DepressionPhase 3NCT00369343
Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) Versus Placebo in Peri- and Postmenopausal Women
A Phase 3 study testing Desvenlafaxine administered as a succinate salt in a sustained-release form (DVS SR) in people with Depression and Depressive Disorder, run by Wyeth is now a wholly owned subsidiary of Pfizer at 37 sites in United States.
Trial summary
Desvenlafaxine succinate (DVS) is a potent and selective serotonin and norepinephrine reuptake inhibitor (SNRI). The sustained-release (SR) formulation, DVS SR, is being studied in the development program for the treatment of major depressive disorder (MDD), for vasomotor symptoms (VMS) associated with menopause, and… Read more about this study
- Who is it for?
- Ages 40 to 70 years, women only
- Conditions the study is for
- Depression, Depressive Disorder, Depressive Disorder, Major
- What is being tested?
- Desvenlafaxine administered as a succinate salt in a sustained-release form (DVS SR)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 381 participants
- Where
- 37 sitesUnited States
- Study dates
- Sep 2006to Jul 2008
- 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 40 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Peri- and postmenopausal women between the ages of 40 and 70 years, inclusive.
- A primary diagnosis of MDD, single or recurrent episode, without psychotic features using the modified International Neuropsychiatric Interview (MINI).
- Montgomery-Asberg Depression Rating Scale (MADRS) total score > or = 22 at the screening and baseline visit.
Who cannot join
- Use of oral estrogen-, progestin-, androgen-, or Selective Estrogen Receptor Modulator (SERM)-containing drug products 8 weeks before baseline.
- Current (within 12 months) psychoactive substance abuse or dependence (including alcohol), manic episode, post-traumatic stress disorder, obsessive-compulsive disorder, or a lifetime diagnosis of bipolar or psychotic disorder.
- A history or active presence of clinically important medical disease.
- Additional criteria apply.
Trial locations and contacts
37 sites in 1 country.
37 sites in 1 country
United States37 sites
Study site
Atlanta, Georgia, 30308
Study site
Austin, Texas, 78756
Study site
Beachwood, Ohio, 44122
Study site
Birmingham, Alabama, 35226
Study site
Bradenton, Florida, 34208
Study site
Brooklyn, New York, 11235
Study site
Brown Deer, Wisconsin, 53223
Study site
Cherry Hill, New Jersey, 08002
Study site
Chicago, Illinois, 60634
Study site
Dayton, Ohio, 45408
Study site
Hilton Head Island, South Carolina, 29926
Study site
Houston, Texas, 77007
Study site
Idaho Falls, Idaho, 83404
Study site
Indianapolis, Indiana, 46202
Study site
Little Rock, Arkansas, 72223
Study site
Miami, Florida, 33133
Study site
Minot, North Dakota, 58701
Study site
New London, Connecticut, 06320
Study site
Oklahoma City, Oklahoma, 73118
Study site
Omaha, Nebraska, 68131
Study site
Palo Alto, California, 94305
Study site
Philadelphia, Pennsylvania, 19131
Study site
Richmond, Virginia, 23229
Study site
Richmond, Virginia, 23230
Study site
Rockville, Maryland, 20852
Study site
San Diego, California, 92103
Study site
Sandy Springs, Georgia, 30328
Study site
Savannah, Georgia, 31406
Study site
Seattle, Washington, 98105
Study site
Shreveport, Louisiana, 71101
Study site
Smyrna, Georgia, 30080
Study site
Springdale, Arkansas, 72762
Study site
Tampa, Florida, 33613
Study site
Terre Haute, Indiana, 47802
Study site
Toledo, Ohio, 43623
Study site
Tulsa, Oklahoma, 74135
Study site
Winter Park, Florida, 32789
About this study
Official title: A Multicenter, Randomized, 8-week, Double-blind, Placebo-controlled Study Followed by a 6-month Open-label Extension to Evaluate the Efficacy and Safety of DVS SR in Peri- and Postmenopausal Women With Major Depressive Disorder
Desvenlafaxine succinate (DVS) is a potent and selective serotonin and norepinephrine reuptake inhibitor (SNRI). The sustained-release (SR) formulation, DVS SR, is being studied in the development program for the treatment of major depressive disorder (MDD), for vasomotor symptoms (VMS) associated with menopause, and for pain associated with peripheral diabetic neuropathy, as well as for the treatment of fibromyalgia syndrome. This study will investigate the safety, efficacy, and tolerability of DVS SR in women with MDD who are peri- and postmenopausal.
