Depressive Disorder, MajorPhase 4NCT00644982
A Comparison of Sertraline Versus Venlafaxine XR in the Treatment of Major Depression
A Phase 4 study testing sertraline and venlafaxine XR in people with Depressive Disorder, Major, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 14 sites in 2 countries.
Trial summary
To assess the comparative efficacy of sertraline versus venlafaxine XR on measures of quality of life. 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?
- sertraline and venlafaxine XR
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 163 participants
- Where
- 14 sitesin 2 countries
- Study dates
- Oct 2002to Sep 2003
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Primary diagnosis of DSM-IV Major Depressive Disorder, single episode or recurrent, without psychotic features. Additional DSM-IV Axis I diagnoses will be permitted only if they are identified as secondary diagnoses.
- Hamilton-Depression rating scale (HAM-D; 17 item) total score ≥18 and HAMD item 1 (depressed mood) score ≥2.
Who cannot join
- Use of an antidepressant within 2 weeks of baseline (4 weeks for fluoxetine)
- Current or past diagnosis of bipolar disorder or any psychotic disorder.
Trial locations and contacts
14 sites in 2 countries.
14 sites in 2 countries
Australia7 sites
Pfizer Investigational Site
Box Hill, Victoria, 3128
Pfizer Investigational Site
Cairns, Queensland, 4870
Pfizer Investigational Site
Everton Park, Queensland, 4053
Pfizer Investigational Site
Heidelberg, Victoria, 3084
Pfizer Investigational Site
North Cairns, Queensland, 4870
Pfizer Investigational Site
WEST Heidelberg, Victoria, 3081
Pfizer Investigational Site
West Perth, Western Australia, 6005
Turkey (Türkiye)7 sites
Pfizer Investigational Site
Adana
Pfizer Investigational Site
Ankara
Pfizer Investigational Site
Diyarbakır
Pfizer Investigational Site
Istanbul
Pfizer Investigational Site
Izmir
Pfizer Investigational Site
İzmit
Pfizer Investigational Site
Malatya
About this study
Official title: A Multicenter Randomized, Double-Blind, Parallel-Group Study of Sertraline Versus Venlafaxine XR in the Acute Treatment of Outpatients With Major Depressive Disorder
To assess the comparative efficacy of sertraline versus venlafaxine XR on measures of quality of life.
- Conditions
- Depressive Disorder, Major
- Being tested
- sertraline, venlafaxine XR
- 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.
sertralineDrug
Also called Zoloft
Flexibly-titrated 50 mg tablets, 50-150 mg/day and venlafaxine placebo orally for 10 weeks.
venlafaxine XRDrug
Flexibly-titrated 75 mg capsules, 75-225mg/day and sertraline placebo orally for 10 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Sertaline group | Experimental | Not described Receives: Drug: sertraline |
| Venlafaxine group | Active comparator | Not described Receives: Drug: venlafaxine XR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in QOL, measured using the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q).
Measured: Weeks 1, 2, 3, 4, 6, 8, 9 and 10.
Secondary outcomes (10)
Change from baseline in the 17-item Hamilton-Depression Rating Scale (HAM-D) including response (≥50% reduction in HAM-D total score from baseline) and remission (HAM-D total score ≤7) rates.
Measured: Weeks 1, 2, 3, 4, 6, 8, 9 and 10.
The 17-item Hamilton-Depression Rating Scale response rates at endpoint (week 8).
Measured: Week 8
CGI response rate at endpoint (week 8).
Measured: Week 8
Change from baseline in the CGI-Severity Scale (CGI-S).
Measured: Weeks 1, 2, 3, 4, 6, 8, 9 and 10.
Change from baseline in the Hamilton Anxiety Scale (HAM-A).
Measured: Weeks 1, 2, 3, 4, 6, 8, 9 and 10.
Change from baseline in the Endicott Work Productivity Scale (EWPS).
Measured: Weeks 1, 8, 9, 10
Change from baseline in the Visual Analogue Scale (VAS) for Depression.
Measured: Weeks 1, 2, 3, 4, 6, 8, 9 and 10.
