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Efficacy and safety of generic escitalopram versus Lexapro in the treatment of major depression: a multicenter double-blinded randomized controlled trial.

1. Introduction

Depression is characterized by high prevalence, frequent relapse, substantial disability, and increased mortality. In both high-income and low- and middle-income countries it is one of the two most important causes of disease burden. [1] The current combined prevalence of major depression and dysthymic disorder among adults in China is 4% representing more than 35 million individuals--but only about 8% of these individuals have ever received any type of treatment for their condition. [2] One of several reasons for the low treatment rates is the relatively high cost of imported proprietary antidepressant medications, so the development of generic forms of antidepressants is an important step in increasing treatment rates for depressive conditions and, thus, reducing the huge health burden these conditions place on the country.

Selective Serotonin Reuptake Inhibitors (SSRIs) are one important category of antidepressants. Escitalopram is an SSRI antidepressant (the S-stereoisomer of citalopram) that has been shown to have good treatment effects with relatively few side effects.1351 The chemical structure and treatment mechanisms of generic escitalopram produced by Jiangsu Nhwa Pharmaceutical Corporation Limited are the same as those of the proprietary form of escitalopram (Lexapro) which is imported and supplied by Xi'an Janssen Pharmaceutica. The average monthly cost of treatment with the generic form of escitalpram is 223 Renminbi (36 US dollars) while that of the proprietary form is 501 Renminbi (81 US dollars). This study is a randomized controlled trial that aims to compare the clinical efficacy and safety of these two forms of escitalopram.

2. Methods

2.1 Sample

The Shanghai Mental Health Center served as the coordinating center for the study and five other psychiatric hospitals from different parts of China participated in the study. Inclusion criteria included: (a) outpatient psychiatric patient at the participating centers with a diagnosis of major depressive disorder based on criteria specified in the Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) [6] (as determined by the treating clinician); (b) between 18 and 65 years of age; (c) not currently taking psychoactive medications other than sleeping medications (those previously taking medications had to be drug-free for at least 7 times the half-life of the medication); (d) Hamilton Depression Rating Scale (HAMD-17) [7] score [greater than or equal to]20 both at the time of screening and at the time of entry into the treatment phase of the study; (e) a score on the first HAMD item (about depressed affect) of [greater than or equal to]2; and (f) a score on the severity subscale of the Clinical Global Impression scale (CGI-S) [8] of [greater than or equal to] 4.

Individuals with any of the following conditions were excluded: (a) serious suicidal ideation based on the clinician's evaluation; (b) any serious physical illness; (c) any history of epilepsy; (d) history of closed-angle glaucoma; (e) abuse of or dependence on alcohol or any psychoactive drug during the past year; (f) depressive episode induced by other mental or physical illnesses; (g) lactation, current pregnancy, or any possible pregnancy during the trial; (h) history of severe drug allergy; or (i) a history of poor response to escitalopram.

The enrollment of subjects is shown in Figure 1. A total of 260 individuals were recruited from March 13 to October 7, 2009 and 130 individuals were randomly assigned to the study group (those using generic escitalopram) or the control group (those using Lexapro). The study group included 46 males and 84 females; their mean (s.d.) age was 37.2 (12.9) years; 37 (28.5%) had a college education; 53 (40.8%) were in their first episode of illness, 58 (44.6%) had had multiple depressive episodes, and 19 (14.6%) had chronic depression; the median (intraquartile range) duration of the current episode of depression and the total duration of depressive episodes were 3 (1 to 4) months and 15 (4 to 48) months, respectively; and 80 (61.5%) reported that 'psychological pressure' was the main precipitant of their current depressive symptoms. The control group included 49 males and 81 females; their mean age was 39.4 (12.8) years; 43 (33.1%) had a college education; 59 (45.4%) were in their first episode of illness, 51 (39.2%) had had multiple depressive episodes, and 20 (15.4%) had chronic depression; the median duration of the current episode of depression and the total duration of depressive episodes were 3 (1 to 6) months and 16 (6 to 55) months, respectively; and 69 (53.1%) reported that psychological pressure was the main precipitant of their current depressive symptoms. No statistically significant differences were found between the groups for sex, age, level of education, duration of current episode, total duration of depressive episodes, type of depressive episode, or reported triggers of the depressive episode. Before treatment, the mean scores on the HAMD-17 were 24.7 (3.2) and 24.7 (3.3) for the study group and control group, respectively (t=0.04; p=0.970).

