Depressive Disorder, MajorPhase 3NCT00445679
Paroxetine-referenced Study Evaluating Three Doses of DVS SR in Outpatients With MDD
A Phase 3 study testing DVS SR and Paroxetine in people with Depressive Disorder, Major, run by Wyeth is now a wholly owned subsidiary of Pfizer at 43 sites in 4 countries.
Trial summary
This study will assess the safety, tolerability and efficacy of desvenlafaxine succinate sustained release (DVS SR) in subjects 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?
- DVS SR and Paroxetine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 807 participants
- Where
- 43 sitesin 4 countries
- Study dates
- Jul 2007to Feb 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Primary Inclusion Criteria:
- Outpatient men and women at least 18 years of age.
- Have a primary diagnosis of MDD based on the criteria in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM IV), single or recurrent episode, without psychotic features.
- Have a HAM D17 total score ≥20 at the screening and baseline (study day 1) visit.
Primary Exclusion Criteria:
- Treatment with DVS SR at any time in the past.
- 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.
Trial locations and contacts
43 sites in 4 countries.
43 sites in 4 countries
India16 sites
Study site
Andhra Pradesh, 500 038
Study site
Andhra Pradesh, 500034
Study site
Andhra Pradesh, 517 507
Study site
Andhra Pradesh, 530 002
Study site
Chandigarh, 160012
Study site
Gujarat, 380006
Study site
Gujarat, 380013
Study site
Karnataka, 575 001
Study site
Karnataka, 575018
Study site
Maharashtra, 400 012
Study site
Maharashtra, 400 026
Study site
Maharashtra, 411001
Study site
Mumbai Maharashtra, H19400 022
Study site
New Delhi, 110002
Study site
Punjab, 141001
Study site
Uttar Pradesh, 226003
China11 sites
Study site
Beijing, 100083
Study site
Beijing, 100088
Study site
Guangdong Province, 510370
Study site
Hunan Province, 410011
Study site
Jiangsu Province, 210029
Study site
Shanghai, 200030
Study site
Shanghai, 200065
Study site
Shanxi Province, 710032
Study site
Sichuan Province, 610041
Study site
Yunnan Province, 650032
Study site
Zhejiang Province, 310003
South Korea9 sites
Study site
Incheon, 400-711
Study site
Seoul, 110-744
Study site
Seoul, 135-710
Study site
Seoul, 135-720
Study site
Seoul, 137-701
Study site
Seoul, 138-736
Study site
Seoul, 140-757
Study site
Seoul, 150-719
Study site
Seoul, 158-710
Taiwan7 sites
Study site
Chang-hua, ROC 500
Study site
Kaohsiung City, ROC 80708
Study site
Taipei, ROC 100
Study site
Taipei, ROC 111
Study site
Taipei, ROC 112
Study site
Taipei, ROC 114
Study site
Taipei, ROC 220
About this study
Official title: A Multicenter, Randomized, Double-blind, Paroxetine-referenced, Parallel-group Study to Evaluate the Safety, Efficacy, and Tolerability of 3 Fixed Doses (50mg, 100mg, AND 200mg) of Desvenlafaxine Succinate Sustained-release Tablets in Adult Outpatients With Major Depressive Disorder
This study will assess the safety, tolerability and efficacy of desvenlafaxine succinate sustained release (DVS SR) in subjects with major depressive disorder.
Read the detailed description
The primary objective of this study is to investigate the efficacy, safety and tolerability of desvenlafaxine succinate sustained release (DVS SR) in Chinese, Taiwanese, South Korean, and Indian subjects with major depressive disorder (MDD) receiving daily doses of 50 mg, 100 mg, or 200 mg. The secondary objective is to obtain additional information regarding the efficacy of DVS SR in subjects with MDD receiving daily doses of 50 mg, 100 mg, or 200 mg. Additional objectives include obtaining general and functional quality of life outcome data.
- Conditions
- Depressive Disorder, Major
- Being tested
- DVS SR, Paroxetine
- Keywords
- major depressive disorder, MDD, 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.
DVS SRDrug
Arm 1: 50mg DVS SR tablet, QD, 8 weeks treatment with 2 week taper Arm 2: 100mg DVS SR tablet, QD, 8 weeks treatment with 2 week taper Arm 3: 200mg DVS SR tablet, QD, 8 weeks treatment with 2 week taper
ParoxetineDrug
20 mg Paroxetine capsule, QD, 8 weeks treatment with 2 week taper
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | DVS SR 50mg/day Receives: Drug: DVS SR |
| B | Experimental | DVS SR 100mg/day Receives: Drug: DVS SR |
| C | Experimental | DVS SR 200mg/day Receives: Drug: DVS SR |
| D | Active comparator | Paroxetine 20mg/day Receives: Drug: Paroxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Responders With a 50% or Greater Decrease From Baseline on the Hamilton Rating Scale for Depression, 17-item (HAM-D17)
HAM-D17 is 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: 8 weeks
Secondary outcomes (6)
Clinical Global Impressions Scale-Improvement (CGI-I) Scores
CGI-I is a global rating scale that measures disease improvement. Using a 7-point scale, the clinician rates how much the subject's illness has improved or worsened relative to the baseline status (1= very much improved; 7= very much worse).
