Major Depressive DisorderPhase 3NCT00798707

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

A Phase 3 study testing Desvenlafaxine Succinate Sustained-Release (DVS SR) in people with Major Depressive Disorder, run by Pfizer at 78 sites in 2 countries.

Completed

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

Official record

Search all trials

Trial summary

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. 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?: Desvenlafaxine Succinate Sustained-Release (DVS SR)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 709 participants
Where: 78 sitesin 2 countries
Study dates: Dec 2008to Apr 2010
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

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

Who cannot join

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

Trial locations and contacts

78 sites in 2 countries.

Country

City, postcode or hospital

78 sites in 2 countries

Japan59 sites

Pfizer Investigational Site
Bunkyo, Tokyo, 1120012
Pfizer Investigational Site
Chiyoda City, Tokyo, 1000006
Pfizer Investigational Site
Chiyoda City, Tokyo, 1018643
Pfizer Investigational Site
Fujioka, Gunma, 3750017
Pfizer Investigational Site
Fukuoka, Fukuoka, 8100001
Pfizer Investigational Site
Fukuoka, Fukuoka, 8100041
Pfizer Investigational Site
Fukushima, Fukushima, 9600102
Pfizer Investigational Site
Hatsukaichi, Hiroshima, 7380023
Pfizer Investigational Site
Hiroshima, Hiroshima, 7310121
Pfizer Investigational Site
Kanazawa, Ishikawa-ken, 9208650
Pfizer Investigational Site
Kanzaka, Saga-ken, 8420192
Pfizer Investigational Site
Katsushika-ku, Tokyo, 1250041
Pfizer Investigational Site
Kitakyushu, Fukuoka, 8020006
Pfizer Investigational Site
Kitakyushu, Fukuoka, 8078555
Pfizer Investigational Site
Kobe, Hyōgo, 6530841
Pfizer Investigational Site
Kodaira, Tokyo, 1858551
Pfizer Investigational Site
Kumagaya, Gunma, 3600032
Pfizer Investigational Site
Kumamoto, Kumamoto, 8618002
Pfizer Investigational Site
Kumamoto, Kumamoto, 8620909
Pfizer Investigational Site
Kure, Hiroshima, 7370023
Pfizer Investigational Site
Kusatsu, Shiga, 5250037
Pfizer Investigational Site
Kyoto, Kyoto, 6168421
Pfizer Investigational Site
Matsumoto, Nagano, 3908510
Pfizer Investigational Site
Meguro City, Toyko, 1520012
Pfizer Investigational Site
Minamiashigara, Kanagawa, 2500136
Pfizer Investigational Site
Minato, Tokyo, 1070052
Pfizer Investigational Site
Misato, Saitama, Saitama, 3410018
Pfizer Investigational Site
Nagoya, Aichi-ken, 4530015
Pfizer Investigational Site
Nakano City, Tokyo, 1640012
Pfizer Investigational Site
Noda, Chiba, 2780033
Pfizer Investigational Site
Osaka, Osaka, 5420006
Pfizer Investigational Site
Saitama, Saitama, 33000062
Pfizer Investigational Site
Saitama, Saitama, 3390057
Pfizer Investigational Site
Sakai, Osaka, 5900018
Pfizer Investigational Site
Sapporo, Hokkaido, 0028029
Pfizer Investigational Site
Sapporo, Hokkaido, 0040052
Pfizer Investigational Site
Sapporo, Hokkaido, 0600061
Pfizer Investigational Site
Sapporo, Hokkaido, 600042
Pfizer Investigational Site
Sapporo, Hokkaido, 630061
Pfizer Investigational Site
Sapporo, Hokkaido, 630804
Pfizer Investigational Site
Setagaya City, Tokyo, 1540012
Pfizer Investigational Site
Setagaya-ku, Tokyo, 1540004
Pfizer Investigational Site
Shibuya City, Tokyo, 1500001
Pfizer Investigational Site
Shibuya City, Tokyo, 1510053
Pfizer Investigational Site
Shinagawa, Tokyo, 1410021
Pfizer Investigational Site
Shinagawa, Tokyo, 1410022
Pfizer Investigational Site
Shinagawa, Tokyo, 1420021
Pfizer Investigational Site
Shinjyuku, Tokyo, 1600023
Pfizer Investigational Site
Shirakawa, Fukushima, 9610021
Pfizer Investigational Site
Suginami, Tokyo, 1660003
Pfizer Investigational Site
tabashi City, Tokyo, 1730004
Pfizer Investigational Site
Taitō City, Tokyo, 1100003
Pfizer Investigational Site
Toshima City, Tokyo, 1700002
Pfizer Investigational Site
Toyoake, Aichi-ken, 4701192
Pfizer Investigational Site
Ube, Yamaguchi, 7558505
Pfizer Investigational Site
Yatsushiro, Kumamoto, 8660043
Pfizer Investigational Site
Yokohama, Kanagawa, 2200004
Pfizer Investigational Site
Yokohama, Kanagawa, 2210835
Pfizer Investigational Site
Yokohama, Kanagawa, 2250012

