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Major Depressive DisorderPhase 3NCT00277823

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

A Phase 3 study testing DVS-SR 50 mg and DVS-SR 100 mg in people with Major Depressive Disorder, run by Wyeth is now a wholly owned subsidiary of Pfizer at 25 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Major Depressive Disorder
What is being tested?
DVS-SR 50 mg and DVS-SR 100 mg
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
480 participants
Where
25 sitesUnited States
Study dates
Feb 2006to Jan 2007
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

25 sites in 1 country.

25 sites in 1 country

United States25 sites

  • Study site

    Beverly Hills, California, 90210

  • Study site

    Brown Deer, Wisconsin, 53223

  • Study site

    Charleston, South Carolina, 29407

  • Study site

    Clementon, New Jersey, 08021

  • Study site

    Columbia, South Carolina, 29201

  • Study site

    Dayton, Ohio, 45408

  • Study site

    Farmington, Connecticut, 06030

  • Study site

    Farmington Hills, Michigan, 48336

  • Study site

    Libertyville, Illinois, 60048

  • Study site

    Marietta, Georgia, 30060

  • Study site

    Miami, Florida, 33173

  • Study site

    Moorestown, New Jersey, 08057

  • Study site

    New Orleans, Louisiana, 70115

  • Study site

    New York, New York, 10021

  • Study site

    New York, New York, 10024

  • Study site

    Northridge, California, 91324

  • Study site

    Oklahoma City, Oklahoma, 73103

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Portland, Oregon, 97210

  • Study site

    Salt Lake City, Utah, 84107

  • Study site

    Seattle, Washington

  • Study site

    Smyrna, Georgia, 30080

  • Study site

    St. Petersburg, Florida, 33702

  • Study site

    Toledo, Ohio, 43623

  • Study site

    Washington D.C., District of Columbia, 20037

Other trials in United States

About this study

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Two Fixed Doses (50 mg, 100 mg) of Desvenlafaxine Sustained-Release Tablets in Adult Outpatients With Major Depressive Disorder

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.

Being tested
DVS-SR 50 mg, DVS-SR 100 mg, Placebo
Keywords
Depression, Adult, Outpatients
Medical subject headings
Depressive Disorder, Major, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DVS-SR 50 mgDrug

  • DVS-SR 100 mgDrug

  • PlaceboDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The primary objective 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.

Secondary outcomes (1)

  1. Additional objectives include testing both general and functional quality-of-life outcomes and satisfaction with therapy reported by the subject.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jan 2006 (estimated)
  2. Study startFeb 2006
  3. Study completionJan 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
480 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00277823
Sponsor's protocol ID
3151A1-332
Status last verified
Dec 2007
First submitted
12 Jan 2006
Last updated
28 Dec 2007
Results posted
No

Publications

  • 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.

    PubMed 34183490

  • 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.

    PubMed 29140227

  • 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.

    PubMed 26709542

  • 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.

    PubMed 26644956

  • 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.

    PubMed 25758058

  • 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.

    PubMed 24571916

  • 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.

    PubMed 18507895

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing DVS-SR 50 mg and DVS-SR 100 mg in people with Major Depressive Disorder, run by Wyeth is now a wholly owned subsidiary of Pfizer at 25 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary objective 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.. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00277823, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2007; AzTrials last refreshed its copy on 7 Nov 2026.

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