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The primary objective is to compare the antidepressant efficacy, safety, and tolerability of DVS SR versus placebo in subjects with Major Depressive Disorder. Additional objectives include testing both general and functional quality-of-life outcomes and satisfaction with therapy reported by the subject.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| desvenlafaxine 50 mg | Drug | |||
| desvenlafaxine 100 mg | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| The primary efficacy variable will be the change from baseline on the 17-item of the Hamilton Depression rating scale (HAM-D17 score) at the final on therapy evaluation |
| Measure | Description | Time Frame |
|---|---|---|
| The Global Clinical Improvement will be the key secondary efficacy variable. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Wyeth is now a wholly owned subsidiary of Pfizer | Study Director |
| Trial Manager | For France, infomedfrance@wyeth.com | Principal Investigator |
| Trial Manager | For Estonia, Latvia, Lithuania, WPVIMED@wyeth.com | Principal Investigator |
| Trial Manager | For Romania, WPVIMED@wyeth.com | Principal Investigator |
| Trial Manager | For Poland, WPWZMED@wyeth.com | Principal Investigator |
| Trial Manager | For Finland, MedInfoNord@wyeth.com | Principal Investigator |
| Trial Manager | For Croatia, WPBUMED@wyeth.com | Principal Investigator |
| Trial Manager | For South Africa, ZAFinfo@wyeth.com | Principal Investigator |
| Trial Manager | For Slovakia, DIS-WP-BV-EUBV01-Medical@wyeth.com | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rijeka | 51000 | Croatia | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34183490 | Derived | Zilcha-Mano S, Wang X, Wajsbrot DB, Boucher M, Fine SA, Rutherford BR. Trajectories of Function and Symptom Change in Desvenlafaxine Clinical Trials: Toward Personalized Treatment for Depression. J Clin Psychopharmacol. 2021 Sep-Oct 01;41(5):579-584. doi: 10.1097/JCP.0000000000001435. | |
| 29140227 | Derived | Soares CN, Zhang M, Boucher M. Categorical improvement in functional impairment in depressed patients treated with desvenlafaxine. CNS Spectr. 2019 Jun;24(3):322-332. doi: 10.1017/S1092852917000633. Epub 2017 Nov 15. |
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| Split |
| 21000 |
| Croatia |
| Zagreb | 10090 | Croatia |
| Tallinn | 126 18 | Estonia |
| Tartu | 50407 | Estonia |
| Tartu | 50417 | Estonia |
| Espoo | FIN-02650 | Finland |
| Helsinki | FIN-00100 | Finland |
| Helsinki | FIN-00260 | Finland |
| Helsinki | FIN-00530 | Finland |
| Joensuu | 80100 | Finland |
| Kuopio | 70110 | Finland |
| Oulu | 90 100 | Finland |
| Rauma | 26100 | Finland |
| Salo | 24100 | Finland |
| Turku | SF-20100 | Finland |
| Caen | 14000 | France |
| Dole | 39100 | France |
| Douai | 59500 | France |
| Mulhouse | 68100 | France |
| Orvault | 44700 | France |
| Rennes | 35000 | France |
| Tours | 37300 | France |
| Jelgava | 3008 | Latvia |
| Liepāja | 3401 | Latvia |
| Riga | 1005 | Latvia |
| Strenči | 4730 | Latvia |
| Kaunas | 50185 | Lithuania |
| Klaipėda | 91251 | Lithuania |
| Vilnius | 10204 | Lithuania |
| Lubiąż | 56-100 | Poland |
| Tuszyn | 95 080 | Poland |
| Żuromin | 09-300 | Poland |
| Bucharest | 41914 | Romania |
| Bucharest | 60011 | Romania |
| Craiova | 200738 | Romania |
| Bojnice | 97201 | Slovakia |
| Bratislava | 82606 | Slovakia |
| Rimavská Sobota | 97901 | Slovakia |
| Bloemfontein | 9301 | South Africa |
| Cape Town | 9646 | South Africa |
| Durban | 4058 | South Africa |
| Pretoria | 157 | South Africa |
| 26709542 | Derived | McIntyre RS, Fayyad R, Mackell JA, Boucher M. Effect of metabolic syndrome and thyroid hormone on efficacy of desvenlafaxine 50 and 100 mg/d in major depressive disorder. Curr Med Res Opin. 2016;32(3):587-99. doi: 10.1185/03007995.2015.1136603. Epub 2016 Jan 13. |
| 26644956 | Derived | McIntyre RS, Fayyad RS, Guico-Pabia CJ, Boucher M. A Post Hoc Analysis of the Effect of Weight on Efficacy in Depressed Patients Treated With Desvenlafaxine 50 mg/d and 100 mg/d. Prim Care Companion CNS Disord. 2015 Jun 4;17(3):10.4088/PCC.14m01741. doi: 10.4088/PCC.14m01741. eCollection 2015. |
| 25758058 | Derived | Thase ME, Fayyad R, Cheng RF, Guico-Pabia CJ, Sporn J, Boucher M, Tourian KA. Effects of desvenlafaxine on blood pressure in patients treated for major depressive disorder: a pooled analysis. Curr Med Res Opin. 2015 Apr;31(4):809-20. doi: 10.1185/03007995.2015.1020365. Epub 2015 Mar 26. |
| 24571916 | Derived | Soares CN, Endicott J, Boucher M, Fayyad RS, Guico-Pabia CJ. Predictors of functional response and remission with desvenlafaxine 50 mg/d in patients with major depressive disorder. CNS Spectr. 2014 Dec;19(6):519-27. doi: 10.1017/S1092852914000066. Epub 2014 Feb 26. |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000069468 | Desvenlafaxine Succinate |
| ID | Term |
|---|---|
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D008055 | Lipids |
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