Other trials in Japan

United States19 sites

Pfizer Investigational Site
Arcadia, California, 91007
Pfizer Investigational Site
Atlanta, Georgia, 30328
Pfizer Investigational Site
Beverly Hills, California, 90210
Pfizer Investigational Site
Brown Deer, Wisconsin, 53223
Pfizer Investigational Site
Cerritos, California, 90703
Pfizer Investigational Site
Columbia, South Carolina, 29201
Pfizer Investigational Site
Dallas, Texas, 75230
Pfizer Investigational Site
Dayton, Ohio, 45408
Pfizer Investigational Site
East Providence, Rhode Island, 02914
Pfizer Investigational Site
Garden Grove, California, 92845
Pfizer Investigational Site
Kirkland, Washington, 98033
Pfizer Investigational Site
Libertyville, Illinois, 60048
Pfizer Investigational Site
Los Alamitos, California, 90720
Pfizer Investigational Site
Memphis, Tennessee, 38117
Pfizer Investigational Site
Salt Lake City, Utah, 84107
Pfizer Investigational Site
San Antonio, Texas, 78229
Pfizer Investigational Site
Seattle, Washington, 98104
Pfizer Investigational Site
Smyrna, Georgia, 30080
Pfizer Investigational Site
St. Petersburg, Florida, 33702

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 2 Fixed Doses (25 and 50 mg/Day) of DVS SR Tablets in Adult Outpatients With Major Depressive Disorder

Conditions: Major Depressive Disorder
Being tested: Desvenlafaxine Succinate Sustained-Release (DVS SR), placebo
Keywords: Major Depressive Disorder
Medical subject headings: Depressive Disorder, Major

What participants receive

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

Desvenlafaxine Succinate Sustained-Release (DVS SR)Drug
25 mg tablet, once daily dosing for 8 weeks
Desvenlafaxine Succinate Sustained-Release (DVS SR)Drug
50 mg tablet, once daily dosing for 8 weeks
placeboDrug
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.

Study groups in NCT00798707
Study group	Role	What they receive
Desvenlafaxine succinate sustained-release 25 mg	Experimental	Not described Receives: Drug: Desvenlafaxine Succinate Sustained-Release (DVS SR)
Desvenlafaxine succinate sustained-release 50 mg	Experimental	Not described Receives: Drug: Desvenlafaxine Succinate Sustained-Release (DVS SR)
Placebo	Placebo comparator	Not described Receives: Drug: placebo

What is being measured

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

Change From Baseline in HAM-D17 Total Score at the Final On-therapy (FOT)Evaluation (Week 8 or ET)
HAM-D17: a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0=none/absent and 4=most severe, for a maximum total score of 50.
Measured: Baseline and Week 8 (or ET)

Secondary outcomes (8)

Number of Participants With Categorical Scores on CGI-Improvement (CGI-I) at FOT Evaluation (Week 8 or ET)
CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.
Measured: Week 8 (or ET)
Change From Baseline in Mean CGI-S Score at FOT Evaluation (Week 8 or ET)
CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected.
Measured: Baseline and Week 8 (or ET)
Change From Baseline in MADRS Total Score at FOT Evaluation (Week 8 or ET)
MADRS measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).
Measured: Baseline and Week 8 (or ET)
Change From Baseline in HAM-D6 Total Score at FOT Evaluation (Week 8 or ET)
HAM-D6: a standardized, clinician-administered rating scale that assesses 6 items characteristically associated with major depression and is a subset of HAM-D17. HAM-D6 score ranges from 0-22. The scale uses HAM-D17 items: 1, 2, 7, 8, 10 and 13. Item 13 is scored 0-2 and all others are scored 0-4.
Measured: Baseline and Week 8 (or ET)
Number of Participants With a Response on the HAM-D17 at FOT Evaluation (Week 8 or ET)
A HAM-D17 responder was defined as a participant with a 50% or greater decrease from baseline in HAM-D17 score. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0=none/absent and 4=most severe, for a maximum total score of 50.
Measured: Week 8 (or ET)
Number of Participants in Remission Based on the HAM-D17 at FOT Evaluation (Week 8 or ET)
Remission was defined as a HAM-D17 score of less than or equal to 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0=none/absent and 4=most severe, for a maximum total score of 50.
Measured: Week 8 (or ET)
Number of Participants With a Response on the MADRS Score at FOT Evaluation (Week 8 or ET)
A MADRS responder was defined as a participant with a 50% or greater decrease from baseline in MADRS score. It measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).
Measured: Week 8 (or ET)
Number of Participants With a Response on the CGI-I Score at FOT Evaluation (Week 8 or ET)
CGI-I responder was defined as a participant with a score of 1 (very much improved) or 2 (much improved) on the CGI-I. CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.
Measured: Week 8 (or ET)

Timeline

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

Dec 2008Apr 2010

First posted26 Nov 2008 (estimated)
Study startDec 2008
Primary completionApr 2010
Study completionApr 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 709 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00798707
Sponsor's protocol ID: 3151A1-3359
Other IDs: B2061003, 3151A1-3359-WW
Status last verified: Jun 2011
First submitted: 25 Nov 2008
Last updated: 10 Jun 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: 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
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.
PubMed 23334675