2.2 Study design

This is a multicenter double-blind randomized controlled trial comparing the efficacy and safety of generic escitalopram and its commercial counterpart, Lexapro, in the treatment of major depressive disorder. At each of the six centers two or three research clinicians were trained in the protocol and in the administration of the evaluative instruments employed in the study. Standard methods were employed to ensure maintenance of blinding; only the study coordinator at each site (who was not involved in the evaluation or treatment of subjects) was able to break the blind during the course of the study. Stratified randomization (stratified by institution) was used to assign participants to the study or the control group using the 'Drug and Statistics' (DAS) software version 2.1.1 (a Chinese statistical package). The total duration of observation was eight weeks. Both generic escitalopram (10 mg/tablet, batch number, 20071001) and Lexapro (10 mg/tablet, batch number, 2163474) were taken orally once a day. (These medications were all provided by the Jiangsu Nhwa Pharmaceutical Corporation Limited.) The initial dosage for both groups was 10 mg/d. At the end of the second week the dosage was increased to 20 mg/d if the patient tolerated the medication well but the treatment effect was considered poor (i.e., a score of [greater than or equal to]3 on the improvement subscale of the Clinical Global Impression scale [CGI-I][8]) or if the treating clinician thought it necessary to increase the dosage. Alternatively, the dosage was maintained at 10 mg/d after two weeks of treatment if the treatment was considered effective (e.g., CGI-I <3), if the treating clinician did not think it necessary to increase the dosage, or if the patient did not tolerate the medication well.

During the trial, sleep medications (e.g., Zolpidem, zopiclone, midazolam, alprazolam, clonazepam, and estazolam) at usual dosages were allowed before the patient went to sleep. The maximum duration of consecutive treatment with sleep medication was one week. No other forms of treatment that could potentially interfere with the treatment outcome were allowed, including antipsychotics, antidepressants, anti-anxiety medications, mood stabilizers, systematic psychological therapy, or electroconvulsive therapy.

Patients were withdrawn from the study if any of the following occurred: (a) patient or family request to withdrawal (usually due to poor treatment effect or severe side effect); (b) discontinuation of medication for at least three consecutive days; (c) loss to follow-up; (d) treating clinician recommends withdrawal from study (usually due to poor compliance or the occurrence adverse events); (e) break of blinding (i.e., treating clinician or patient knows which type of medication is being administered); (f) the occurrence of manic or psychotic symptoms for at least two weeks; (g) the occurrence of a suicide attempt; (h) poor treatment effect or exacerbated symptoms after four weeks of treatment; or (i) pregnancy during the trial.

This study was approved by the institutional review board of the Shanghai Mental Health Center.

2.3 Evaluation of treatment effect and safety

The main index for treatment effect was the change in the HAMD total score at the end of eight weeks of treatment. Clinical remission was considered when the total HAMD score was equal to or less than seven. Treatment was considered effective when there was a 50% or greater reduction in the baseline HAMD total score; treatment was considered ineffective if the HAMD reduction was less than 50%. Secondary outcome measures included the Montgomery-Asberg Depression Scale (MADRS), [9] the Hamilton Anxiety Scale (HAMA),[10] and changes in the CGI score. The validity and reliability of Chinese versions of HAMD, MADRS, and HAMA are satisfactory.[11] These outcomes were assessed by the treating clinician at baseline, and at the end of the 1st, 2nd, 4th, and 8th weeks of treatment (or at the time of termination from the study).

Evaluations of safety included assessment of vital signs and identification of adverse events by asking patients about the occurrence of any physical or psychological changes (whether or not they are related to medication use) at the end of the 1st, 2nd, 4th, 6th and 8th weeks of treatment. Laboratory tests of blood and urine and electrocardiograms were conducted at baseline and at the end of the 8th week of treatment.

