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This is a multicenter, randomized withdrawal, double-blind, parallel, placebo-controlled design clinical trial of Toludesvenlafaxine Hydrochloride Extended-Release Tablets to evaluate the long-term efficacy and safety in the treatment of Chinese patients with depression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Toludesvenlafaxine Hydrochloride Sustained-release Tablets 80 mg or 160 mg group | Experimental | orally once a day |
|
| Placebo | Placebo Comparator | orally once a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Toludesvenlafaxine Hydrochloride Sustained-release Tablets | Drug | orally once a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to relapse. | from Baseline to week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Double-Blind Treatment Period Baseline in Montgomery - Eisberg Depression Rating Scale (MADRS) Total Score; | from Baseline to week 24 | |
| Change from Double-Blind Treatment Period Baseline in Clinical Global Impression Scale - Severity of Illness (CGI-S) score and Clinical Global Impression Scale - Global Improvement (CGI-I) score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hongyan Zhang | Contact | 13601237138 | hongyanzhang@bjmu.edu.cn |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| placebo | Drug | orally once a day |
|
| from Baseline to week 24 |
| Change From Double-Blind Treatment Period Baseline in Hamilton Anxiety Rating Scale (HAMA) Total Score. | from Baseline to week 24 |
| Change From Double-Blind Treatment Period Baseline in the Anhedonia Rating Scale (DARS) Score | from Baseline to week 24 |
| Change From Double-Blind Treatment Period Baseline in SHEEHAN Disability Scale (SDS) Score | from Baseline to week 24 |
| Change from Double-Blind Treatment Period Baseline in Digit Symbol Substitution Test (DSST) Score | from Baseline to week 24] |