- Conditions
- Depression, Depressive Disorder, Depressive Disorder, Major
- Being tested
- Desvenlafaxine administered as a succinate salt in a sustained-release form (DVS SR), Placebo
- Keywords
- Major Depressive Disorder, vasomotor symptoms, menopause, diabetic neuropathy, fibromyalgia
- Medical subject headings
- Depression, Depressive Disorder, Depressive Disorder, Major, Diabetic Neuropathies, Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Desvenlafaxine administered as a succinate salt in a sustained-release form (DVS SR)Drug
DVS-SR 50-200mg, daily (QD), tablet form, treatment period up to 34 weeks
PlaceboDrug
Placebo, daily (QD), tablet form, treatment period up to 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: Desvenlafaxine administered as a succinate salt in a sustained-release form (DVS SR) |
| B | 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 in Hamilton Psychiatric Rating Scale for Depression (HAM-D17) Score From Baseline to Week 8.
HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on a 0 to 2-4 scale (0=none/absent and 4=most severe) with a maximum total score of 50. Change= 8 week adjusted mean HAM-D17 minus baseline adjusted mean HAM-D17
Measured: Baseline to 8 weeks
Secondary outcomes (12)
Percentage of Patients With Each Clinical Global Impression Improvement (CGI-I) Score
CGI-I is a global rating scale that measures disease improvement. Using a 7-point scale, the clinician rates how much the patient's illness has improved or worsened relative to the baseline status (1= very much improved; 7= very much worse).
Measured: 8 weeks
Percentage of Patients Achieving Remission
Remission is defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score of ≤ 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on a 0 to 2-4 scale (0=none/absent and 4=most severe) with a maximum total score of 50.
Measured: 8 weeks
Percentage of Patients Achieving Response to Treatment
A response is defined as ≥ 50% decrease from baseline on Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on a 0 to 2-4 scale (0=none/absent and 4=most severe) with a maximum total score of 50.
Measured: 8 weeks
Change in Hamilton Psychiatric Rating Scale for Anxiety (HAM-A) Score From Baseline to Week 8
The HAM-A is a standardized, clinician-administered rating scale that assesses 14 items characteristically associated with major anxiety disorders. Items are scaled 0 - 4 (0=none and 4=very severe), with a maximum total score of 56. Change= 8 week adjusted mean HAM-A score minus baseline adjusted mean score.
Measured: Baseline to 8 weeks
Change in Dimension Health State EuroQol (EQ-5D) Score From Baseline to Week 8
EQ-5D is a standardized, subject-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme problems) and a single index value characterizing current health status using a 100-point visual analog scale (0=worst, 100=best). EQ-5D summary index is obtained with a formula that weights each level of the dimensions. The index-based score is interpreted along a continuum of 0 (death) to 1 (perfect health). Change=8 week score minus baseline score.
Measured: Baseline to 8 weeks
Change in Hamilton Psychiatric Rating Scale for Depression (HAM-D17) Score From Open Label Baseline to 6 Months
HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on a 0 to 2-4 scale (0=none/absent and 4=most severe) with a maximum total s core of 50. Change= Final Evaluation mean HAM-D17 minus baseline mean HAM-D17.
Measured: open label baseline and 6 months
Clinical Global Impression Improvement (CGI-I) Score
CGI-I is a global rating scale that measures disease improvement. Using a 7-point scale the clinician rates how much the patient's illness has improved or worsened relative to the baseline status (1= very much improved; 7= very much worse)
Measured: 6 months
Percentage of Patients Achieving Remission
Remission is defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score of ≤ 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on a 0 to 2-4 scale (0=none/absent and 4=most severe) with a maximum total s core of 50.
