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See Detailed Description for termination reason.
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A six week, fixed dose, double-blind, double-dummy, placebo, and active controlled, multicentre trial to evaluate the safety and efficacy of CP-316,311 in outpatients with major depressive disorder.
This study was terminated on March 17th, 2006. The results of the primary analysis at the interim showed that the CP-316,311 group was not significantly different than the placebo on the primary endpoint and therefore the data monitoring committee recommended termination of the trial. The decision to terminate the trial was not based on any safety concerns.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CP-316,311 | Drug | |||
| Placebo | Drug | |||
| Sertraline | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in HAM-D (17) at the week 6 visit |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in MADRS, HAM-A, CGI-S and CGI-I at the week 6 visit. |
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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 | Bellevue | Washington | United States | |||
| Pfizer Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18413705 | Derived | Binneman B, Feltner D, Kolluri S, Shi Y, Qiu R, Stiger T. A 6-week randomized, placebo-controlled trial of CP-316,311 (a selective CRH1 antagonist) in the treatment of major depression. Am J Psychiatry. 2008 May;165(5):617-20. doi: 10.1176/appi.ajp.2008.07071199. Epub 2008 Apr 15. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| Seattle |
| Washington |
| United States |
| Pfizer Investigational Site | Moscow | Russia |
| Pfizer Investigational Site | Rostov-on-Don | Russia |
| Pfizer Investigational Site | Saint Petersburg | Russia |
| Pfizer Investigational Site | Smolensk | Russia |
| Pfizer Investigational Site | Belgrade | Serbia | Serbia and Montenegro |
| Pfizer Investigational Site | Kragujevac | Serbia | Serbia and Montenegro |
| Pfizer Investigational Site | Novi Sad | Serbia | Serbia and Montenegro |
| Pfizer Investigational Site | Belgrade | Serbia and Montenegro |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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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