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Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) in the Treatment of Major Depressive Disorder

NCT ID: NCT00798707

Last Updated: 2011-06-10

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

709 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2010-04-30

Brief Summary

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The primary purpose of this study is to compare the antidepressant efficacy and safety of two doses of DVS SR (25 and 50 mg/day) in the treatment of adults with Major Depressive Disorder. The study will also assess changes in sexual function and general and functional quality of life outcomes.

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Detailed Description

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Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Desvenlafaxine succinate sustained-release 25 mg

Group Type EXPERIMENTAL

Desvenlafaxine Succinate Sustained-Release (DVS SR)

Intervention Type DRUG

25 mg tablet, once daily dosing for 8 weeks

Desvenlafaxine succinate sustained-release 50 mg

Group Type EXPERIMENTAL

Desvenlafaxine Succinate Sustained-Release (DVS SR)

Intervention Type DRUG

50 mg tablet, once daily dosing for 8 weeks

Placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Matching placebo tablets (25 or 50 mg). Daily dosing for 10 +/- 4 days during a placebo lead-in period, and then 8 weeks during the double-blind period.

Interventions

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Desvenlafaxine Succinate Sustained-Release (DVS SR)

25 mg tablet, once daily dosing for 8 weeks

Intervention Type DRUG

Desvenlafaxine Succinate Sustained-Release (DVS SR)

50 mg tablet, once daily dosing for 8 weeks

Intervention Type DRUG

placebo

Matching placebo tablets (25 or 50 mg). Daily dosing for 10 +/- 4 days during a placebo lead-in period, and then 8 weeks during the double-blind period.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adult, outpatient with primary diagnosis of Major Depressive Disorder (depressive symptoms for at least 30 days prior to screening)
* Hamilton Psychiatric Rating Scale for Depression (HAM-D 17) total score of \>= 20
* Clinical Global Impressions Scale-Severity (CGI-S) score of \>= 4

Exclusion Criteria

* Clinical instability - 25% or greater increase/decrease in HAM-D 17 total score from screening to baseline
* Significant risk of suicide as assessed by clinician judgement, HAM-D 17 and Columbia Suicide-Severity Rating Scale scores Other eligibility criteria also apply
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Arcadia, California, United States

Site Status

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Beverly Hills, California, United States

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Cerritos, California, United States

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Garden Grove, California, United States

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Los Alamitos, California, United States

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St. Petersburg, Florida, United States

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Atlanta, Georgia, United States

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Smyrna, Georgia, United States

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Libertyville, Illinois, United States

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Dayton, Ohio, United States

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East Providence, Rhode Island, United States

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Columbia, South Carolina, United States

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Memphis, Tennessee, United States

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Dallas, Texas, United States

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San Antonio, Texas, United States

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Salt Lake City, Utah, United States

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Kirkland, Washington, United States

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Seattle, Washington, United States

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Brown Deer, Wisconsin, United States

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Nagoya, Aichi-ken, Japan

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Toyoake, Aichi-ken, Japan

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Noda, Chiba, Japan

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Fukuoka, Fukuoka, Japan

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Fukuoka, Fukuoka, Japan

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Kitakyushu, Fukuoka, Japan

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Kitakyushu, Fukuoka, Japan

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Fukushima, Fukushima, Japan

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Shirakawa, Fukushima, Japan

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Fujioka, Gunma, Japan

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Kumagaya, Gunma, Japan

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Hatsukaichi, Hiroshima, Japan

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Hiroshima, Hiroshima, Japan

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Kure, Hiroshima, Japan

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Sapporo, Hokkaido, Japan

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Sapporo, Hokkaido, Japan

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Sapporo, Hokkaido, Japan

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Sapporo, Hokkaido, Japan

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Sapporo, Hokkaido, Japan

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Sapporo, Hokkaido, Japan

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Kobe, Hyōgo, Japan

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Kanazawa, Ishikawa-ken, Japan

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Minamiashigara, Kanagawa, Japan

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Yokohama, Kanagawa, Japan

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Yokohama, Kanagawa, Japan

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Yokohama, Kanagawa, Japan

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Kumamoto, Kumamoto, Japan

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Kumamoto, Kumamoto, Japan

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Yatsushiro, Kumamoto, Japan

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Kyoto, Kyoto, Japan

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Matsumoto, Nagano, Japan

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Osaka, Osaka, Japan

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Sakai, Osaka, Japan

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Kanzaka, Saga-ken, Japan

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Misato, Saitama, Saitama, Japan

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Saitama, Saitama, Japan

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Saitama, Saitama, Japan

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Kusatsu, Shiga, Japan

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Bunkyo, Tokyo, Japan

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Chiyoda City, Tokyo, Japan

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Chiyoda City, Tokyo, Japan

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Katsushika-ku, Tokyo, Japan

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Kodaira, Tokyo, Japan

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Minato, Tokyo, Japan

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Nakano City, Tokyo, Japan

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Setagaya City, Tokyo, Japan

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Setagaya-ku, Tokyo, Japan

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Shibuya City, Tokyo, Japan

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Shibuya City, Tokyo, Japan

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Shinagawa, Tokyo, Japan

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Shinagawa, Tokyo, Japan

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Shinagawa, Tokyo, Japan

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Shinjyuku, Tokyo, Japan

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Suginami, Tokyo, Japan

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tabashi City, Tokyo, Japan

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Taitō City, Tokyo, Japan

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Toshima City, Tokyo, Japan

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Meguro City, Toyko, Japan

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Ube, Yamaguchi, Japan

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Countries

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United States Japan

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)

Iwata N, Tourian KA, Hwang E, Mele L, Vialet C. Efficacy and safety of desvenlafaxine 25 and 5050% shaded blockmg/day in a randomized, placebo-controlled study of depressed outpatients. J Psychiatr Pract. 2013 Jan;19(1):5-14. doi: 10.1097/01.pra.0000426323.59698.64.

Reference Type DERIVED
PMID: 23334675 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=3151A1-3359&StudyName=Study%20Evaluating%20Desvenlafaxine%20Succinate%20Sustained%20Release%20%28DVS%20SR%29%20in%20the%20Treatment%20of%20Major%20Depressive%20Disorder

To obtain contact information for a study center near you, click here.

Other Identifiers

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B2061003

Identifier Type: -

Identifier Source: secondary_id

3151A1-3359-WW

Identifier Type: -

Identifier Source: secondary_id

3151A1-3359

Identifier Type: -

Identifier Source: org_study_id

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