2.4 Statistical analysis

The required sample sizes were estimated using standard methods for tests of non-inferiority (equivalence trial). Based on data reported from the company that developed escitalopram, the total HAMD score dropped 12.3 points after eight weeks of treatment. Using 12 as the average required drop in HAMD scores, a [delta] (non-inferiority index) of 2.5, a type I error of 0.025, a type II error of 0.2, and an overall standard deviation in the mean before versus after HAMD change score of 6, the calculated sample size for each group was 90. Considering the requirement of the national Law about the registration of new drugs and potential loss of follow-up, the final sample size was set at 260, 130 in each group.

SAS 9.1.3 was used for all data analysis. Two-sample and one-sample t-tests were used to compare continuous variables and chi-square tests were used to compare categorical variables. Analysis of covariance was used to analyze changes in the main outcome measure (the HAMD-17 total score) after treatment with the center and group assignment as covariates. Repeated measures analysis of variance was used to compare the change in outcome measures between the groups over the five evaluation points (baseline and at the end of the 1st, 2nd, 4th, and 8th weeks of treatment). The Full Analysis Set (FAS) and Safety Set (SS for safety analysis) included all 260 individuals enrolled in the treatment phase of the study; that is, they were 'Intention-to-Treat' (ITT) analyses in which the Last Observation Carried Forward (LOCF) imputation method was used. The Per Protocol Set (PPS) included 210 individuals, including 193 individuals who completed all eight weeks of treatment and 17 individuals who dropped out before completion of eight weeks of treatment but had achieved remision criteria prior to dropping out (their final assessment results were used to impute values at subsequent evaluation periods).

3. Results

3.1 Recruitment and completion

A total of 260 individuals were enrolled in the study with 130 in either arm. There were 35 (26.9%) dropouts in the study group and 32 (24.6%) in the control group ([chi square]=0.18, p=0.671). Figure 1 provides a list of the reasons for dropout in both groups.

3.2 Treatment effect

3.2.1 Changes in the HAMD total score and test ofthe null hypothesis

As shown in Tables 1 and 2, FAS analysis and PPS analysis found no statistically significant differences in the reduction from baseline of the HAMD scores at any of the four follow-up time periods used in the study. The overall time trend analysis also showed no statistically significant difference between the two groups either in the FAS analysis (F=0.44, p=0.664) or in the PPS analysis (F=0.59, p=0.559). The mean difference in the HAMD total scores between the two groups (study group--control group) at week 8 was 0.43 (95% confidence interval [CI]=-1.55, 2.41) for the FAS analysis and 0.43 (95% CI= -0.96, 1.81) for the PPS analysis. As shown in Table 3, after adjusting for baseline HAMD scores and for the six treatment centers using an analysis of covariance, the difference between groups in the HAMD total score at the end of 8 weeks of treatment remained statistically insignificant for both the FAS and PPS analyses. Moreover, the proportion of subjects who reached remission criteria (total HAMD score [less than or equal to]7) and the proportion in which the treatment was considered effective ([greater than or equal to]50% reduction from baseline HAMD score) after 8 weeks of treatment were not significantly different between the two groups: in the FAS analysis, 50.8% (66/130) and 49.2% (64/130) achieved remission in the study and control groups, respectively ([chi square]=0.06, df=1, p=0.804); and in 69.2% (90/130) and 66.9% (87/130) of the study and control group subjects, respectively, the treatment was considered effective ([chi square]=0.16, df=1, p=0.690).

3.2.2 Comparisons of MADRS, HAMA, and CGI-l scores

Analysis of the FAS showed that eight weeks after the beginning of the treatment, the MADRS total score decreased from 30.2 (6.1) at baseline to 8.0 (5.9) in the study group and from 30.9 (6.3) to 8.1 (6.8) in the control group (r=1.12, p=0.902). Similarly, the HAMA score decreased from 21.0 (5.2) at baseline to 6.2 (3.9) in the study group and from 20.4 (5.8) to 6.0 (4.6) in the control group (r=0.43, p=0.669). After 8 weeks of treatment the proportions of 'substantially improved' and 'improved' on the CGI-I were 64.2% and 27.4% in the study group and 66.3% and 24.5% in the control group (r=0.14, p=0.886).

