Major Depressive DisorderPhase 3NCT00385307
Efficacy and Safety of SR58611A in Patients With Major Depressive Disorder (SIRIUS)
A Phase 3 study testing amibegron (SR58611A) in people with Major Depressive Disorder, run by Sanofi at 1 site in United States.
Trial summary
To evaluate the efficacy of two fixed doses of SR58611A (175 mg q12 and 350 mg q12) compared to placebo in patients with Major Depressive Disorder (MDD) using paroxetine (20 mg qd) as positive control. In addition, the tolerability and safety of SR58611A in patients with MDD will be evaluated. 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?
- amibegron (SR58611A)
- How many people
- 680 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Nov 2007
- 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
- Patient with Major Depressive Disorder diagnosed according to Diagnostic and Statistical Manual of Mental Disorders DSM-IV-TR
- Patient meets criteria for a recurrent Major Depressive Episode (MDE)
- Patient meets severity assessments of depression specified by the study
Who cannot join
- Patient is at immediate risk for suicidal behavior
- Patient is with a unstable medical condition
- Patient with psychotic features, catatonic features, seasonal pattern or postpartum onset
- Patient has taken concomitant treatment that may interfere with valid collection or interpretation of study data
- Patient has been treated with non-pharmacologic therapy intended to treat depression in the past 6 months
- Patient has been treated with paroxetine (Paxil) within the previous 6 months
- Patient is pregnant or breastfeeding, or likely to become pregnant during the course of the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, 08807
About this study
Official title: An Eight-Week, Double-Blind, Placebo-Controlled, Multicenter Study With Paroxetine (10 mg qd) as Positive Control, Evaluating the Efficacy, Safety, Tolerability of Two Fixed Doses of SR58611A (175 mg q12/ 350 mg q12) in Outpatients With MDD
To evaluate the efficacy of two fixed doses of SR58611A (175 mg q12 and 350 mg q12) compared to placebo in patients with Major Depressive Disorder (MDD) using paroxetine (20 mg qd) as positive control. In addition, the tolerability and safety of SR58611A in patients with MDD will be evaluated.
- Conditions
- Major Depressive Disorder
- Being tested
- amibegron (SR58611A)
- Keywords
- Depression, Clinical Trials, Major Depressive Disorder
- 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.
amibegron (SR58611A)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in total score of a depression rating scale at 8 weeks
Secondary outcomes (1)
Safety assessments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2006 (estimated)
- Study startSep 2006
- Primary completionNov 2007
- Study completionNov 2007
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
- 680 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
- NCT00385307
- Sponsor's protocol ID
- EFC6607
- Status last verified
- Mar 2009
- First submitted
- 6 Oct 2006
- 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
- An Eight-Week, Double-Blind, Placebo-Controlled, Multicenter Study With Paroxetine (10 mg qd) as Positive Control, Evaluating the Efficacy, Safety, Tolerability of Two Fixed Doses of SR58611A (175 mg q12/ 350 mg q12) in Outpatients With MDD
- ClinicalTrials.gov ID
- NCT00385307
- Acronym / sponsor ID
- EFC6607
- Conditions
- Major Depressive Disorder
- Keywords
- Depression, Clinical Trials, Major Depressive Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 680 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 9 Oct 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.
To evaluate the efficacy of two fixed doses of SR58611A (175 mg q12 and 350 mg q12) compared to placebo in patients with Major Depressive Disorder (MDD) using paroxetine (20 mg qd) as positive control. In addition, the tolerability and safety of SR58611A in patients with MDD will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient with Major Depressive Disorder diagnosed according to Diagnostic and Statistical Manual of Mental Disorders DSM-IV-TR
- Patient meets criteria for a recurrent Major Depressive Episode (MDE)
- Patient meets severity assessments of depression specified by the study
Key exclusion criteria (7 listed)
- Patient is at immediate risk for suicidal behavior
- Patient is with a unstable medical condition
- Patient with psychotic features, catatonic features, seasonal pattern or postpartum onset
- Patient has taken concomitant treatment that may interfere with valid collection or interpretation of study data
- Patient has been treated with non-pharmacologic therapy intended to treat depression in the past 6 months
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 |
|---|---|---|
| amibegron (SR58611A) | Drug | – |
Primary outcome
Change from baseline in total score of a depression rating scale at 8 weeks
1 secondary outcome
Safety assessments
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.
Related trials for Major Depressive Disorder
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Not yet recruiting
Acute Intermittent Hypoxia Therapy for Depression
Major Depressive Disorder (MDD)
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing amibegron (SR58611A) in people with Major Depressive Disorder, run by Sanofi at 1 site in United States.
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 3 inclusion and 7 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 1 site in United States. 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?
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 total score of a depression rating scale at 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.