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A multicenter, 10-week study to evaluate the efficacy and safety of Sustained-Release Desvenlafaxine Hydrochloride versus Sustained-Release venlafaxine Hydrochloride in adult with major depressive disorder.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sustained-Release Desvenlafaxine Hydrochloride | Experimental | 50-100mg/d |
|
| Sustained-Release Venlafaxine Hydrochloride | Active Comparator | 75-225mg/d |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sustained-Release Desvenlafaxine Hydrochloride | Drug |
| ||
| Sustained-Release Venlafaxine Hydrochloride |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline on the Hamilton Rating Scale for Depression, 17-item Total Score (HAM-D17) | Baseline to Week 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline on the Clinical Global Impression Scale | Baseline to Week 10 | |
| Change From Baseline in Clinical Global Impression-Improvement (CGI-I) Scale | Baseline to Week 10 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huafang Li, Professor | Contact | 86-021-34773128 | lhlh_5@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Huafang Li, Professor | The Shanghai Mental Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong General Hospital | Recruiting | Guangzhou | Guangdong | China | ||
| The Second Xiangya Hospital of Central South University |
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| Drug |
|
| Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 10 |
| Baseline to Week 10 |
| Change From Baseline in Adjusted Mean on Montgomery-Asberg Depression Rating Scale (MADRS) | Baseline to Week 10 |
| Change From Baseline on the Visual Analogue Scale-Pain Intensity (VAS-PI) | Baseline to Week 10 |
| Number of Participants in Remission Based on the HAM-D17 at Week 10 | Remission was defined as a HAM-D17 score of less than or equal to 7. | Baseline to Week 10 |
| Recruiting |
| Changsha |
| Hunan |
| China |
| West China Hospital | Recruiting | Chengdu | Sichuan | China |
| Beijing An Ding Hospital | Recruiting | Beijing | 100088 | China |
| Beijing HuiLongGuan Hospital | Recruiting | Beijing | 100096 | China |
| The Shanghai Mental Health | Recruiting | Shanghai | 200030 | China |
|
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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