3.3 Safety

3.3.1 Occurrence of adverse events

During the trial 59 (45.4%) individuals in the study group and 74 (56.9%) in the control group experienced one or more adverse events ([chi square]=3A6, p=0.063). Most of these adverse events were mild to moderate in severity and of relatively short duration but in 9 (6.9%) individuals in the study group and 8 (6.2%) individuals in the control group these adverse events were severe enough, persistent enough or distressing enough to require withdrawal from the study ([chi square]=0.06, p=0.802). Four severe adverse events occurred in the study group during the trial (one case of lung cancer, two suicide attempts, and one suicide death) and one severe adverse event occurred in the control group (a suicide death) (Fisher Exact Test p=0.176). In the study group the suicide occurred on the 35th day of treatment and the two suicide attempts occurred on the 2nd day and 20th day of treatment; in the control group the suicide occurred on the 6th day of treatment. Only one of these severe adverse events (the suicide death in the study group) was considered by the treating clinician as possibly related to the use of study medication.

The adverse events with an occurrence of greater than 1% in the study group (i.e., that occurred in at least two different individuals) included dry mouth (12.3 %), nausea (9.2%), dizziness (6.2%), decreased appetite (5.4%), drowsiness (5.4%), fatigue (3.8%), insomnia (3.1%), headache (3.1%), diarrhea (2.3%), heartburn (2.3%), constipation (2.3%), excessive sweating (2.3%), irregular heartbeat (2.3%), pressure in the chest (2.3%), stomach bloating (1.5%), stomach discomfort (1.5%), upper respiratory infection (1.5%), feeling of distention in the head (1.5%), excessive yawning (1.5%), palpitation (1.5%), overall physical discomfort (1.5%), and suicide attempt (1.5%). The majority of adverse events were in the digestive system (37.7%) or the neurological system (27.7%).

In the control group adverse events with an occurrence of greater than 1% included nausea (10.8%), fatigue (7.7%), drowsiness (6.9%), dizziness (5.4%), dry mouth (4.6%), decreased appetite (4.6%), diarrhea (3.8%), constipation (3.8%), headache (3.8%), palpitation (3.8%), discomfort in the stomach (3.1%), upper respiratory infection (2.3%), fainting (2.3%), sleepiness (2.3%), urine track infection (2.3%), abdominal pain (1.5%), insomnia (1.5%), sprain in the right leg (1.5%), delayed urination (1.5%), and formication (1.5%). The majority were events in the digestive (36.2%) or the neurological system (34.6%).

3.3.2 Lab tests, vital signs and physical examinations related to safety

Clinically significant changes in blood and urine tests were identified at the end of the 8th week of treatment in 8 (6.2%) individuals from the study group and 12 (9.2%) from the control group ([chi square]=0.87, p=0.351). In the study group one individual had an elevated white blood count, one had elevated neutrophils, one had urinary leucocytes, two had elevated alanine aminotransferase (ALT), and three had elevated aspartate aminotransferase (AST). In the control group two individuals had and elevated white blood cell count, one had a decreased white blood count, one had elevated neutrophils, one had a low hemoglobin, one had urinary protein, one had white blood cells in the urine, one had elevated ALT, one had elevated AST, and two had elevated fasting blood glucose. No serious physical consequences were observed among study participants who had these changes.

No statistically significant changes or abnormalities in heart rate, in the systolic and diastolic blood pressure, or in the electrocardiogram results were observed during the treatment in either of the groups.

4. Discussion

4.1 Main findings

In this study, the baseline HAMD-17 score was 24, indicating that the majority of patients were moderately to severely depressed. The magnitude of the mean drop in the total HAMD score after 8 weeks of treatment of 13.9 (8.2) in the study group was similar to that found in other studies of escitalopram.[12] The proportions of subjects in whom the treatment was effective (69% in the study group and 67% in the control group) and the proportions who achieved clinical remission (51% in the study group and 49% in the control group) were also in line with the findings of other studies.[13] Our results indicate that both the generic and trade name forms of escitalopram are efficacious antidepressants and that there are no significant differences in the efficacy of the two forms of the medication.

Some studies from other countries have found that escitalopram has a good treatment effect on anxiety symptoms.[14-15] This is supported by findings from the current study. After 8 weeks of treatment, the HAMA score decreased significantly in both groups. The magnitude of the reduction in anxiety symptoms was not significantly different between the two forms of escitalopram.