Measured: 6 months
Percentage of Patients Achieving a Response to Treatment
A responder is defined as a patient with ≥ 50% decrease from baseline on Hamilton Psychiatric Rating Scale for Depression - 17-item (HAM-D17) score. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on a 0 to 2-4 scale (0=none/absent and 4=most severe) with a maximum total score of 50.
Measured: 6 months
Change in Hamilton Psychiatric Rating Scale for Anxiety (HAM-A) Score From Open Label Baseline to 6 Months
The HAM-A is a standardized, clinician-administered rating scale that assesses 14 items characteristically associated with major anxiety disorders. Items are scaled 0 - 4 (0=none and 4=very severe), with a maximum total score of 56. Change= Final Evaluation mean HAM-A score minus baseline mean score.
Measured: open label baseline to 6 months
Change in Dimension Health State EuroQol (EQ-5D) Score From Open Label Baseline to 6 Months
EQ-5D is a standardized, subject-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme problems) and a single index value characterizing current health status using a 100-point visual analog scale (0=worst, 100=best). EQ-5D summary index is obtained with a formula that weights each level of the dimensions. The index-based score is interpreted along a continuum of 0 (death) to 1 (perfect health). Change=8 week score minus baseline score.
Measured: open label baseline to 6 months
Discontinuation-Emergent Signs and Symptoms (DESS) Total Score
DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. The DESS total score is the sum of the number of "new symptoms" and "old (but worse) symptoms" (1) and 0 for "old and unchanged symptom," "absent," or "old symptom but improved" for a total possible range of 0 to 43. A higher score indicates more symptoms.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2006 (estimated)
- Study startSep 2006
- Primary completionNov 2007
- Study completionJul 2008
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 (2)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 381 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Wyeth is now a wholly owned subsidiary of Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00369343
- Sponsor's protocol ID
- 3151A1-403
- Status last verified
- Apr 2012
- First submitted
- 25 Aug 2006
- Last updated
- 7 May 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Kornstein SG, Clayton AH, Bao W, Guico-Pabia CJ. A pooled analysis of the efficacy of desvenlafaxine for the treatment of major depressive disorder in perimenopausal and postmenopausal women. J Womens Health (Larchmt). 2015 Apr;24(4):281-90. doi: 10.1089/jwh.2014.4900.
PubMed 25860107Kornstein SG, Jiang Q, Reddy S, Musgnung JJ, Guico-Pabia CJ. Short-term efficacy and safety of desvenlafaxine in a randomized, placebo-controlled study of perimenopausal and postmenopausal women with major depressive disorder. J Clin Psychiatry. 2010 Aug;71(8):1088-96. doi: 10.4088/JCP.10m06018blu.
PubMed 20797382
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, 8-week, Double-blind, Placebo-controlled Study Followed by a 6-month Open-label Extension to Evaluate the Efficacy and Safety of DVS SR in Peri- and Postmenopausal Women With Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT00369343
- Acronym / sponsor ID
- 3151A1-403
- Conditions
- Depression, Depressive Disorder, Depressive Disorder, Major
- Keywords
- Major Depressive Disorder, vasomotor symptoms, menopause, diabetic neuropathy, fibromyalgia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 381 participants (actual)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Nov 2007 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 29 Aug 2006 (estimated)
- Results
- Posted 7 May 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Desvenlafaxine succinate (DVS) is a potent and selective serotonin and norepinephrine reuptake inhibitor (SNRI). The sustained-release (SR) formulation, DVS SR, is being studied in the development program for the treatment of major depressive disorder (MDD), for vasomotor symptoms (VMS) associated with menopause, and for pain associated with peripheral diabetic neuropathy, as well as for the treatment of fibromyalgia syndrome. This study will investigate the safety, efficacy, and tolerability of DVS SR in women with MDD who are peri- and postmenopausal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Desvenlafaxine administered as a succinate salt in a sustained-release form (DVS SR) |
| B | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Peri- and postmenopausal women between the ages of 40 and 70 years, inclusive.