Change from baseline in the Visual Analogue Scale (VAS) for Overall Assessment of Pain.
Measured: Weeks 1, 2, 3, 4, 6, 8, 9 and 10.
Hamilton-Depression Rating Scale remission rates at endpoint (week 8).
Measured: Week 8
Change from baseline in the Clinical Global Impression-Improvement Scale.
Measured: Weeks 1, 2, 3, 4, 6, 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2008 (estimated)
- Study startOct 2002
- Study completionSep 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00644982
- Sponsor's protocol ID
- A0501066
- Status last verified
- Jan 2021
- First submitted
- 24 Mar 2008
- Last updated
- 27 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized, Double-Blind, Parallel-Group Study of Sertraline Versus Venlafaxine XR in the Acute Treatment of Outpatients With Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT00644982
- Acronym / sponsor ID
- A0501066
- Conditions
- Depressive Disorder, Major
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2002
- Study completion
- Sep 2003 (actual)
- First posted
- 27 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the comparative efficacy of sertraline versus venlafaxine XR on measures of quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sertaline group | Experimental | Drug: sertraline |
| Venlafaxine group | Active comparator | Drug: venlafaxine XR |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Primary diagnosis of DSM-IV Major Depressive Disorder, single episode or recurrent, without psychotic features. Additional DSM-IV Axis I diagnoses will be permitted only if they are identified as secondary diagnoses.
- Hamilton-Depression rating scale (HAM-D; 17 item) total score ≥18 and HAMD item 1 (depressed mood) score ≥2.
Key exclusion criteria (2 listed)
- Use of an antidepressant within 2 weeks of baseline (4 weeks for fluoxetine)
- Current or past diagnosis of bipolar disorder or any psychotic disorder.
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 |
|---|---|---|
| sertralineAlso: ZoloftFlexibly-titrated 50 mg tablets, 50-150 mg/day and venlafaxine placebo orally for 10 weeks. | Drug | Sertaline group |
| venlafaxine XRFlexibly-titrated 75 mg capsules, 75-225mg/day and sertraline placebo orally for 10 weeks. | Drug | Venlafaxine group |
Primary outcome
Change from baseline in QOL, measured using the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q).
Time frame: Weeks 1, 2, 3, 4, 6, 8, 9 and 10.
10 secondary outcomes
Change from baseline in the 17-item Hamilton-Depression Rating Scale (HAM-D) including response (≥50% reduction in HAM-D total score from baseline) and remission (HAM-D total score ≤7) rates.
Time frame: Weeks 1, 2, 3, 4, 6, 8, 9 and 10.
The 17-item Hamilton-Depression Rating Scale response rates at endpoint (week 8).
Time frame: Week 8
CGI response rate at endpoint (week 8).
Time frame: Week 8
Change from baseline in the CGI-Severity Scale (CGI-S).
Time frame: Weeks 1, 2, 3, 4, 6, 8, 9 and 10.
Change from baseline in the Hamilton Anxiety Scale (HAM-A).
Time frame: Weeks 1, 2, 3, 4, 6, 8, 9 and 10.
Change from baseline in the Endicott Work Productivity Scale (EWPS).
Time frame: Weeks 1, 8, 9, 10
Change from baseline in the Visual Analogue Scale (VAS) for Depression.
Time frame: Weeks 1, 2, 3, 4, 6, 8, 9 and 10.
Change from baseline in the Visual Analogue Scale (VAS) for Overall Assessment of Pain.
Time frame: Weeks 1, 2, 3, 4, 6, 8, 9 and 10.
Hamilton-Depression Rating Scale remission rates at endpoint (week 8).
Time frame: Week 8
Change from baseline in the Clinical Global Impression-Improvement Scale.
Time frame: Weeks 1, 2, 3, 4, 6, 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2021.
- 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
14 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing sertraline and venlafaxine XR in people with Depressive Disorder, Major, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 14 sites in 2 countries.
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 2 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 27 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Australia, Turkey (Türkiye). 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 QOL, measured using the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q). (time frame: Weeks 1, 2, 3, 4, 6, 8, 9 and 10.). 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 27 Jan 2021.