Study Evaluating the Efficacy and Safety of Desvenlafaxine Tablets in Adult Outpatients With Major Depressive Disorder

NCT00300378 | Completed Phase 3

• 1 other identifier: 3151A1-333
• Study Type: interventional
• Target: 480
• Locations: 10 countries
• Sites: 43

Brief Summary

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.

Conditions

Depressive Disorder, Major

Keywords

Depression; Adult; Outpatients

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• The Global Clinical Improvement will be the key secondary efficacy variable.

Interventions

desvenlafaxine 50 mg DRUG

desvenlafaxine 100 mg DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A primary diagnosis of MDD
• Depressive symptoms for at least 30 days before the screening visit.

You may not qualify if:

• Treatment with DVS SR at any time in the past.
• Known hypersensitivity to venlafaxine
• Significant risk of suicide based on clinical judgment

Sponsors & Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer: lead

Study Sites (43)

Unknown Facility

Rijeka, 51000, Croatia

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Split, 21000, Croatia

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Zagreb, 10090, Croatia

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Tallinn, 126 18, Estonia

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Tartu, 50407, Estonia

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Tartu, 50417, Estonia

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Espoo, FIN-02650, Finland

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Helsinki, FIN-00100, Finland

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Helsinki, FIN-00260, Finland

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Helsinki, FIN-00530, Finland

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Joensuu, 80100, Finland

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Kuopio, 70110, Finland

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Oulu, 90 100, Finland

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Rauma, 26100, Finland

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Salo, 24100, Finland

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Turku, SF-20100, Finland

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Caen, 14000, France

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Dole, 39100, France

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Douai, 59500, France

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Mulhouse, 68100, France

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Orvault, 44700, France

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Rennes, 35000, France

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Tours, 37300, France

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Jelgava, 3008, Latvia

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Liepāja, 3401, Latvia

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Riga, 1005, Latvia

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Strenči, 4730, Latvia

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Kaunas, 50185, Lithuania

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Klaipėda, 91251, Lithuania

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Vilnius, 10204, Lithuania

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Lubiąż, 56-100, Poland

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Tuszyn, 95 080, Poland

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Żuromin, 09-300, Poland

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Bucharest, 41914, Romania

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Bucharest, 60011, Romania

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Craiova, 200738, Romania

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Bojnice, 97201, Slovakia

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Bratislava, 82606, Slovakia

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Rimavská Sobota, 97901, Slovakia

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Bloemfontein, 9301, South Africa

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Cape Town, 9646, South Africa

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Durban, 4058, South Africa

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Pretoria, 157, South Africa

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Related Publications (6)

• 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.

  PMID: 34183490 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.

  PMID: 29140227 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.

  PMID: 26709542 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.

  PMID: 26644956 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.

  PMID: 25758058 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.

  PMID: 24571916 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Interventions

Desvenlafaxine Succinate

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Lipids

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 7, 2006
• First Posted: March 8, 2006
• Study Start: March 1, 2006
• Study Completion: January 1, 2007
• Last Updated: December 5, 2007

Record last verified: 2007-12

Locations

ES (3); LI (3); FR (7); RO (3); PL (3); LA (4); FI (10); ZA (4); CR (3); SL (3)