Major Depressive DisorderPhase 3NCT00863798

Study Evaluating Desvenlafaxine Succinate Sustained Release In Adults With Major Depressive Disorder

A Phase 3 study testing Desvenlafaxine Succinate Sustained-Release 10mg and Desvenlafaxine Succinate Sustained-Release 50 mg in people with Major Depressive Disorder, run by Wyeth is now a wholly owned subsidiary of Pfizer at 24 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 compare the antidepressant efficacy and safety of two doses of desvenlafaxine succinate sustained release (10 and 50 mg/day) in 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 10mg and Desvenlafaxine Succinate Sustained-Release 50 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 682 participants
Where: 24 sitesUnited States
Study dates: Apr 2009to Mar 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 judgment, HAM-D 17 and Columbia Suicide-Severity Rating Scale scores Other eligibility criteria also apply.

Trial locations and contacts

24 sites in 1 country.

City, postcode or hospital

24 sites in 1 country

United States24 sites

Pfizer Investigational Site
Aurora, Colorado, 80045
Pfizer Investigational Site
Birmingham, Alabama, 35216
Pfizer Investigational Site
Cromwell, Connecticut, 06416
Pfizer Investigational Site
Denver, Colorado, 80204
Pfizer Investigational Site
Encino, California, 91316
Pfizer Investigational Site
Eugene, Oregon, 97401
Pfizer Investigational Site
Herndon, Virginia, 20170
Pfizer Investigational Site
Indianapolis, Indiana, 46260
Pfizer Investigational Site
Maitland, Florida, 32751
Pfizer Investigational Site
Media, Pennsylvania, 19063
Pfizer Investigational Site
Middleton, Wisconsin, 53562
Pfizer Investigational Site
Midlothian, Virginia, 23112
Pfizer Investigational Site
New York, New York, 10128
Pfizer Investigational Site
Newport Beach, California, 92660
Pfizer Investigational Site
North Miami, Florida, 33161
Pfizer Investigational Site
Portland, Oregon, 97210
Pfizer Investigational Site
Redlands, California, 92374
Pfizer Investigational Site
Salem, Oregon, 97301
Pfizer Investigational Site
South Miami, Florida, 33143
Pfizer Investigational Site
St Louis, Missouri, 63139
Pfizer Investigational Site
Staten Island, New York, 10312
Pfizer Investigational Site
Toledo, Ohio, 43623
Pfizer Investigational Site
Upland, California, 91786
Pfizer Investigational Site
Waukesha, Wisconsin, 53188

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 (10 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 10mg, Desvenlafaxine Succinate Sustained-Release 50 mg, 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 10mgDrug
10 mg tablet, once daily dosing for 8 weeks
Desvenlafaxine Succinate Sustained-Release 50 mgDrug
50 mg tablet, once daily dosing for 8 weeks
placeboDrug
Matching placebo tablets (10 or 50mg). Daily dosing for 10 +/- 4 days during a placebo lead-in period, and then 8 weeks during the double-blind period.

Study groups in NCT00863798
Study group	Role	What they receive
Desvenlafaxine succinate sustained release 10 mg	Experimental	Not described Receives: Drug: Desvenlafaxine Succinate Sustained-Release 10mg
Desvenlafaxine succinate sustained release 50 mg	Experimental	Not described Receives: Drug: Desvenlafaxine Succinate Sustained-Release 50 mg
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 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. 0=none/absent and 22=most severe.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.

Apr 2009Mar 2010

First posted18 Mar 2009 (estimated)
Study startApr 2009
Primary completionMar 2010
Study completionMar 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 (7)Papers the sponsor has linked to this study.
Other trials for Major Depressive DisorderStudies 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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 682 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00863798
Sponsor's protocol ID: 3151A1-3362
Other IDs: B2061005, 3151A1-3362-US
Status last verified: Apr 2011
First submitted: 17 Mar 2009
Last updated: 6 May 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
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, Tourian KA, Hwang E, Mele L; Study 3362 Investigators. A double-blind, randomized, placebo-controlled study assessing the efficacy and tolerability of desvenlafaxine 10 and 50 mg/day in adult outpatients with major depressive disorder. BMC Psychiatry. 2013 Mar 22;13:94. doi: 10.1186/1471-244X-13-94.
PubMed 23517291

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

Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Not yet recruiting
Acute Intermittent Hypoxia Therapy for Depression
Major Depressive Disorder (MDD)

All Major Depressive Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 6 May 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 (10 And 50 mg/Day) Of DVS SR Tablets In Adult Outpatients With Major Depressive Disorder
ClinicalTrials.gov ID: NCT00863798
Acronym / sponsor ID: 3151A1-3362
Conditions: Major Depressive Disorder
Keywords: Major Depressive Disorder
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 682 participants (actual)
Lead sponsor: Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
Collaborators: Pfizer
Study start: Apr 2009
Primary completion: Mar 2010 (actual)
Study completion: Mar 2010 (actual)
First posted: 18 Mar 2009 (estimated)
Results: Posted 6 May 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 10 mg	Experimental	Drug: Desvenlafaxine Succinate Sustained-Release 10mg
Desvenlafaxine succinate sustained release 50 mg	Experimental	Drug: Desvenlafaxine Succinate Sustained-Release 50 mg
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 judgment, 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 10mg10 mg tablet, once daily dosing for 8 weeks	Drug	Desvenlafaxine succinate sustained release 10 mg
Desvenlafaxine Succinate Sustained-Release 50 mg50 mg tablet, once daily dosing for 8 weeks	Drug	Desvenlafaxine succinate sustained release 50 mg
placeboMatching placebo tablets (10 or 50mg). 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 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 May 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	227	195
DVS SR 10 mg	228	198
DVS SR 50 mg	227	202

Primary outcome: Change From Baseline in HAM-D17 Total Score at 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 = 223	DVS SR 10 mg n = 226	DVS SR 50 mg n = 224
Value	-8.42 (0.45)	-9.28 (0.45)	-8.92 (0.45)

Placebo vs DVS SR 10 mg: Mean Difference (Final Values): 0.86 (95% CI -0.38 to 2.10), p = 0.175, ANCOVA
Placebo vs DVS SR 50 mg: Mean Difference (Final Values): 0.51 (95% CI -0.73 to 1.75), p = 0.421, 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 223 (1.3%)	166 of 223 (74.4%)	Not reported
DVS SR 10 mg	1 of 226 (0.4%)	168 of 226 (74.3%)	Not reported
DVS SR 50 mg	1 of 224 (0.4%)	170 of 224 (75.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 May 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 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 23517291Liebowitz MR, Tourian KA, Hwang E, Mele L; Study 3362 Investigators. A double-blind, randomized, placebo-controlled study assessing the efficacy and tolerability of desvenlafaxine 10 and 50 mg/day in adult outpatients with major depressive disorder. BMC Psychiatry. 2013 Mar 22;13:94. doi: 10.1186/1471-244X-13-94.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Related trials for Major Depressive Disorder

Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Not yet recruiting
Acute Intermittent Hypoxia Therapy for Depression
Major Depressive Disorder (MDD)

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

24 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 6 May 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 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 6 May 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 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 NCT00863798, 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 6 May 2011.