-value
Nausea, n (%)	30 (19.0)	14 (17.9)	16 (20.0)	0.714
Sleepiness, n (%)	9 (5.7)	6 (7.7)	3 (3.8)	0.294
Weight gain, n (%)	5 (3.2)	3 (3.8)	2 (2.5)	0.994
Dry mouth, n (%)	4 (2.5)	2 (2.6)	2 (2.5)	0.990
Headache, n (%)	3 (1.9)	3 (3.8)	0 (0)	0.078
Fatigue, n (%)	2 (1.3)	2 (2.6)	0 (0)	0.152
Insomnia, n (%)	2 (1.3)	1 (1.3)	1 (1.3)	0.994
Concentration difficulty,	2 (1.3)	1 (1.3)	1 (1.3)	0.994
n (%)

Note: There were no significant differences between the groups according to Fisher’s exact test.

Abbreviations: AE, adverse events; ITT, intention-to-treat.