Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| SMHC-101 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Jiangsu Nhwa Pharmaceutical Co., Ltd. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary objective of this study is to evaluate the efficacy and safety of Generic Escitalopram in the treatment of Chinese patients with depression compared with Innovator Escitalopram(Lexapro®) by evaluating the change of HAMD-17 total score from the baseline to week 8.
This is a double-blind, parallel assignment, randomized and innovator controlled study. The subjects investigated are outpatients with major depressive disorder(MDD)according to DSM-IV from the Chinese population. The screening phase lasts for 1 week. The eligible patients enter the next randomized treatment phase. The fixed dose(generic escitalopram 10mg/d or Innovator Escitalopram(Lexapro®) 10mg/d) duration is 2 week. After the first 2 weeks, according to CGI and investigator's assessment the patients are administrated 2 different dose, one is previous dose 10mg/d, the other is high dose 20mg/d. In this study, total duration lasts for 8 weeks.
The efficacy and safety of Innovator Escitalopram(Lexapro®) in the treatment of patients with MDD have been confirmed by multiple double blind studies. This study is designed to evaluate the efficacy and safety of genetic escitalopram in the treatment of Chinese patients with MDD. Therefore, the double blind and innovator control(Lexapro®) design should be selected for this study. The drug titration method and dose are within the range specified in the instruction and patients with MDD are tolerant to the drug in practical clinical treatment.
The purpose of MDD patient treatment is to improve the core symptoms, prevent suicide, alleviate the side reactions caused by the antidepressant, and recover the life functions of patients. Generally, the treatment in the acute phase lasts for 6 to 8 weeks. In this study, the treatment in the acute phase lasts for 8 weeks.
The rating scales used in this study are standard psychiatric rating scales with good validity and are widely used in the study of antidepressants and in the treatment of patients with MDD. The high inter-investigator reliability and repeated measurement reliability of these scales(HAMD,MADRS,HAMA) have been proved by multiple studies. The clinical global impression (CGI) is a simple but convenient global impression scale. It is applicable to any patients treated and studied by the psychiatric department. The VAS-PI(Visual Analog Scale-Pain Intensity) is used to evaluate the reduction in pain intensity,a common symptom of patients with MDD. It has good reliability and validity. The Sheehan Disability Scale (SDS) was developed to assess functional impairment in three inter-related domains; work/school, social and family life.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Generic Escitalopram Oxalate Tablets |
|
| 2 | Active Comparator | Innovator Escitalopram(Lexapro®) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Generic Escitalopram | Drug | 10mg/d or 20mg/d |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| the change of HAMD-17 total score | from the baseline to week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| the change of MADRS total score | from the baseline to week 8 | |
| the change of HAMA total score | from the baseline to week 8 | |
| the clinical global impression (CGI),including CGI-I and CGI-S |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Huafang LI, MD,PhD | Drug Clinical Trial Office, Shanghai Mental Health Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hebei Mental Health Center | Baoding | Hebei | 071000 | China | ||
| Nanjing Brain Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24991142 | Derived | Yu Y, Li H, Wang B, Li K, Xu X, Shi J, Gao C, Tan Q. Efficacy and safety of generic escitalopram versus Lexapro in the treatment of major depression: a multicenter double-blinded randomized controlled trial. Shanghai Arch Psychiatry. 2013 Apr;25(2):107-15. doi: 10.3969/j.issn.1002-0829.2013.02.007. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003863 | Depression |
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D000089983 | Escitalopram |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D001572 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Innovator Escitalopram | Drug | 10mg/d or 20mg/d |
|
|
| from the baseline to week 8 |
| the change of VAS-PI | from the baseline to Week 8 |
| the change of Sheehan Disability Scale(SDS) | from the baseline to Week 8 |
| Nanjing |
| Jiangsu |
| 210029 |
| China |
| the First Affiliated Hospital,Medical School of Xi'an Jiaotong University | Xi'an | Shaanxi | 710061 | China |
| Xi'an Mental Health Center | Xi'an | Shaanxi | 710061 | China |
| Shanghai Mental Health Center | Shanghai | Shanghai Municipality | 200030 | China |
| The First Affilliated Hospital Of Kunming Medical College | Kunming | Yunnan | 650032 | China |
| D001523 |
| Mental Disorders |
| Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |