Study Evaluating Desvenlafaxine Sustained-Release (DVS-SR) in Adult Outpatients With Major Depressive Disorder

NCT ID: NCT00277823

Last Updated: 2007-12-28

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

2006-02-28

Study Completion Date

2007-01-31

Brief Summary

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The purpose of this study is to compare the antidepressant efficacy, safety, and tolerability of DVS-SR in subjects receiving daily doses of 50 mg or 100 mg of DVS-SR versus subjects receiving placebo.

Detailed Description

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Conditions

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Major Depressive Disorder

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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DVS-SR 50 mg

Intervention Type DRUG

DVS-SR 100 mg

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of major depressive disorder
* Must be able to swallow tablets
* Must be at least 18 years of age.

Exclusion Criteria

* Clinical diagnosis of other psychiatric disorders
* Significant risk of suicide
* Unstable medical conditions.
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

Locations

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Beverly Hills, California, United States

Site Status

Northridge, California, United States

Site Status

Farmington, Connecticut, United States

Site Status

Washington D.C., District of Columbia, United States

Site Status

Miami, Florida, United States

Site Status

St. Petersburg, Florida, United States

Site Status

Marietta, Georgia, United States

Site Status

Smyrna, Georgia, United States

Site Status

Libertyville, Illinois, United States

Site Status

New Orleans, Louisiana, United States

Site Status

Farmington Hills, Michigan, United States

Site Status

Clementon, New Jersey, United States

Site Status

Moorestown, New Jersey, United States

Site Status

New York, New York, United States

Site Status

New York, New York, United States

Site Status

Dayton, Ohio, United States

Site Status

Toledo, Ohio, United States

Site Status

Oklahoma City, Oklahoma, United States

Site Status

Portland, Oregon, United States

Site Status

Philadelphia, Pennsylvania, United States

Site Status

Charleston, South Carolina, United States

Site Status

Columbia, South Carolina, United States

Site Status

Salt Lake City, Utah, United States

Site Status

Seattle, Washington, United States

Site Status

Brown Deer, Wisconsin, United States

Site Status

Countries

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United States

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)

Liebowitz MR, Manley AL, Padmanabhan SK, Ganguly R, Tummala R, Tourian KA. Efficacy, safety, and tolerability of desvenlafaxine 50 mg/day and 100 mg/day in outpatients with major depressive disorder. Curr Med Res Opin. 2008 Jul;24(7):1877-90. doi: 10.1185/03007990802161923. Epub 2008 May 27.

Reference Type DERIVED
PMID: 18507895 (View on PubMed)

Other Identifiers

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3151A1-332

Identifier Type: -

Identifier Source: org_study_id