Common adverse events in both groups were dry mouth, nausea, dizziness, drowsiness and decreased appetite; this pattern of adverse effects is similar to that reported in other studies of escitalopram.[12-16]

The occurrence of four suicidal events (two fatalities and two attempts) in the 260 enrolled subjects (1.5%, 95% CI=0.4, 3.9%) during 8 weeks of treatment despite excluding patients considered at high risk of suicide from the study was concerning. Three of the four suicidal events occurred in the first month of treatment and two of them occurred in the first week of treatment. Suicidal behaviors are rare, but depressed persons are certainly at elevated risk of suicide and there is some evidence that suicidal risk is highest during the first month of antidepressant treatment, so this relatively high rate could be a statistical outlier. [17] Nevertheless, larger studies in which subjects are followed over longer periods are needed to determine whether the rates of suicidal events are higher in those treated with escitalopram than in those treated with other antidepressants. And further efforts are needed to better identify and effectively intervene with the minority of depressed patients who are at high risk of suicide.

A meta-analysis comparing effectiveness and safety of 12 commonly used antidepressants found that generic escitalopram was one of the antidepressants with the best treatment effects and one of the highest rates of treatment adherence. [18] Results from this study confirm this finding in Chinese patients with moderate to severe episodes of major depression who seek treatment in psychiatric outpatient services.

4.2 Limitations

The current study is a multi-center study that enrolled outpatients with depression from six psychiatric hospitals in China. It is unclear how many patients were screened at the centers to identify the 286 potential participants so it is not possible to be certain of the extent to which recruited patients were representative of all depressed individuals in China who receive psychiatric treatment. Moreover, the results could be different in a sample of patients treated at non-specialty hospitals, who typically have less severe forms of depression than those treated at psychiatric hospitals. The sample size, though sufficiently large to assess the main hypothesis about the similarity of the two forms of the medication, was not large enough to conduct stratified analysis (e.g., by gender, age group, number of previous depressive episodes, etc.) so there may be some differences in the outcomes of the two forms of the medication in subgroups of subjects that were not identified. The follow-up period was only 8 weeks, so it is not possible to say anything about the comparability of the two forms of medications during prolonged usage or during the maintenance phase of the treatment of depression. The dropout rate of 27% in the study group and 25% in the control group was relatively high but not out of line with what is seen in similar studies. Additional work is needed to identify biological markers that can identify which patients will respond best to which antidepressants.

4.3 Significance

This study compared the efficacy and safety of generic and brand name escitalopram. In summary, the efficacy and safety of the generic form of escitalopram (produced by Jiangsu Nhwa Pharmaceutical Corporation Limited) during the first 8 weeks of treatment of a depressive episode are not significantly different from the efficacy and safety of the brand name form of escitalopram (Lexapro, produced by Xi'an Janssen Pharmaceutical when used at a dosage of 10 to 20 mg per day in moderate to severely depressed patients treated in the outpatient departments of psychiatric hospitals in China. Both forms of the medication are effective and safe and they are also both relatively effective in alleviating the anxiety symptoms that commonly co- occur with depression. The occurrence of 4 suicidal events (2 deaths and 2 attempts) in the 260 patients (1.5%) treated with escitalopram during the first 35 days of treatment may be a statistical outlier, but the rates of suicidal events should be re-assessed in larger studies with longer follow-up times.

Conflict of interest

The authors report no conflict of interest related to this manuscript.


Funding for this study was received from three sources: (a) the National Science and Technology Major Project for Investigational New Drugs subproject titled 'Clinical Technological Platform for Evaluation of New Drugs in Psychiatry' (CPEP number 2012ZX09303-003); (b) the Shanghai Jiao Tong University School of Medicine 985 Project titled 'Standardized Platform for Clinical Testing of Neuropsychiatric Medications'; and (c) the Jiangsu Nhwa Pharmaceutical Corporation Limited.

doi: 10.3969/j.issn.l002-0829.2013.02.007

(Received: 2012-09-10; Accepted: 2013-01-10)


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Yimin YU (1), Huafang LI (1) *, Biao WANG (1) *, Keqing LI (2), Xiufeng XU (3), Jianguo SHI (4), Chengge GAO (5), Qingrong TAN 6

(1) Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China

(2) Hebei Mental Health Center, Baoding, Hebei Province, China

(3) The First Affiliated Hospital of Kunming Medical College, Kunming, Yunnan Province, China

