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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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:

  1. Outpatient men and women at least 18 years of age.
  2. 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.
  3. Have a HAM D17 total score ≥20 at the screening and baseline (study day 1) visit.

Primary Exclusion Criteria:

  1. Treatment with DVS SR at any time in the past.
  2. 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.
  3. 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

Other trials in India

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

Other trials in China

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

Other trials in South Korea

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

Other trials in Taiwan

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.

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 groups in NCT00445679
Study groupRoleWhat they receive
AExperimentalDVS SR 50mg/day
Receives: Drug: DVS SR
BExperimentalDVS SR 100mg/day
Receives: Drug: DVS SR
CExperimentalDVS SR 200mg/day
Receives: Drug: DVS SR
DActive comparatorParoxetine 20mg/day
Receives: Drug: Paroxetine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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.

  1. First posted9 Mar 2007 (estimated)
  2. Study startJul 2007
  3. Primary completionFeb 2009
  4. Study completionFeb 2009

Resources

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)
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

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?

On the ClinicalTrials.gov record for NCT00445679.

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.

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