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 10 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of 2 Fixed Doses (25 and 50 mg/Day) of DVS SR Tablets in Adult Outpatients With Major Depressive Disorder
ClinicalTrials.gov ID: NCT00798707
Acronym / sponsor ID: 3151A1-3359
Conditions: Major Depressive Disorder
Keywords: Major Depressive Disorder
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 709 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Dec 2008
Primary completion: Apr 2010 (actual)
Study completion: Apr 2010 (actual)
First posted: 26 Nov 2008 (estimated)
Results: Posted 6 Jun 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Desvenlafaxine succinate sustained-release 25 mg	Experimental	Drug: Desvenlafaxine Succinate Sustained-Release (DVS SR)
Desvenlafaxine succinate sustained-release 50 mg	Experimental	Drug: Desvenlafaxine Succinate Sustained-Release (DVS SR)
Placebo	Placebo comparator	Drug: placebo

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Desvenlafaxine Succinate Sustained-Release (DVS SR)25 mg tablet, once daily dosing for 8 weeks	Drug	Desvenlafaxine succinate sustained-release 25 mg
Desvenlafaxine Succinate Sustained-Release (DVS SR)50 mg tablet, once daily dosing for 8 weeks	Drug	Desvenlafaxine succinate sustained-release 50 mg
placeboMatching 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.	Drug	Placebo

Primary outcome

Change From Baseline in HAM-D17 Total Score at the Final On-therapy (FOT)Evaluation (Week 8 or ET)
Time frame: Baseline and Week 8 (or ET)
HAM-D17: a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0=none/absent and 4=most severe, for a maximum total score of 50.

8 secondary outcomes

Number of Participants With Categorical Scores on CGI-Improvement (CGI-I) at FOT Evaluation (Week 8 or ET)
Time frame: Week 8 (or ET)
Change From Baseline in Mean CGI-S Score at FOT Evaluation (Week 8 or ET)
Time frame: Baseline and Week 8 (or ET)
Change From Baseline in MADRS Total Score at FOT Evaluation (Week 8 or ET)
Time frame: Baseline and Week 8 (or ET)
Change From Baseline in HAM-D6 Total Score at FOT Evaluation (Week 8 or ET)
Time frame: Baseline and Week 8 (or ET)
Number of Participants With a Response on the HAM-D17 at FOT Evaluation (Week 8 or ET)
Time frame: Week 8 (or ET)
Number of Participants in Remission Based on the HAM-D17 at FOT Evaluation (Week 8 or ET)
Time frame: Week 8 (or ET)
Number of Participants With a Response on the MADRS Score at FOT Evaluation (Week 8 or ET)
Time frame: Week 8 (or ET)
Number of Participants With a Response on the CGI-I Score at FOT Evaluation (Week 8 or ET)
Time frame: Week 8 (or ET)

Results and safety

Results posted to the registry on 6 Jun 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	235	209
DVS SR 25 mg	237	204
DVS SR 50 mg	237	215

Primary outcome: Change From Baseline in HAM-D17 Total Score at the Final On-therapy (FOT)Evaluation (Week 8 or ET)

Time frame: Baseline and Week 8 (or ET). Mean (Standard Error). Unit: Units on a scale

Measure	Placebo n = 231	DVS SR 25 mg n = 232	DVS SR 50 mg n = 236
Value	-8.52 (0.44)	-8.98 (0.44)	-10.02 (0.44)

Placebo vs DVS SR 25 mg: Mean Difference (Final Values): 0.47 (95% CI -0.75 to 1.69), p = 0.452, ANCOVA
Placebo vs DVS SR 50 mg: Mean Difference (Final Values): 1.50 (95% CI 0.28 to 2.72), p = 0.016, ANCOVA

Population analysed: Intent-To-Treat (ITT) Population:all randomly assigned participants with baseline primary efficacy evaluation, had taken at least 1 dose of double-blind drug and 1 primary efficacy evaluation after first dose of double-blind drug. If participant had missing value at any visit, last observation carried forward (LOCF) method of imputation was used.

8 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	3 of 231 (1.3%)	158 of 231 (68.4%)	Not reported
DVS SR 25 mg	1 of 232 (0.4%)	160 of 232 (69%)	Not reported
DVS SR 50 mg	5 of 236 (2.1%)	174 of 236 (73.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34183490Zilcha-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.
Derived from this study: PubMed 29140227Soares 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.
Derived from this study: PubMed 26709542McIntyre 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.
Derived from this study: PubMed 26644956McIntyre 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.
Derived from this study: PubMed 25758058Thase 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.
Derived from this study: PubMed 23334675Iwata 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.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

78 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Desvenlafaxine Succinate Sustained-Release (DVS SR) in people with Major Depressive Disorder, run by Pfizer at 78 sites in 2 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 3 inclusion and 2 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 10 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 78 sites in Japan, 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 6 Jun 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change From Baseline in HAM-D17 Total Score at the Final On-therapy (FOT)Evaluation (Week 8 or ET) (time frame: Baseline and Week 8 (or ET)). 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 NCT00798707, 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 10 Jun 2011.