(4) Xi'an Mental Health Center, Xi'an, Shaanxi Province, China

(5) First Affiliated Hospital of Xi'an, Jiao Tong University Medical College, Xi'an Shaanxi Province, China

(6) Xijing Hospital, Forth Military Medical University, Xi'an, Shaanxi Province, China

* Correspondence: Huafang Li,; Biao Wang,

Dr. Yimin Yu graduated from the Shanghai Second Medical University in 2001 and received a Master's of Medicine degree from the Shanghai Jiao Tong University School of Medicine in 2009. She has worked at the Shanghai Mental Health Center since 2001 and is currently an attending psychiatrist in the Medical Institute for Clinical Trails (MICT) responsible for conducting clinical trials of psychopharmacological agents.

Table 1. Comparison of mean (sd) HAMD-17 total scores between
the groups based on an the Full Analysis Set (FAS) analysis

           Study            Control
           group (generic   group
Time       escitalopram)    (Lexapro)
point      (n =130)         (n =130)      t       P

Baseline   24.7 (3.2)       24.7 (3.3)   0.04   0.970
1 week     21.2 (5.2)       20.6 (5.3)   1.00   0.318
2 week     17.5 (6.6)       17.8 (6.3)   0.37   0.716
4 week     14.3 (7.3)       14.5 (7.0)   0.19   0.849
6 week     12.0 (7.9)       11.9 (7.6)   0.13   0.898
8 week     10.8 (8.4)       10.4 (8.1)   0.41   0.680

           from          reduction
           baseline      from baseline
Time       in study      in control
point      group         group            t       P

Baseline   --            --
1 week     -3.5 (4.0)    -4.1 (4.6)      1.25   0.214
2 week     -7.2 (5.9)    -6.9 (5.8)      0.38   0.701
4 week     -10.4 (6.8)   -10.2 (6.6)     0.19   0.853
6 week     -12.7 (7.7)   -12.8 (7.4)     0.15   0.883
8 week     -13.9 (8.2)   -14.3 (8.1)     0.44   0.664

Table 2. Comparison of mean (sd) HAMD-17 total scores between the
groups based on patients who completed the study according to the
protocol, the Per Protocol Set (PPS)

             Study group     Control
             (generic        group
             escitalopram)   (Lexapro)
Time point   (n =105)        (n =105)     t       P

Baseline     24.6 (3.2)      24.6(3.2)   0.02   0.983
1 week       20.7 (5.0)      19.8(5.3)   1.17   0.242
2 week       16.3 (6.0)      16.6(6.0)   0.31   0.755
4 week       12.1(5.5)       12.4(5.6)   0.38   0.702
6 week       9.3 (5.3)       9.2 (5.2)   0.09   0.926
8 week       7.8 (5.4)       7.3 (5.2)   0.60   0.548

             reduction     reduction
             from          from
             baseline      baseline
             in study      in control
Time point   group         group          t       P

Baseline     --            --
1 week       -4.0 (3.9)    -4.8 (4.7)    1.42   0.158
2 week       -8.3 (5.4)    -8.1 (5.6)    0.33   0.744
4 week       -12.5 (5.1)   -12.2 (5.5)   0.39   0.697
6 week       -15.4 (5.2)   -15.4 (5.5)   0.10   0.918
8 week       -16.8 (5.5)   -17.3 (5.6)   0.59   0.559

Table 3. Analysis of covariance of changes in mean
Hamilton Depression Rating Scale (HAMD-17) total
scores after 8 weeks of treatment using both a
Full Analysis Set (FAS) analysis and a Per
Protocol Set (PPS) analysis

                        FAS analysis            PPS analysis
                   (n=130 in each group)   (n=105 in each group)

Variable           df      F       P         df     F        P

Group assignment    1    0.185   0.667        l    0.365    0.546
Research center     5    0.279   0.924        5    2.075    0.070
Baseline            1    7.089   0.008        1    29.873   <0.001
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Title Annotation:Original article
Author:Yu, Yimin; Li, Huafang; Wang, Biao; Li, Keqing; Xu, Xiufeng; Shi, Jianguo; Gao, Chengge; Tan, Qingro
Publication:Shanghai Archives of Psychiatry
Date:Apr 1, 2013
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