Depressive Disorder, MajorPhase 3NCT00384033

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) and Duloxetine 60 mg/day in people with Depressive Disorder, Major, run by Pfizer at 22 sites in United States.

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 evaluate the efficacy and safety of two doses of DVS SR (50 and 100 mg/day) in the treatment of adults with Major Depressive Disorder. 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 Succinate Sustained-Release (DVS SR) and Duloxetine 60 mg/day
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 638 participants
Where: 22 sitesUnited States
Study dates: Sep 2006to Sep 2007
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
Adult, Older adult

Who may be able to join

A primary diagnosis of Major Depressive Disorder, single or recurrent episode, without psychotic features.
Depressive symptoms for at least 30 days before the screening visit.
Outpatient men and women at least 18 years of age.

Who cannot join

Significant risk of suicide based on clinical judgment, including common suicidal thoughts and suicide having been considered as a possible solution even without specific plans or intent.
Any unstable hepatic, renal, pulmonary, cardiovascular (including uncontrolled hypertension), ophthalmologic, neurologic, or any other medical condition that might confound the study or put the subject at greater risk during study participation.
Current (within 12 months before baseline) psychoactive substance abuse or dependence (including alcohol), manic episode, posttraumatic stress disorder, obsessive-compulsive disorder, or a lifetime diagnosis of bipolar or psychotic disorder; b) current (within 12 months before baseline) generalized anxiety disorder, panic disorder, or social anxiety disorder; c) presence (within 12 months before baseline) of a clinically important personality disorder as assessed during the psychiatric assessments.

Trial locations and contacts

22 sites in 1 country.

City, postcode or hospital

22 sites in 1 country

United States22 sites

Pfizer Investigational Site
Beverly Hills, California, 90210
Pfizer Investigational Site
Brown Deer, Wisconsin, 53223
Pfizer Investigational Site
Burbank, California, 91506
Pfizer Investigational Site
Clementon, New Jersey, 08021
Pfizer Investigational Site
Dayton, Ohio, 45408
Pfizer Investigational Site
Edwardsville, Illinois, 62025
Pfizer Investigational Site
Encino, California, 91316
Pfizer Investigational Site
Farmington Hills, Michigan, 48336
Pfizer Investigational Site
Flint, Michigan, 48507
Pfizer Investigational Site
Los Alamitos, California, 90720
Pfizer Investigational Site
Newport Beach, California, 92660
Pfizer Investigational Site
Northridge, California, 91324
Pfizer Investigational Site
Okemos, Michigan, 48864
Pfizer Investigational Site
Orange, California, 92868
Pfizer Investigational Site
Pasadena, California, 91105
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19149
Pfizer Investigational Site
Portland, Oregon, 97210
Pfizer Investigational Site
Salt Lake City, Utah, 84107
Pfizer Investigational Site
Seattle, Washington, 98104
Pfizer Investigational Site
South Miami, Florida, 33143
Pfizer Investigational Site
St. Petersburg, Florida, 33702
Pfizer Investigational Site
Upland, California, 91786

Other trials in United States

About this study

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

The primary purpose of this study is to evaluate the efficacy and safety of two doses of DVS SR (50 and 100 mg/day) in the treatment of adults with Major Depressive Disorder.

Conditions: Depressive Disorder, Major
Being tested: Desvenlafaxine Succinate Sustained-Release (DVS SR), Placebo, Duloxetine 60 mg/day
Keywords: MDD, Major Depressive Disorder, Depression
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 Succinate Sustained-Release (DVS SR)Drug
50 mg tablet, once daily dosing for 8 weeks
Desvenlafaxine Succinate Sustained-Release (DVS SR)Drug
100 mg tablet, once daily dosing for 8 weeks
PlaceboDrug
Matching placebo tablets and capsules, once daily dosing for 8 weeks
Duloxetine 60 mg/dayDrug
60 mg capsule, once daily dosing for 8 weeks

Study groups in NCT00384033
Study group	Role	What they receive
Desvenlafaxine succinate sustained-release 50 mg	Experimental	Not described Receives: Drug: Desvenlafaxine Succinate Sustained-Release (DVS SR)
Desvenlafaxine succinate sustained-release 100 mg	Experimental	Not described Receives: Drug: Desvenlafaxine Succinate Sustained-Release (DVS SR)
Placebo	Placebo comparator	Not described Receives: Drug: Placebo
Duloxetine 60mg	Other	Active control to assess assay sensitivity Receives: Drug: Duloxetine 60 mg/day

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 Week 8 or Final On-therapy (FOT) Evaluation
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 FOT

Secondary outcomes (8)