- A primary diagnosis of MDD, single or recurrent episode, without psychotic features using the modified International Neuropsychiatric Interview (MINI).
- Montgomery-Asberg Depression Rating Scale (MADRS) total score > or = 22 at the screening and baseline visit.
Key exclusion criteria (4 listed)
- Use of oral estrogen-, progestin-, androgen-, or Selective Estrogen Receptor Modulator (SERM)-containing drug products 8 weeks before baseline.
- Current (within 12 months) psychoactive substance abuse or dependence (including alcohol), manic episode, post-traumatic stress disorder, obsessive-compulsive disorder, or a lifetime diagnosis of bipolar or psychotic disorder.
- A history or active presence of clinically important medical disease.
- Additional criteria 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 administered as a succinate salt in a sustained-release form (DVS SR)DVS-SR 50-200mg, daily (QD), tablet form, treatment period up to 34 weeks | Drug | A |
| PlaceboPlacebo, daily (QD), tablet form, treatment period up to 8 weeks | Drug | B |
Primary outcome
Change in Hamilton Psychiatric Rating Scale for Depression (HAM-D17) Score From Baseline to Week 8.
Time frame: Baseline to 8 weeks
HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on a 0 to 2-4 scale (0=none/absent and 4=most severe) with a maximum total score of 50. Change= 8 week adjusted mean HAM-D17 minus baseline adjusted mean HAM-D17
12 secondary outcomes
Percentage of Patients With Each Clinical Global Impression Improvement (CGI-I) Score
Time frame: 8 weeks
Percentage of Patients Achieving Remission
Time frame: 8 weeks
Percentage of Patients Achieving Response to Treatment
Time frame: 8 weeks
Change in Hamilton Psychiatric Rating Scale for Anxiety (HAM-A) Score From Baseline to Week 8
Time frame: Baseline to 8 weeks
Change in Dimension Health State EuroQol (EQ-5D) Score From Baseline to Week 8
Time frame: Baseline to 8 weeks
Change in Hamilton Psychiatric Rating Scale for Depression (HAM-D17) Score From Open Label Baseline to 6 Months
Time frame: open label baseline and 6 months
Clinical Global Impression Improvement (CGI-I) Score
Time frame: 6 months
Percentage of Patients Achieving Remission
Time frame: 6 months
Percentage of Patients Achieving a Response to Treatment
Time frame: 6 months
Change in Hamilton Psychiatric Rating Scale for Anxiety (HAM-A) Score From Open Label Baseline to 6 Months
Time frame: open label baseline to 6 months
Change in Dimension Health State EuroQol (EQ-5D) Score From Open Label Baseline to 6 Months
Time frame: open label baseline to 6 months
Discontinuation-Emergent Signs and Symptoms (DESS) Total Score
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25860107Kornstein SG, Clayton AH, Bao W, Guico-Pabia CJ. A pooled analysis of the efficacy of desvenlafaxine for the treatment of major depressive disorder in perimenopausal and postmenopausal women. J Womens Health (Larchmt). 2015 Apr;24(4):281-90. doi: 10.1089/jwh.2014.4900.
- Derived from this study: PubMed 20797382Kornstein SG, Jiang Q, Reddy S, Musgnung JJ, Guico-Pabia CJ. Short-term efficacy and safety of desvenlafaxine in a randomized, placebo-controlled study of perimenopausal and postmenopausal women with major depressive disorder. J Clin Psychiatry. 2010 Aug;71(8):1088-96. doi: 10.4088/JCP.10m06018blu.
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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.
Medical Monitor study director
Wyeth is now a wholly owned subsidiary of Pfizer
37 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 administered as a succinate salt in a sustained-release form (DVS SR) in people with Depression and Depressive Disorder, run by Wyeth is now a wholly owned subsidiary of Pfizer at 37 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 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 7 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 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 7 May 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 in Hamilton Psychiatric Rating Scale for Depression (HAM-D17) Score From Baseline to Week 8. (time frame: Baseline to 8 weeks). 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 NCT00369343, which also lists 2 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 7 May 2012.