Major Depressive DisorderPhase 3ALBERIONCT00432614
Efficacy and Safety of SR58611A co-Administered With Escitalopram in Adults With Major Depressive Disorder
A Phase 3 study testing SR58611A and escitalopram in people with Major Depressive Disorder, run by Sanofi at 13 sites in 13 countries.
Trial summary
The primary objective of the study is to compare, after 8 weeks, the efficacy of SR58611A vs. placebo in patients with Major Depressive Disorder who are on concomitant treatment with escitalopram. 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?
- SR58611A and escitalopram
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 510 participants
- Where
- 13 sitesin 13 countries
- Study dates
- Jan 2007to 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inpatients or outpatients with Major Depressive Disorder characterized by a recurrent Major Depressive Episode with Montgomery and Asberg Depression Rating Scale (MADRS) total score => 30
Who cannot join
- Patient is at immediate risk for suicidal behavior
- Patient with psychotic features, catatonic features, seasonal pattern or postpartum onset
- Patients with a current depressive episode secondary to a general medical disorder
- Patients with a lifetime history or presence of bipolar disorder, psychotic disorder, panic disorder and antisocial personality disorder
- Patients with severe or unstable concomitant medical conditions
- Pregnant, breastfeeding, or likely to become pregnant during the study
- Treated with escitalopram within 6 months before the study, or who have had an adverse reaction to escitalopram
- The investigator will evaluate whether there are other reasons why a patient may not participate.
Trial locations and contacts
13 sites in 13 countries.
13 sites in 13 countries
About this study
Official title: A Multi-National, Multi-Center, DB, Placebo-Controlled, Parallel Group, Fixed Dose Efficacy & Safety Study of SR58611A 350 mg Twice Daily vs. Placebo in Adults With Major Depressive Disorder on Concomitant Treatment With Escitalopram 10mg/d
The primary objective of the study is to compare, after 8 weeks, the efficacy of SR58611A vs. placebo in patients with Major Depressive Disorder who are on concomitant treatment with escitalopram.
The secondary objective of this study is to document clinical safety and tolerability of SR58611A in association with escitalopram.
- Conditions
- Major Depressive Disorder
- Being tested
- SR58611A, escitalopram, placebo
- Keywords
- Mental Disorder, Mood Disorder, Depressive Disorder
- Medical subject headings
- Depressive Disorder, Major, Mental Disorders, Mood Disorders, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SR58611ADrug
oral administration
escitalopramDrug
oral administration
placeboDrug
oral administration
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | SR58611A 350mg twice daily with escitalopram 10mg once daily Receives: Drug: SR58611A; Drug: escitalopram |
| Group 2 | Active comparator | placebo with escitalopram 10mg once daily Receives: Drug: escitalopram |
| Group 3 | Placebo comparator | placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Hamilton Depression Rating scale (HAM-D) total score
Measured: 8 weeks
Secondary outcomes (1)
Speed of response based on HAM-D and change in Clinical Global Impression (CGI) severity score
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 posted8 Feb 2007 (estimated)
- Study startJan 2007
- 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 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 510 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- ICD CSD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00432614
- Sponsor's protocol ID
- EFC6224
- Other IDs
- EudraCT 2006-004146-16
- Acronym
- ALBERIO
- Status last verified
- Mar 2009
- First submitted
- 7 Feb 2007
- Last updated
- 25 Mar 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-National, Multi-Center, DB, Placebo-Controlled, Parallel Group, Fixed Dose Efficacy & Safety Study of SR58611A 350 mg Twice Daily vs. Placebo in Adults With Major Depressive Disorder on Concomitant Treatment With Escitalopram 10mg/d
- ClinicalTrials.gov ID
- NCT00432614
- Acronym / sponsor ID
- ALBERIO / EFC6224
- Conditions
- Major Depressive Disorder
- Keywords
- Mental Disorder, Mood Disorder, Depressive Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 510 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 8 Feb 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 primary objective of the study is to compare, after 8 weeks, the efficacy of SR58611A vs. placebo in patients with Major Depressive Disorder who are on concomitant treatment with escitalopram.
The secondary objective of this study is to document clinical safety and tolerability of SR58611A in association with escitalopram.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: SR58611A, Drug: escitalopramSR58611A 350mg twice daily with escitalopram 10mg once daily |
| Group 2 | Active comparator | Drug: escitalopramplacebo with escitalopram 10mg once daily |
| Group 3 | Placebo comparator | Drug: placeboplacebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Inpatients or outpatients with Major Depressive Disorder characterized by a recurrent Major Depressive Episode with Montgomery and Asberg Depression Rating Scale (MADRS) total score => 30
Key exclusion criteria (8 listed)
- Patient is at immediate risk for suicidal behavior
- Patient with psychotic features, catatonic features, seasonal pattern or postpartum onset
- Patients with a current depressive episode secondary to a general medical disorder
- Patients with a lifetime history or presence of bipolar disorder, psychotic disorder, panic disorder and antisocial personality disorder
- Patients with severe or unstable concomitant medical conditions
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 |
|---|---|---|
| SR58611Aoral administration | Drug | Group 1 |
| escitalopramoral administration | Drug | Group 1, Group 2 |
| placebooral administration | Drug | Group 3 |
Primary outcome
Change from baseline in Hamilton Depression Rating scale (HAM-D) total score
Time frame: 8 weeks
1 secondary outcome
Speed of response based on HAM-D and change in Clinical Global Impression (CGI) severity score
Time frame: 8 weeks
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 25 Mar 2009.
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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 CSD study director
Sanofi
13 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SR58611A and escitalopram in people with Major Depressive Disorder, run by Sanofi at 13 sites in 13 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 25 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Belgium, Estonia, Finland, France, Germany and 8 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 in Hamilton Depression Rating scale (HAM-D) total score (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 25 Mar 2009.