Depressive DisorderPhase 3NCT00415142
An Eight-week Study Evaluating the Efficacy of a 100mg Dose of Saredutant Once Daily, in Elderly Patients With Major Depressive Disorder
A Phase 3 study testing saredutant (SR48968) and escitalopram in people with Depressive Disorder, run by Sanofi at 8 sites in 8 countries.
Trial summary
The purpose of the study is to evaluate the efficacy of saredutant in the treatment of Major Depressive Disorder in elderly patients.To evaluate the tolerability, safety and efficacy on disability and quality of life in patients with major depressive disorder.To evaluate safety and tolerability of 24 weeks of… Read more about this study
- Who is it for?
- Ages 60 to 64 years
- Conditions the study is for
- 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
- 393 participants
- Where
- 8 sitesin 8 countries
- Study dates
- Dec 2006to Feb 2008
- 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 60 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of major depressive disorder, recurrent, as defined by Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR) criteria (296.3) and confirmed by the semi-structured Mini International Neuropsychiatric Interview (MINI).
Who cannot join
- Total score of less than 23 on the MADRS.
- HAM-D total score less than 17.
- Duration of the current depressive episode less than 1 month or greater than 2 years.
- Patients with an Mini Mental State Examination score of less than 23.
- Patients with a history or presence of bipolar disorders or psychotic disorders.
- Patients with alcohol/substance dependence or abuse in the past 12 months except nicotine or caffeine dependence.
- Patients who have used the following prior to entry into Acute Phase: antipsychotics within 3 months, fluoxetine within 1 month, monoamine oxidase inhibitors within 4 weeks, other antidepressants, or mood-stabilizer (lithium, anticonvulsants) within 1 week.
- The investigator will evaluate whether there are other reasons why a patient may not participate
Trial locations and contacts
8 sites in 8 countries.
8 sites in 8 countries
United States1 site
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, 08807
About this study
Official title: An Eight-week, Multinational, Multicenter, Randomized, Double-blind, Placebo-controlled Study, With Escitalopram as an Active Control, to Evaluate the Efficacy, Safety and Tolerability of a Saredutant 100 mg Dose Once Daily, in Elderly Patients With Major Depressive Disorder
The purpose of the study is to evaluate the efficacy of saredutant in the treatment of Major Depressive Disorder in elderly patients.To evaluate the tolerability, safety and efficacy on disability and quality of life in patients with major depressive disorder.To evaluate safety and tolerability of 24 weeks of additional treatment in patients completing the initial 8-week treatment period.
- Conditions
- Depressive Disorder
- Being tested
- saredutant (SR48968), placebo, escitalopram
- Keywords
- Depression, Major depressive disorders, Controlled clinical trial
- Medical subject headings
- Depressive Disorder, Depression, Depressive Disorder, Major
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)
placeboDrug
oral administration (capsules)
escitalopramDrug
oral administration (capsules)
| Study group | Role | What they receive |
|---|---|---|
| Saredutant 100 mg | Experimental | Saredudant100 mg once daily for a maximum of 32 weeks Receives: Drug: saredutant (SR48968) |
| Escitalopram 10 mg | Active comparator | Escitalopram 10 mg once daily for a maximum of 32 weeks Receives: Drug: escitalopram |
| Placebo | Placebo comparator | Placebo once daily for one week during screening phase and a maximum of 8 weeks during the acute 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 the 17-item Hamilton Depression Rating Scale (HAM-D) total score.
Measured: Day 56
Secondary outcomes (3)
Change from baseline to Day 56 in the Clinical Global Impression (CGI) Severity of Illness score.
Measured: Day 56
Change from baseline to Day 56 in the HAM-D depressed mood item score
Measured: Day 56
Change from baseline to Day 56 in the Montgomery-Asberg Depression Rating Scale (MADRS) total score
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 posted22 Dec 2006 (estimated)
- Study startDec 2006
- Primary completionFeb 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 393 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00415142
- Sponsor's protocol ID
- EFC5574
- Status last verified
- Apr 2016
- First submitted
- 21 Dec 2006
- 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, Multinational, Multicenter, Randomized, Double-blind, Placebo-controlled Study, With Escitalopram as an Active Control, to Evaluate the Efficacy, Safety and Tolerability of a Saredutant 100 mg Dose Once Daily, in Elderly Patients With Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT00415142
- Acronym / sponsor ID
- EFC5574
- Conditions
- Depressive Disorder
- Keywords
- Depression, Major depressive disorders, Controlled clinical trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 393 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 22 Dec 2006 (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 purpose of the study is to evaluate the efficacy of saredutant in the treatment of Major Depressive Disorder in elderly patients.To evaluate the tolerability, safety and efficacy on disability and quality of life in patients with major depressive disorder.To evaluate safety and tolerability of 24 weeks of additional treatment in patients completing the initial 8-week treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Saredutant 100 mg | Experimental | Drug: saredutant (SR48968)Saredudant100 mg once daily for a maximum of 32 weeks |
| Escitalopram 10 mg | Active comparator | Drug: escitalopramEscitalopram 10 mg once daily for a maximum of 32 weeks |
| Placebo | Placebo comparator | Drug: placeboPlacebo once daily for one week during screening phase and a maximum of 8 weeks during the acute phase |
Who may qualify
- Ages
- 60 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Diagnosis of major depressive disorder, recurrent, as defined by Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR) criteria (296.3) and confirmed by the semi-structured Mini International Neuropsychiatric Interview (MINI).
Key exclusion criteria (8 listed)
- Total score of less than 23 on the MADRS.
- HAM-D total score less than 17.
- Duration of the current depressive episode less than 1 month or greater than 2 years.
- Patients with an Mini Mental State Examination score of less than 23.
- Patients with a history or presence of bipolar disorders or psychotic disorders.
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 | Saredutant 100 mg |
| placebooral administration (capsules) | Drug | Placebo |
| escitalopramoral administration (capsules) | Drug | Escitalopram 10 mg |
Primary outcome
Change from baseline to Day 56 in the 17-item Hamilton Depression Rating Scale (HAM-D) total score.
Time frame: Day 56
3 secondary outcomes
Change from baseline to Day 56 in the Clinical Global Impression (CGI) Severity of Illness score.
Time frame: Day 56
Change from baseline to Day 56 in the HAM-D depressed mood item score
Time frame: Day 56
Change from baseline to Day 56 in the Montgomery-Asberg Depression Rating Scale (MADRS) total score
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.
Clinical Sciences & Operations study director
Sanofi
8 sites in 8 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 Depressive Disorder, run by Sanofi at 8 sites in 8 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 8 sites in United States, Croatia, Czechia, France, Mexico and 3 more countries. 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 the 17-item Hamilton Depression Rating Scale (HAM-D) total score. (time frame: Day 56). 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.