Number of Participants With Categorical Scores on CGI-Improvement (CGI-I) Score at Week 8 or FOT Evaluation
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 relative to the baseline assessment. Higher score = more affected.
Measured: Week 8 or FOT
Change From Baseline in Mean CGI-S Score at Week 8 or FOT Evaluation
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 participants). Higher score = more affected.
Measured: Baseline and Week 8 or FOT
Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score at Week 8 or FOT Evaluation
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 FOT
Change From Baseline in the Lassitude Item of the MADRS Scale at Week 8 or FOT Evaluation
Lassitude item of MADRS represents a difficulty in getting started or slowness in initiating and performing everyday activities. It is rated on a scale of 0-6: 0 = hardly any difficulty in getting started/no sluggishness; 2 = difficulties in starting activities; 4 = difficulties in starting simple routine activities which are carried out with effort; 6 = complete lassitude/unable to do anything without help.
Measured: Baseline and Week 8 or FOT
Change From Baseline in HAM-D6 Total Score at Week 8 or FOT Evaluation
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 (0=none and 2=severe) and all others are scored 0-4 (0=none/absent and 4=most severe).
Measured: Baseline and Week 8 or FOT
Change From Baseline in the HAM-D Energy Subscale Score at Week 8 or FOT Evaluation
HAM-D energy subscale is a subset of the HAM-D17 that assesses 4 items associated with major depression. The scale uses HAM- D17 items 1, 7, 8 and 14. Item 14 is scored 0 to 2 (0=none/absent to 2=most severe) and all others are scored 0 to 4 (0=none/absent to 4=most severe).
Measured: Baseline and Week 8 or FOT
Change From Baseline in Covi Anxiety Scale at Week 8 or FOT Evaluation
COVI anxiety scale measures the severity of anxiety symptoms on 3 items: verbal report, behavior and somatic complaints. Each dimension is assessed using a 5-point scale: 1 = not at all, 2 = somewhat, 3 = moderately, 4 = considerably, to 5 = Very much. Worst value is 15 and best value is 3.
Measured: Baseline and Week 8 or FOT
Change From Baseline in Visual Analog Scale-Pain Intensity (VAS-PI) Overall and Subcomponent Score at Week 8 or FOT Evaluation
VAS-PI scale assesses intensity of back pain, chest pain, arms, legs or joint pain as well as overall pain intensity where 100 mm line (VAS) is marked by participant and intensity of pain ranges from 0 millimetre (mm) = no pain to 100 mm = worst possible pain. There were separate 0 to 100 mm VAS lines for each subcomponent of VAS-PI.
Measured: Baseline and Week 8 or FOT

Timeline

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

Sep 2006Sep 2007

First posted4 Oct 2006 (estimated)
Study startSep 2006
Primary completionSep 2007
Study completionSep 2007

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 (7)Papers the sponsor has linked to this study.
Other trials for Depressive Disorder, MajorStudies 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: 638 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00384033
Sponsor's protocol ID: 3151A1-335
Status last verified: Feb 2012
First submitted: 2 Oct 2006
Last updated: 15 Mar 2012
Results posted: Yes, on ClinicalTrials.gov

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
Tourian KA, Padmanabhan SK, Groark J, Brisard C, Farrington D. Desvenlafaxine 50 and 100 mg/d in the treatment of major depressive disorder: an 8-week, phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial and a post hoc pooled analysis of three studies. Clin Ther. 2009 Jun;31 Pt 1:1405-23. doi: 10.1016/j.clinthera.2009.07.006.
PubMed 19698901

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?

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Study at a glance

From the registry record, last updated by the sponsor on 15 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Duloxetine-Referenced, Parallel-Group Study to Evaluate the Efficacy and Safety of 2 Fixed Doses (50mg, 100mg) of Desvenlafaxine Sustained-Release Tablets in Adult Outpatients With Major Depressive Disorder
ClinicalTrials.gov ID: NCT00384033
Acronym / sponsor ID: 3151A1-335
Conditions: Depressive Disorder, Major
Keywords: MDD, Major Depressive Disorder, Depression
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 638 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Sep 2006
Primary completion: Sep 2007 (actual)
Study completion: Sep 2007 (actual)
First posted: 4 Oct 2006 (estimated)
Results: Posted 15 Mar 2012

Clinical summary

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

The primary purpose of this study is to evaluate the efficacy and safety of two doses of DVS SR (50 and 100 mg/day) in the treatment of adults with Major Depressive Disorder.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Desvenlafaxine succinate sustained-release 50 mg	Experimental	Drug: Desvenlafaxine Succinate Sustained-Release (DVS SR)
Desvenlafaxine succinate sustained-release 100 mg	Experimental	Drug: Desvenlafaxine Succinate Sustained-Release (DVS SR)
Placebo	Placebo comparator	Drug: Placebo
Duloxetine 60mg	Other	Drug: Duloxetine 60 mg/dayActive control to assess assay sensitivity

Who may qualify

Ages: 18 years and older
Sex: All
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

A primary diagnosis of Major Depressive Disorder, single or recurrent episode, without psychotic features.
Depressive symptoms for at least 30 days before the screening visit.
Outpatient men and women at least 18 years of age.

