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

NCT ID: NCT00300378

Last Updated: 2007-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

480 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2007-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Depressive Disorder, Major

Keywords

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Depression Adult Outpatients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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desvenlafaxine 50 mg

Intervention Type DRUG

desvenlafaxine 100 mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role lead

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For France, [email protected]

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For Estonia, Latvia, Lithuania, [email protected]

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For Romania, [email protected]

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For Poland, [email protected]

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For Finland, [email protected]

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For Croatia, [email protected]

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For South Africa, [email protected]

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For Slovakia, [email protected]

Locations

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Rijeka, , Croatia

Site Status

Split, , Croatia

Site Status

Zagreb, , Croatia

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Tallinn, , Estonia

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Tartu, , Estonia

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Tartu, , Estonia

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Espoo, , Finland

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Helsinki, , Finland

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Helsinki, , Finland

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Helsinki, , Finland

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Joensuu, , Finland

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Kuopio, , Finland

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Oulu, , Finland

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Rauma, , Finland

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Salo, , Finland

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Turku, , Finland

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Caen, , France

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Dole, , France

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Douai, , France

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Mulhouse, , France

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Orvault, , France

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Rennes, , France

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Tours, , France

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Jelgava, , Latvia

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Liepāja, , Latvia

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Riga, , Latvia

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Strenči, , Latvia

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Kaunas, , Lithuania

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Klaipėda, , Lithuania

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Vilnius, , Lithuania

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Lubiąż, , Poland

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Tuszyn, , Poland

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Żuromin, , Poland

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Bucharest, , Romania

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Bucharest, , Romania

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Craiova, , Romania

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Bojnice, , Slovakia

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Bratislava, , Slovakia

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Rimavská Sobota, , Slovakia

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Bloemfontein, , South Africa

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Cape Town, , South Africa

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Durban, , South Africa

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Pretoria, , South Africa

Site Status

Countries

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Croatia Estonia Finland France Latvia Lithuania Poland Romania Slovakia South Africa

References

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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.

Reference Type DERIVED
PMID: 34183490 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29140227 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26709542 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26644956 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25758058 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24571916 (View on PubMed)

Other Identifiers

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3151A1-333

Identifier Type: -

Identifier Source: org_study_id