Depressive Disorder, MajorPhase 3NCT00824291
Study Evaluating Desvenlafaxine Succinate Sustained Release In Outpatients With Major Depressive Disorder
A Phase 3 study testing desvenlafaxine succinate sustained release and Genotyping in people with Depressive Disorder, Major, run by Wyeth is now a wholly owned subsidiary of Pfizer.
Trial summary
This is a multicenter study to assess the health and well-being in subjects who are outpatients with major depressive disorder that take desvenlafaxine succinate sustained release (DVS SR) or placebo for 12 weeks. Read more about this study
- Who is it for?
- Ages 19 to 74 years
- Conditions the study is for
- Depressive Disorder, Major
- What is being tested?
- desvenlafaxine succinate sustained release and Genotyping
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 437 participants
- Where
- No sites listed yet
- Study dates
- Feb 2009to Nov 2009
- 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 19 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Outpatient men and women, between the ages of 18 to 75 years, fluent in both written and spoken English.
- Employed for 20 hours or more for a minimum of 1 month prior to baseline.
- Primary diagnosis of Major Depressive Disorder with symptoms for at least 30 days prior to baseline.
Who cannot join
- Treatment with desvenlafaxine succinate sustained release at any time in the past and/or venlafaxine (Effexor or Effexor XR) 1 year prior to baseline.
- Treatment-resistant defined as any of the following failed treatments in the past 3 years: 3 or more previous adequate trials of >=2 classes of antidepressant medication, electroconvulsive therapy, or psychotherapy (2 adequate trials).
- Current (within 12 months prior to the screening visit) psychoactive substance abuse or dependence (including alcohol), manic episode, posttraumatic stress disorder, obsessive-compulsive disorder, or a lifetime diagnosis of bipolar or psychotic disorder.
- Clinically important abnormalities on physical examination, electrocardiogram (ECG), or laboratory evaluations.
About this study
Official title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study To Evaluate Functional Outcome In Outpatients With Major Depressive Disorder Treated With Desvenlafaxine Succinare Sustained Release
This is a multicenter study to assess the health and well-being in subjects who are outpatients with major depressive disorder that take desvenlafaxine succinate sustained release (DVS SR) or placebo for 12 weeks.
- Conditions
- Depressive Disorder, Major
- Being tested
- desvenlafaxine succinate sustained release, Genotyping
- 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 releaseDrug
Also called Pristiq
50 mg/day oral tablet for 12 weeks
GenotypingGenetic
CYP2D6 genotyping at randomization
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Not described Receives: Drug: desvenlafaxine succinate sustained release |
| 2 | Experimental | Not described Receives: Genetic: Genotyping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Hamilton Depression Scale (HAM-D) at Week 12
HAM-D, clinician-rated interview, measures presence of depressive symptoms in 17 areas (symptoms such as depressed mood, guilt feelings, suicide, sleep disturbances, anxiety levels and weight loss). Total score ranges from 0 to 52; higher scores indicate more depression. Change from baseline: mean at observation minus mean at baseline.
Measured: At Baseline and Week 12.
Secondary outcomes (7)
Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 12
Participant rated scale was used to assess the effect of the participant's symptoms on their work/social/family life. Total scores range from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life. Individual item scores range from 0 to 10.
Measured: At Baseline and Week 12.
Clinical Global Impression Scale - Improvement (CGI- I) Score at Week 12
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. Change = score at observation minus score at baseline.
Measured: At Baseline and Week 12.
Clinical Global Impressions Scale - Severity of Illness (CGI-S) at Week 12
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. Change: score at observation minus score at baseline.
Measured: At Baseline and Week 12.
Change From Baseline on Work and Activities Item of HAM-D17 at Week 12
The Work and Activities Item of the HAM-D17 is item 7 of HAM-D17. Scoring range from 0 to 4.
Measured: At Baseline and Week 12.
Change From Baseline in Adjusted Mean on Montgomery-Asberg Depression Rating Scale (MADRS) at Week 12
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: At Baseline and Week 12.
Change From Baseline on Worry Anxiety Tension Scale (WATS) at Week 12
WATS: a self-administered, 3-question rating scale assesses worry, anxiety, and tension. Each item was a visual analog scale on which the participant circles a number from 0 to 10. Higher scores indicated worse function. WATS total score was the sum of the 3 items. If 1 item was missing, the total score would be missing.
Measured: At Baseline and Week 12.
Change From Baseline on Stress and Social Support Scales at Week 12
Stress and Social Support Scales: self-administered rating scale where item 1 is the stress vulnerability scale measuring how much the subject was set back by stressful events on an 11-point scale ranging from 0 (not at all) to 10 (extremely) and item 2 is an 11-point scale ranging from 0 to 100 percent of the amount of support the subject received from relatives and friends.
Measured: At Baseline and Week 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2009 (estimated)
- Study startFeb 2009
- Primary completionOct 2009
- Study completionNov 2009
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 (9)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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 437 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00824291
- Sponsor's protocol ID
- 3151A1-4415
- Other IDs
- B2061006
- Status last verified
- Mar 2011
- First submitted
- 14 Jan 2009
- Last updated
- 10 Mar 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 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 29140227Reddy S, Fayyad R, Edgar CJ, Guico-Pabia CJ, Wesnes K. The effect of desvenlafaxine on cognitive functioning in employed outpatients with major depressive disorder: a substudy of a randomized, double-blind, placebo-controlled trial. J Psychopharmacol. 2016 Jun;30(6):559-67. doi: 10.1177/0269881116631649. Epub 2016 Mar 23.
