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This study was designed to determine if the novel combination of the SSRI, sertraline, and the NRI reboxetine will increase antidepressant efficacy without sacrificing the favorable safety profile of SSRIs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sertraline/[S,S]-Reboxetine-satellite150/4 | Experimental |
| |
| Sertraline/[S,S]-Reboxetine-satellite150/6 | Experimental |
| |
| sertraline-satellite | Active Comparator |
| |
| sertraline-main | Active Comparator |
| |
| Sertraline/[S,S]-Reboxetine-satellite150/2 | Experimental |
| |
| Placebo | Placebo Comparator |
| |
| Sertraline/[S,S]-Reboxetine-main | Experimental |
| |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sertraline/[S,S]-reboxetine | Drug | Tablets, 50mg sertraline/2mg [S,S]-reboxetine for 3 days orally, followed by 100mg sertraline/4mg [S,S]-reboxetine for 4 and one half weeks, followed by 150mg sertraline/4mg [S,S]-reboxetine for 5 and one half weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| The change from Baseline up to Week 8 (Visit 9) in the Montgomery-Asberg Depression Rating Scale (MADRS) total score as measured by a mixed concentration, suicidal ideation and restlessness. | visits 1-9 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in HAM-D (17-item) total score | Weeks 1, 2, 3, 5, 6, and 8 | |
| Change from Baseline in the Hamilton Anxiety Rating Scale (HAM-A) and Apathy Evaluation Scale (AES) | Weeks 5 and 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 | Viljandi | Viljandi Mk. | 71024 | Estonia | ||
| 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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| [S,S]-reboxetine-main |
| Active Comparator |
|
| sertraline/[S,S]-reboxetine | Drug | Tablets, 50mg sertraline/2mg [S,S]-reboxetine for 3 days orally, followed by 100mg sertraline/4mg [S,S]-reboxetine for 4 and one half weeks, followed by 150mg sertraline/6mg [S,S]-reboxetine for 5 and one half weeks. |
|
| sertraline | Drug | Tablets, 50 mg/day orally for 3 days, followed by 100 mg/day orally for 4 and one half weeks, followed by 150 mg/day orally for 3 weeks. |
|
| sertraline | Drug | Tablets, 50 mg/day orally for 3 days, followed by 100 mg/day orally for 4 and one half weeks, followed by 150 mg/day orally for 3 weeks |
|
| sertraline/[S,S]-reboxetine | Drug | Tablets, 50mg sertraline/2mg [S,S]-reboxetine for 3 days orally, followed by 100mg sertraline/2mg [S,S]-reboxetine for 4 and one half weeks, followed by 150mg sertraline/2mg [S,S]-reboxetine for 5 and one half weeks. |
|
| Placebo | Drug | Tablets, orally once per day for 8 weeks |
|
| sertraline/[S,S]-reboxetine | Drug | Tablets, 50mg sertraline/2mg [S,S]-reboxetine orally for 3 days, followed by 100mg sertraline/2mg [S,S]-reboxetine for 4 and one half weeks, followed by 150mg sertraline/2mg [S,S]-reboxetine for 5 and one half weeks |
|
| [S,S]-reboxetine monotherapy | Drug | Tablets, 2 mg/day orally for 3 days, followed by 4 mg/day orally for 4 and one half weeks, followed by 6mg/day for 3 weeks |
|
| The frequency and severity of treatment-emergent adverse events, ECG changes, laboratory and vital signs changes by treatment group using descriptive statistics. | Weeks 1, 2, 3, 5, 6, and 8 |
| Change from Baseline in MADRS total score | Weeks 1, 2, 3, 5, 6, and 8 |
| Pärnu |
| 80012 |
| Estonia |
| Pfizer Investigational Site | Tallinn | 10614 | Estonia |
| Pfizer Investigational Site | Tartu | 51008 | Estonia |
| Pfizer Investigational Site | Kazan' | 420012 | Russia |
| Pfizer Investigational Site | Moscow | 107076 | Russia |
| Pfizer Investigational Site | Moscow | 115522 | Russia |
| Pfizer Investigational Site | Moscow | 119034 | Russia |
| Pfizer Investigational Site | Moscow | 127473 | Russia |
| Pfizer Investigational Site | Moscow | Russia |
| Pfizer Investigational Site | Rostov-on-Don | 344010 | Russia |
| Pfizer Investigational Site | Saint Petersburg | 190121 | Russia |
| Pfizer Investigational Site | Saint Petersburg | 192019 | Russia |
| Pfizer Investigational Site | Saint Petersburg | 193167 | Russia |
| Pfizer Investigational Site | Saint Petersburg | 194214 | Russia |
| Pfizer Investigational Site | Smolensk | 214019 | Russia |
| Pfizer Investigational Site | Tomsk | 634014 | Russia |
| 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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