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To assess the comparative efficacy of sertraline versus venlafaxine XR on measures of quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sertaline group | Experimental |
| |
| Venlafaxine group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sertraline | Drug | Flexibly-titrated 50 mg tablets, 50-150 mg/day and venlafaxine placebo orally for 10 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in QOL, measured using the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q). | Weeks 1, 2, 3, 4, 6, 8, 9 and 10. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the 17-item Hamilton-Depression Rating Scale (HAM-D) including response (≥50% reduction in HAM-D total score from baseline) and remission (HAM-D total score ≤7) rates. | Weeks 1, 2, 3, 4, 6, 8, 9 and 10. | |
| The 17-item Hamilton-Depression Rating Scale response rates at endpoint (week 8). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Cairns | Queensland | 4870 | Australia | ||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| venlafaxine XR | Drug | Flexibly-titrated 75 mg capsules, 75-225mg/day and sertraline placebo orally for 10 weeks. |
|
| Week 8 |
| CGI response rate at endpoint (week 8). | Week 8 |
| Change from baseline in the CGI-Severity Scale (CGI-S). | Weeks 1, 2, 3, 4, 6, 8, 9 and 10. |
| Change from baseline in the Hamilton Anxiety Scale (HAM-A). | Weeks 1, 2, 3, 4, 6, 8, 9 and 10. |
| Change from baseline in the Endicott Work Productivity Scale (EWPS). | Weeks 1, 8, 9, 10 |
| Change from baseline in the Visual Analogue Scale (VAS) for Depression. | Weeks 1, 2, 3, 4, 6, 8, 9 and 10. |
| Change from baseline in the Visual Analogue Scale (VAS) for Overall Assessment of Pain. | Weeks 1, 2, 3, 4, 6, 8, 9 and 10. |
| Hamilton-Depression Rating Scale remission rates at endpoint (week 8). | Week 8 |
| Change from baseline in the Clinical Global Impression-Improvement Scale. | Weeks 1, 2, 3, 4, 6, 8 |
| Everton Park |
| Queensland |
| 4053 |
| Australia |
| Pfizer Investigational Site | North Cairns | Queensland | 4870 | Australia |
| Pfizer Investigational Site | Box Hill | Victoria | 3128 | Australia |
| Pfizer Investigational Site | Heidelberg | Victoria | 3084 | Australia |
| Pfizer Investigational Site | WEST Heidelberg | Victoria | 3081 | Australia |
| Pfizer Investigational Site | West Perth | Western Australia | 6005 | Australia |
| Pfizer Investigational Site | Adana | Turkey (Türkiye) |
| Pfizer Investigational Site | Ankara | Turkey (Türkiye) |
| Pfizer Investigational Site | Diyarbakır | Turkey (Türkiye) |
| Pfizer Investigational Site | Istanbul | Turkey (Türkiye) |
| Pfizer Investigational Site | Izmir | Turkey (Türkiye) |
| Pfizer Investigational Site | İzmit | Turkey (Türkiye) |
| Pfizer Investigational Site | Malatya | Turkey (Türkiye) |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D020280 | Sertraline |
| ID | Term |
|---|---|
| D015057 | 1-Naphthylamine |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
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