Major Depressive DisordersPhase 3NCT00825019
Efficacy and Safety of One Single Dose of SR58611 Compared to Placebo and Paroxetine
A Phase 3 study testing amibegron (SR58611A) and paroxetine in people with Major Depressive Disorders, run by Sanofi at 1 site in United States.
Trial summary
Primary objective is to demonstrate the antidepressant efficacy on the Hamilton depression rating scale (HAM-D) of amibegron (SR58611) 700 mg/day compared to placebo in the treatment of patients with a recurrent major depressive episode (MDD). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorders
- What is being tested?
- amibegron (SR58611A) and paroxetine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 306 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2003to Dec 2004
- 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
- patients suffering from a recurrent major depressive episode of at least moderate intensity (DSM-IV)
- patients have been hospitalized for the treatment of a previous episode, or a previous episode required antidepressant treatment(s)at the recommended dose level for at least 2 months.
- the duration of the current episode is of at least six weeks unless the severity of symptoms justifies shorter duration.
Who cannot join
None listed.
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: A Double-Blind, Multicenter Study Evaluating the Efficacy and Safety of One Fixed Dose of SR58611A (700 mg/Day) Versus Placebo and Paroxetine (20 mg/Day) in Patients With a Recurrent Major Depressive Episode.
Primary objective is to demonstrate the antidepressant efficacy on the Hamilton depression rating scale (HAM-D) of amibegron (SR58611) 700 mg/day compared to placebo in the treatment of patients with a recurrent major depressive episode (MDD).
Secondary objective is to assess the safety profile of amibegron 700 mg/d in comparison to placebo and to assess plasma concentrations of the active metabolite.
- Conditions
- Major Depressive Disorders
- Being tested
- amibegron (SR58611A), placebo, paroxetine
- Keywords
- Depression
- 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
oral administration of 2x 700 mg/day in 12h intervals
placeboDrug
oral administration in 12h intervals
paroxetineDrug
oral administration of 20 mg/day
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: amibegron (SR58611A) |
| 2 | Placebo comparator | Not described Receives: Drug: placebo |
| 3 | Active comparator | paroxetine Receives: Drug: paroxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline of the total score of the HAM-D 17 items
Measured: 6 weeks
Secondary outcomes (7)
HAM-D subscores, HAMD responders and remitters, HAM-A total score and subscores
Measured: 6 weeks
Montgomery-Asberg Depression Rating Scale (MADRS) total score
Measured: 6 weeks
clinical global impression (CGI) severity and improvement scores
Measured: 6 weeks
patient global impression (PGI) improvement score
Measured: 6 weeks
social and occupational functioning assessment scale (SOFAS) score
Measured: 6 weeks
AEs, Arizona Sexual Experience Scale (ASEX),
Measured: 6 weeks
laboratory parameters, physical examination findings, ECG parameters, change of vital signs, body weight
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2009 (estimated)
- Study startSep 2003
- Primary completionOct 2004
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisordersStudies 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
- 306 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
- NCT00825019
- Sponsor's protocol ID
- EFC5379
- Status last verified
- Mar 2009
- First submitted
- 16 Jan 2009
- 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 Double-Blind, Multicenter Study Evaluating the Efficacy and Safety of One Fixed Dose of SR58611A (700 mg/Day) Versus Placebo and Paroxetine (20 mg/Day) in Patients With a Recurrent Major Depressive Episode.
- ClinicalTrials.gov ID
- NCT00825019
- Acronym / sponsor ID
- EFC5379
- Conditions
- Major Depressive Disorders
- Keywords
- Depression
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 306 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Sep 2003
- Primary completion
- Oct 2004 (actual)
- Study completion
- Dec 2004 (actual)
- First posted
- 19 Jan 2009 (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.
Primary objective is to demonstrate the antidepressant efficacy on the Hamilton depression rating scale (HAM-D) of amibegron (SR58611) 700 mg/day compared to placebo in the treatment of patients with a recurrent major depressive episode (MDD).
Secondary objective is to assess the safety profile of amibegron 700 mg/d in comparison to placebo and to assess plasma concentrations of the active metabolite.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: amibegron (SR58611A) |
| 2 | Placebo comparator | Drug: placebo |
| 3 | Active comparator | Drug: paroxetineparoxetine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients suffering from a recurrent major depressive episode of at least moderate intensity (DSM-IV)
- patients have been hospitalized for the treatment of a previous episode, or a previous episode required antidepressant treatment(s)at the recommended dose level for at least 2 months.
- the duration of the current episode is of at least six weeks unless the severity of symptoms justifies shorter duration.
Key exclusion criteria (0 listed)
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)oral administration of 2x 700 mg/day in 12h intervals | Drug | 1 |
| placebooral administration in 12h intervals | Drug | 2 |
| paroxetineoral administration of 20 mg/day | Drug | 3 |
Primary outcome
change from baseline of the total score of the HAM-D 17 items
Time frame: 6 weeks
7 secondary outcomes
HAM-D subscores, HAMD responders and remitters, HAM-A total score and subscores
Time frame: 6 weeks
Montgomery-Asberg Depression Rating Scale (MADRS) total score
Time frame: 6 weeks
clinical global impression (CGI) severity and improvement scores
Time frame: 6 weeks
patient global impression (PGI) improvement score
Time frame: 6 weeks
social and occupational functioning assessment scale (SOFAS) score
Time frame: 6 weeks
AEs, Arizona Sexual Experience Scale (ASEX),
Time frame: 6 weeks
laboratory parameters, physical examination findings, ECG parameters, change of vital signs, body weight
Time frame: 6 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
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) and paroxetine in people with Major Depressive Disorders, 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 0 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. 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 of the total score of the HAM-D 17 items (time frame: 6 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.