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.
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
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
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
Latvia4 sites
Study site
Jelgava, 3008
Study site
Liepāja, 3401
Study site
Riga, 1005
Study site
Strenči, 4730
South Africa4 sites
Study site
Bloemfontein, 9301
Study site
Cape Town, 9646
Study site
Durban, 4058
Study site
Pretoria, 157
Croatia3 sites
Study site
Rijeka, 51000
Study site
Split, 21000
Study site
Zagreb, 10090
Estonia3 sites
Study site
Tallinn, 126 18
Study site
Tartu, 50407
Study site
Tartu, 50417
Lithuania3 sites
Study site
Kaunas, 50185
Study site
Klaipėda, 91251
Study site
Vilnius, 10204
Poland3 sites
Study site
Lubiąż, 56-100
Study site
Tuszyn, 95 080
Study site
Żuromin, 09-300
Romania3 sites
Study site
Bucharest, 41914
Study site
Bucharest, 60011
Study site
Craiova, 200738
Slovakia3 sites
Study site
Bojnice, 97201
Study site
Bratislava, 82606
Study site
Rimavská Sobota, 97901
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.
- Conditions
- Depressive Disorder, Major
- 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.
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)
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.
- First posted8 Mar 2006 (estimated)
- Study startMar 2006
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Depressive Disorder, MajorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, Study director, Wyeth is now a wholly owned subsidiary of PfizerTrial Manager, Principal investigator, For France, infomedfrance@wyeth.comTrial Manager, Principal investigator, For Estonia, Latvia, Lithuania, WPVIMED@wyeth.comTrial Manager, Principal investigator, For Romania, WPVIMED@wyeth.comTrial Manager, Principal investigator, For Poland, WPWZMED@wyeth.comTrial Manager, Principal investigator, For Finland, MedInfoNord@wyeth.comTrial Manager, Principal investigator, For Croatia, WPBUMED@wyeth.comTrial Manager, Principal investigator, For South Africa, ZAFinfo@wyeth.com
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 34183490Soares 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 29140227McIntyre 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 26709542McIntyre 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 26644956Thase 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 25758058Soares 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