PubMed 27009044McIntyre 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 25758058Endicott J, Lam RW, Hsu MA, Fayyad R, Boucher M, Guico-Pabia CJ. Improvements in quality of life with desvenlafaxine 50mg/d vs placebo in employed adults with major depressive disorder. J Affect Disord. 2014 Sep;166:307-14. doi: 10.1016/j.jad.2014.05.011. Epub 2014 May 21.
PubMed 25012446Lam RW, Endicott J, Hsu MA, Fayyad R, Guico-Pabia C, Boucher M. Predictors of functional improvement in employed adults with major depressive disorder treated with desvenlafaxine. Int Clin Psychopharmacol. 2014 Sep;29(5):239-51. doi: 10.1097/YIC.0000000000000031.
PubMed 24583567Soares 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
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study To Evaluate Functional Outcome In Outpatients With Major Depressive Disorder Treated With Desvenlafaxine Succinare Sustained Release
- ClinicalTrials.gov ID
- NCT00824291
- Acronym / sponsor ID
- 3151A1-4415
- Conditions
- Depressive Disorder, Major
- Keywords
- Major Depressive Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 437 participants (actual)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 16 Jan 2009 (estimated)
- Results
- Posted 25 Nov 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter study to assess the health and well-being in subjects who are outpatients with major depressive disorder that take desvenlafaxine succinate sustained release (DVS SR) or placebo for 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: desvenlafaxine succinate sustained release |
| 2 | Experimental | Genetic: Genotyping |
Who may qualify
- Ages
- 19 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Outpatient men and women, between the ages of 18 to 75 years, fluent in both written and spoken English.
- Employed for 20 hours or more for a minimum of 1 month prior to baseline.
- Primary diagnosis of Major Depressive Disorder with symptoms for at least 30 days prior to baseline.
Key exclusion criteria (4 listed)
- Treatment with desvenlafaxine succinate sustained release at any time in the past and/or venlafaxine (Effexor or Effexor XR) 1 year prior to baseline.
- Treatment-resistant defined as any of the following failed treatments in the past 3 years: 3 or more previous adequate trials of >=2 classes of antidepressant medication, electroconvulsive therapy, or psychotherapy (2 adequate trials).
- Current (within 12 months prior to the screening visit) psychoactive substance abuse or dependence (including alcohol), manic episode, posttraumatic stress disorder, obsessive-compulsive disorder, or a lifetime diagnosis of bipolar or psychotic disorder.
- Clinically important abnormalities on physical examination, electrocardiogram (ECG), or laboratory evaluations.
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 releaseAlso: Pristiq50 mg/day oral tablet for 12 weeks | Drug | 1 |
| GenotypingCYP2D6 genotyping at randomization | Genetic | 2 |
Primary outcome
Change From Baseline in Hamilton Depression Scale (HAM-D) at Week 12
Time frame: At Baseline and Week 12.
HAM-D, clinician-rated interview, measures presence of depressive symptoms in 17 areas (symptoms such as depressed mood, guilt feelings, suicide, sleep disturbances, anxiety levels and weight loss). Total score ranges from 0 to 52; higher scores indicate more depression. Change from baseline: mean at observation minus mean at baseline.
7 secondary outcomes
Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 12
Time frame: At Baseline and Week 12.
Clinical Global Impression Scale - Improvement (CGI- I) Score at Week 12
Time frame: At Baseline and Week 12.
Clinical Global Impressions Scale - Severity of Illness (CGI-S) at Week 12
Time frame: At Baseline and Week 12.
Change From Baseline on Work and Activities Item of HAM-D17 at Week 12
Time frame: At Baseline and Week 12.
Change From Baseline in Adjusted Mean on Montgomery-Asberg Depression Rating Scale (MADRS) at Week 12
Time frame: At Baseline and Week 12.
Change From Baseline on Worry Anxiety Tension Scale (WATS) at Week 12
Time frame: At Baseline and Week 12.
Change From Baseline on Stress and Social Support Scales at Week 12
Time frame: At Baseline and Week 12.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 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 27009044Reddy S, Fayyad R, Edgar CJ, Guico-Pabia CJ, Wesnes K. The effect of desvenlafaxine on cognitive functioning in employed outpatients with major depressive disorder: a substudy of a randomized, double-blind, placebo-controlled trial. J Psychopharmacol. 2016 Jun;30(6):559-67. doi: 10.1177/0269881116631649. Epub 2016 Mar 23.
- 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 25012446Endicott J, Lam RW, Hsu MA, Fayyad R, Boucher M, Guico-Pabia CJ. Improvements in quality of life with desvenlafaxine 50mg/d vs placebo in employed adults with major depressive disorder. J Affect Disord. 2014 Sep;166:307-14. doi: 10.1016/j.jad.2014.05.011. Epub 2014 May 21.
- Derived from this study: PubMed 24583567Lam RW, Endicott J, Hsu MA, Fayyad R, Guico-Pabia C, Boucher M. Predictors of functional improvement in employed adults with major depressive disorder treated with desvenlafaxine. Int Clin Psychopharmacol. 2014 Sep;29(5):239-51. doi: 10.1097/YIC.0000000000000031.
- 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.
- 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
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing desvenlafaxine succinate sustained release and Genotyping in people with Depressive Disorder, Major, run by Wyeth is now a wholly owned subsidiary of Pfizer.
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 4 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 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
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 25 Nov 2010). 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 Hamilton Depression Scale (HAM-D) at Week 12 (time frame: At Baseline and Week 12.). 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 NCT00824291, which also lists 9 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 Mar 2011.