Measured: 8 weeks
Clinical Global Impressions Scale-Severity of Illness (CGI-S) Scores
CGI-S is a global rating scale that measures the severity of a subject's disease. Using a 7-point scale, the clinician rates the severity of the patient's mental illness at the time of the assessment, relative to the clinician's experience with subjects who have the same diagnosis (1= normal, not at all ill; 7= among the most extremely ill).
Measured: 8 weeks
Montgomery and Asberg Depression Rating Scale (MADRS) Total Score Mean Change From Baseline
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 8 weeks
Visual Analog Scale-pain Intensity (VAS-PI) Score Mean Change From Baseline
The VAS-PI is a self-rated visual analog scale for the assessment of pain. Scores on the VAS-PI range from 0 (no pain) to 10 (worst possible pain). A decrease in VAS-PI overall scores indicates a subject's assessment of an improvement in pain.
Measured: 8 weeks
Hamilton Rating Scale for Depression, 6-item (HAM-D6) Score Mean Change From Baseline
HAM-D6: standardized, clinician-administered rating scale is a subset of the HAM-D17 that assesses 6 items associated with major depression. The scale uses HAM-D17 items 1, 2, 7, 8, 10 and 13. Item 13 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). Total score ranges from 0 to 22; higher score indicates more depression.
Measured: 8 weeks
Covi Anxiety Scale Score Mean Change From Baseline
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, 5 = Very much. Total score ranges from 3 to 15; higher score indicates more anxiety.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2007 (estimated)
- Study startJul 2007
- Primary completionFeb 2009
- Study completionFeb 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.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 807 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 PfizerTrial Manager, Principal investigator, For China: medinfo@wyeth.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00445679
- Sponsor's protocol ID
- 3151A1-336
- Status last verified
- Oct 2013
- First submitted
- 6 Mar 2007
- Last updated
- 4 Nov 2013
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Paroxetine-referenced, Parallel-group Study to Evaluate the Safety, Efficacy, and Tolerability of 3 Fixed Doses (50mg, 100mg, AND 200mg) of Desvenlafaxine Succinate Sustained-release Tablets in Adult Outpatients With Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT00445679
- Acronym / sponsor ID
- 3151A1-336
- Conditions
- Depressive Disorder, Major
- Keywords
- major depressive disorder, MDD, depression
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 807 participants (actual)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 9 Mar 2007 (estimated)
- Results
- Posted 4 Nov 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess the safety, tolerability and efficacy of desvenlafaxine succinate sustained release (DVS SR) in subjects with major depressive disorder.
Detailed description
The primary objective of this study is to investigate the efficacy, safety and tolerability of desvenlafaxine succinate sustained release (DVS SR) in Chinese, Taiwanese, South Korean, and Indian subjects with major depressive disorder (MDD) receiving daily doses of 50 mg, 100 mg, or 200 mg. The secondary objective is to obtain additional information regarding the efficacy of DVS SR in subjects with MDD receiving daily doses of 50 mg, 100 mg, or 200 mg. Additional objectives include obtaining general and functional quality of life outcome data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: DVS SRDVS SR 50mg/day |
| B | Experimental | Drug: DVS SRDVS SR 100mg/day |
| C | Experimental | Drug: DVS SRDVS SR 200mg/day |
| D | Active comparator | Drug: ParoxetineParoxetine 20mg/day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| DVS SRArm 1: 50mg DVS SR tablet, QD, 8 weeks treatment with 2 week taper Arm 2: 100mg DVS SR tablet, QD, 8 weeks treatment with 2 week taper Arm 3: 200mg DVS SR tablet, QD, 8 weeks treatment with 2 week taper | Drug | A, B, C |
| Paroxetine20 mg Paroxetine capsule, QD, 8 weeks treatment with 2 week taper | Drug | D |
Primary outcome
Percentage of Responders With a 50% or Greater Decrease From Baseline on the Hamilton Rating Scale for Depression, 17-item (HAM-D17)
Time frame: 8 weeks
HAM-D17 is 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.
6 secondary outcomes
Clinical Global Impressions Scale-Improvement (CGI-I) Scores
Time frame: 8 weeks
Clinical Global Impressions Scale-Severity of Illness (CGI-S) Scores
Time frame: 8 weeks
Montgomery and Asberg Depression Rating Scale (MADRS) Total Score Mean Change From Baseline
Time frame: Baseline and 8 weeks
Visual Analog Scale-pain Intensity (VAS-PI) Score Mean Change From Baseline
Time frame: 8 weeks
Hamilton Rating Scale for Depression, 6-item (HAM-D6) Score Mean Change From Baseline
Time frame: 8 weeks
Covi Anxiety Scale Score Mean Change From Baseline
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
Trial Manager principal investigator
For China: medinfo@wyeth.com
43 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DVS SR and Paroxetine in people with Depressive Disorder, Major, run by Wyeth is now a wholly owned subsidiary of Pfizer at 43 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 4 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in India, China, South Korea, Taiwan. 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. 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 4 Nov 2013). 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?
Percentage of Responders With a 50% or Greater Decrease From Baseline on the Hamilton Rating Scale for Depression, 17-item (HAM-D17) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Nov 2013.