Key exclusion criteria (3 listed)

Significant risk of suicide based on clinical judgment, including common suicidal thoughts and suicide having been considered as a possible solution even without specific plans or intent.
Any unstable hepatic, renal, pulmonary, cardiovascular (including uncontrolled hypertension), ophthalmologic, neurologic, or any other medical condition that might confound the study or put the subject at greater risk during study participation.
Current (within 12 months before baseline) psychoactive substance abuse or dependence (including alcohol), manic episode, posttraumatic stress disorder, obsessive-compulsive disorder, or a lifetime diagnosis of bipolar or psychotic disorder; b) current (within 12 months before baseline) generalized anxiety disorder, panic disorder, or social anxiety disorder; c) presence (within 12 months before baseline) of a clinically important personality disorder as assessed during the psychiatric assessments.

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)50 mg tablet, once daily dosing for 8 weeks	Drug	Desvenlafaxine succinate sustained-release 50 mg
Desvenlafaxine Succinate Sustained-Release (DVS SR)100 mg tablet, once daily dosing for 8 weeks	Drug	Desvenlafaxine succinate sustained-release 100 mg
PlaceboMatching placebo tablets and capsules, once daily dosing for 8 weeks	Drug	Placebo
Duloxetine 60 mg/day60 mg capsule, once daily dosing for 8 weeks	Drug	Duloxetine 60mg

Primary outcome

Change From Baseline in HAM-D17 Total Score at Week 8 or Final On-therapy (FOT) Evaluation
Time frame: Baseline and Week 8 or FOT
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) Score at Week 8 or FOT Evaluation
Time frame: Week 8 or FOT
Change From Baseline in Mean CGI-S Score at Week 8 or FOT Evaluation
Time frame: Baseline and Week 8 or FOT
Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score at Week 8 or FOT Evaluation
Time frame: Baseline and Week 8 or FOT
Change From Baseline in the Lassitude Item of the MADRS Scale at Week 8 or FOT Evaluation
Time frame: Baseline and Week 8 or FOT
Change From Baseline in HAM-D6 Total Score at Week 8 or FOT Evaluation
Time frame: Baseline and Week 8 or FOT
Change From Baseline in the HAM-D Energy Subscale Score at Week 8 or FOT Evaluation
Time frame: Baseline and Week 8 or FOT
Change From Baseline in Covi Anxiety Scale at Week 8 or FOT Evaluation
Time frame: Baseline and Week 8 or FOT
Change From Baseline in Visual Analog Scale-Pain Intensity (VAS-PI) Overall and Subcomponent Score at Week 8 or FOT Evaluation
Time frame: Baseline and Week 8 or FOT

Results and safety

Results posted to the registry on 15 Mar 2012, 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	164	123
DVS SR 50 mg	155	120
DVS SR 100 mg	160	117
Duloxetine 60 mg	159	119

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

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

Measure	Placebo n = 160	DVS SR 50 mg n = 148	DVS SR 100 mg n = 150	Duloxetine 60 mg n = 157
Value	-8.68 (0.58)	-9.75 (0.60)	-10.5 (0.60)	-10.3 (0.60)

Placebo vs DVS SR 50 mg: Mean Difference (Final Values): 1.10 (95% CI -0.60 to 2.70), p = 0.198, ANCOVA
Placebo vs DVS SR 100 mg: Mean Difference (Final Values): 1.80 (95% CI 0.20 to 3.40), p = 0.028, ANCOVA
Placebo vs Duloxetine 60 mg: Mean Difference (Final Values): 1.70 (95% CI 0.00 to 3.40), p = 0.047, ANCOVA

Population analysed: Intent-to-treat (ITT) population included all randomized participants who had a baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study medication, and had at least 1 primary efficacy evaluation after the first dose of double-blind study medication.

8 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	2 of 161 (1.2%)	129 of 161 (80.1%)	Not reported
DVS SR 50 mg	2 of 148 (1.4%)	134 of 148 (90.5%)	Not reported
DVS SR 100 mg	2 of 150 (1.3%)	134 of 150 (89.3%)	Not reported
Duloxetine 60 mg	1 of 157 (0.6%)	141 of 157 (89.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2012.
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 24571916Soares 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.
Derived from this study: PubMed 19698901Tourian KA, Padmanabhan SK, Groark J, Brisard C, Farrington D. Desvenlafaxine 50 and 100 mg/d in the treatment of major depressive disorder: an 8-week, phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial and a post hoc pooled analysis of three studies. Clin Ther. 2009 Jun;31 Pt 1:1405-23. doi: 10.1016/j.clinthera.2009.07.006.
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

22 sites in 1 country: 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) and Duloxetine 60 mg/day in people with Depressive Disorder, Major, run by Pfizer at 22 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 15 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 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. 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 15 Mar 2012). 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 Week 8 or Final On-therapy (FOT) Evaluation (time frame: Baseline and Week 8 or FOT). 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 NCT00384033, 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 15 Mar 2012.