Major Depressive DisorderPhase 3NCT00531622
An Eight-week Study of Saredutant and Escitalopram as Combination Treatment for Major Depressive Disorder
A Phase 3 study testing saredutant (SR48968) and escitalopram in people with Major Depressive Disorder, run by Sanofi at 6 sites in 6 countries.
Trial summary
The main purpose of this study is to evaluate the efficacy of saredutant 100mg once daily in combination with escitalopram 10mg once daily compared to saredutant placebo in combination with escitalopram 10mg once daily in patients with major depressive disorder. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- saredutant (SR48968) and escitalopram
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 643 participants
- Where
- 6 sitesin 6 countries
- Study dates
- Sep 2007to Jan 2009
- Phase
- Phase 3
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Outpatients with recurrent Major Depressive Disorder
Who cannot join
- Symptoms of current depressive episode for less than 30 days or more than 2 years
- Mild depression, as measured by standard clinical research scales
- Significant suicide risk
- Lack of sexual activity (including masturbation)
- Other psychiatric conditions that would obscure the results of the study
- History of failure to respond to antidepressant treatment
- Pregnancy or breast-feeding
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
6 sites in 6 countries.
6 sites in 6 countries
United States1 site
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, 08807
About this study
Official title: An Eight-week, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Saredutant 100 mg Once Daily in Combination With Escitalopram 10 mg Once Daily in Patients With Major Depressive Disorder
The main purpose of this study is to evaluate the efficacy of saredutant 100mg once daily in combination with escitalopram 10mg once daily compared to saredutant placebo in combination with escitalopram 10mg once daily in patients with major depressive disorder. This study also includes a double-placebo group (saredutant placebo in combination with escitalopram placebo).
- Conditions
- Major Depressive Disorder
- Being tested
- saredutant (SR48968), escitalopram, placebo
- Keywords
- Depression, Major Depressive Episode, Antidepressant
- 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.
saredutant (SR48968)Drug
oral administration, capsules
escitalopramDrug
oral administration, capsules
placeboDrug
oral administration, capsules
| Study group | Role | What they receive |
|---|---|---|
| Saredudant/Escitalopram | Experimental | Saredutant 100 mg and Escitalopram 10 mg once daily for a maximum of 8 weeks Receives: Drug: saredutant (SR48968); Drug: escitalopram |
| Placebo and Escitalopram | Active comparator | Placebo for saredutant and Escitalopram 10 mg once daily for a maximum of 8 weeks Receives: Drug: escitalopram; Drug: placebo |
| Placebo | Placebo comparator | Placebo for saredutant and Placebo for Escitalopram once daily for one week during the screening phase and for a maximum of 8 weeks during the active phase Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to Day 56 in Hamilton depression rating scale (HAM-D) total score
Measured: Baseline, Day 56
Change from Baseline to Day 56 in the CGI-S Severity of Illness score
Measured: Baseline, Day 56
Secondary outcomes (3)
Change from baseline to Day 56 in the Clinical Global Impression (CGI) severity of illness score
Measured: Baseline, Day 56
Change from baseline to Day 56 in HAM-D depressed mood item scores.
Measured: Baseline, Day 56
Percentage of patients demonstrating a treatment response
response is defined as a reduction of at least 50% in HAM-D total score between baseline and any post-baseline assessment
Measured: Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2007 (estimated)
- Study startSep 2007
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- 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
- 643 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ICD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00531622
- Sponsor's protocol ID
- EFC10290
- Other IDs
- EudraCT 2007-003159-36
- Status last verified
- Apr 2016
- First submitted
- 18 Sep 2007
- Last updated
- 24 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Eight-week, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Saredutant 100 mg Once Daily in Combination With Escitalopram 10 mg Once Daily in Patients With Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT00531622
- Acronym / sponsor ID
- EFC10290
- Conditions
- Major Depressive Disorder
- Keywords
- Depression, Major Depressive Episode, Antidepressant
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 643 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 19 Sep 2007 (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.
The main purpose of this study is to evaluate the efficacy of saredutant 100mg once daily in combination with escitalopram 10mg once daily compared to saredutant placebo in combination with escitalopram 10mg once daily in patients with major depressive disorder. This study also includes a double-placebo group (saredutant placebo in combination with escitalopram placebo).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Saredudant/Escitalopram | Experimental | Drug: saredutant (SR48968), Drug: escitalopramSaredutant 100 mg and Escitalopram 10 mg once daily for a maximum of 8 weeks |
| Placebo and Escitalopram | Active comparator | Drug: escitalopram, Drug: placeboPlacebo for saredutant and Escitalopram 10 mg once daily for a maximum of 8 weeks |
| Placebo | Placebo comparator | Drug: placeboPlacebo for saredutant and Placebo for Escitalopram once daily for one week during the screening phase and for a maximum of 8 weeks during the active phase |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Outpatients with recurrent Major Depressive Disorder
Key exclusion criteria (8 listed)
- Symptoms of current depressive episode for less than 30 days or more than 2 years
- Mild depression, as measured by standard clinical research scales
- Significant suicide risk
- Lack of sexual activity (including masturbation)
- Other psychiatric conditions that would obscure the results of the study
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 |
|---|---|---|
| saredutant (SR48968)oral administration, capsules | Drug | Saredudant/Escitalopram |
| escitalopramoral administration, capsules | Drug | Placebo and Escitalopram, Saredudant/Escitalopram |
| placebooral administration, capsules | Drug | Placebo, Placebo and Escitalopram |
Primary outcome
Change from baseline to Day 56 in Hamilton depression rating scale (HAM-D) total score
Time frame: Baseline, Day 56
Change from Baseline to Day 56 in the CGI-S Severity of Illness score
Time frame: Baseline, Day 56
3 secondary outcomes
Change from baseline to Day 56 in the Clinical Global Impression (CGI) severity of illness score
Time frame: Baseline, Day 56
Change from baseline to Day 56 in HAM-D depressed mood item scores.
Time frame: Baseline, Day 56
Percentage of patients demonstrating a treatment response
Time frame: Day 56
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 24 May 2016.
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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.
ICD study director
Sanofi
6 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing saredutant (SR48968) and escitalopram in people with Major Depressive Disorder, run by Sanofi at 6 sites in 6 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 1 inclusion and 8 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 24 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Argentina, Finland, France, Mexico and 1 more country. 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?
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 to Day 56 in Hamilton depression rating scale (HAM-D) total score (time frame: Baseline, Day 56). The study lists 2 primary outcomes in all. 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 24 May 2016.