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Depressive Disorder, MajorPhase 3NCT00300378

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

A Phase 3 study testing desvenlafaxine 50 mg and desvenlafaxine 100 mg in people with Depressive Disorder, Major, run by Wyeth is now a wholly owned subsidiary of Pfizer at 43 sites in 10 countries.

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 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Depressive Disorder, Major
What is being tested?
desvenlafaxine 50 mg and desvenlafaxine 100 mg
How many people
480 participants
Where
43 sitesin 10 countries
Study dates
Mar 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

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

Who cannot join

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

Trial locations and contacts

43 sites in 10 countries.

43 sites in 10 countries

Finland10 sites

  • Study site

    Espoo, FIN-02650

  • Study site

    Helsinki, FIN-00100

  • Study site

    Helsinki, FIN-00260

  • Study site

    Helsinki, FIN-00530

  • Study site

    Joensuu, 80100

  • Study site

    Kuopio, 70110

  • Study site

    Oulu, 90 100

  • Study site

    Rauma, 26100

  • Study site

    Salo, 24100

  • Study site

    Turku, SF-20100

Other trials in Finland

France7 sites

  • Study site

    Caen, 14000

  • Study site

    Dole, 39100

  • Study site

    Douai, 59500

  • Study site

    Mulhouse, 68100

  • Study site

    Orvault, 44700

  • Study site

    Rennes, 35000

  • Study site

    Tours, 37300

Other trials in France

Latvia4 sites

  • Study site

    Jelgava, 3008

  • Study site

    Liepāja, 3401

  • Study site

    Riga, 1005

  • Study site

    Strenči, 4730

Other trials in Latvia

South Africa4 sites

  • Study site

    Bloemfontein, 9301

  • Study site

    Cape Town, 9646

  • Study site

    Durban, 4058

  • Study site

    Pretoria, 157

Other trials in South Africa

Croatia3 sites

  • Study site

    Rijeka, 51000

  • Study site

    Split, 21000

  • Study site

    Zagreb, 10090

Other trials in Croatia

Estonia3 sites

  • Study site

    Tallinn, 126 18

  • Study site

    Tartu, 50407

  • Study site

    Tartu, 50417

Other trials in Estonia

Lithuania3 sites

  • Study site

    Kaunas, 50185

  • Study site

    Klaipėda, 91251

  • Study site

    Vilnius, 10204

Other trials in Lithuania

Poland3 sites

  • Study site

    Lubiąż, 56-100

  • Study site

    Tuszyn, 95 080

  • Study site

    Żuromin, 09-300

Other trials in Poland

Romania3 sites

  • Study site

    Bucharest, 41914

  • Study site

    Bucharest, 60011

  • Study site

    Craiova, 200738

Other trials in Romania

Slovakia3 sites

  • Study site

    Bojnice, 97201

  • Study site

    Bratislava, 82606

  • Study site

    Rimavská Sobota, 97901

Other trials in Slovakia

About this study

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of 2 Fixed Doses (50 mg, 100 mg) of Desvenlafaxine Sustained-Release Tablets in Adult Outpatients With Major Depressive Disorder

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.

Being tested
desvenlafaxine 50 mg, desvenlafaxine 100 mg
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.

  • desvenlafaxine 50 mgDrug

  • desvenlafaxine 100 mgDrug

What is being measured

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

  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)

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

Timeline

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

  1. First posted8 Mar 2006 (estimated)
  2. Study startMar 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 (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00300378
Sponsor's protocol ID
3151A1-333
Status last verified
Dec 2007
First submitted
7 Mar 2006
Last updated
5 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing desvenlafaxine 50 mg and desvenlafaxine 100 mg in people with Depressive Disorder, Major, run by Wyeth is now a wholly owned subsidiary of Pfizer at 43 sites in 10 countries.

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 2 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 5 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 43 sites in Finland, France, Latvia, South Africa, Croatia and 5 more countries. 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 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. 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 NCT00300378, which also lists 6 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 5 Dec 2007.

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