Major DepressionPhase 2AGATENCT01034995
A Trial Evaluating the Efficacy and Tolerability of SSR125543 in Outpatients With Major Depressive Disorder
A Phase 2 study testing SSR125543 and escitalopram in people with Major Depression, run by Sanofi at 73 sites in 12 countries.
Trial summary
Primary Objective: To evaluate the efficacy of three fixed doses of SSR125543 (20 mg daily, 50 mg daily, and 100 mg daily) compared to placebo in outpatients with major depressive disorder, as assessed by the change from baseline (Day -1) to Day 56 in the 17-item Hamilton Depression Rating Scale (HAM-D) total score. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Major Depression
- What is being tested?
- SSR125543 and escitalopram
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 580 participants
- Where
- 73 sitesin 12 countries
- Study dates
- Feb 2010to Mar 2011
- Phase
- Phase 2
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with a diagnosis of major depressive disorder, as defined by the 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
- Inpatient hospitalization at screening
- Symptoms of depression present for <30 days or >2 years
- Significant suicide risk
- Mild depression as measured by standard clinical research scales
- History of failure to respond to antidepressant treatment
- Other psychiatric conditions that could obscure the results of the study
- For women of child-bearing potential, the unwillingness to use highly effective means of birth control
- 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
73 sites in 12 countries.
73 sites in 12 countries
Russia11 sites
Sanofi-Aventis Investigational Site Number 643006
Moscow, 117152
Sanofi-Aventis Investigational Site Number 643005
Nizhny Novgorod, 603155
Sanofi-Aventis Investigational Site Number 643008
Rostov-on-Don, 344010
Sanofi-Aventis Investigational Site Number 643001
Saint Petersburg, 190005
Sanofi-Aventis Investigational Site Number 643009
Saint Petersburg, 190121
Sanofi-Aventis Investigational Site Number 643010
Saint Petersburg, 190121
Sanofi-Aventis Investigational Site Number 643011
Saint Petersburg, 191119
Sanofi-Aventis Investigational Site Number 643003
Saint Petersburg, 192019
Sanofi-Aventis Investigational Site Number 643002
Saint Petersburg, 194044
Sanofi-Aventis Investigational Site Number 643004
Samara, 443016
Sanofi-Aventis Investigational Site Number 643007
Smolensk, 214019
Canada9 sites
Sanofi-Aventis Investigational Site Number 124011
Burlington, L7R 4E2
Sanofi-Aventis Investigational Site Number 124012
Chatham, N7M 1B7
Sanofi-Aventis Investigational Site Number 124004
Edmonton, T6L 5X8
Sanofi-Aventis Investigational Site Number 124003
Gatineau, J9A 1K7
Sanofi-Aventis Investigational Site Number 124001
Kelowna, V1Y 1Z9
Sanofi-Aventis Investigational Site Number 124006
Mississauga, L5M 4N4
Sanofi-Aventis Investigational Site Number 124008
Penticton, V2A 4M4
Sanofi-Aventis Investigational Site Number 124007
Sherbrooke, J1V 4J7
Sanofi-Aventis Investigational Site Number 124009
Toronto, M3H 5S4
Chile8 sites
Sanofi-Aventis Investigational Site Number 152001
Santiago, 750-0710
Sanofi-Aventis Investigational Site Number 152002
Santiago, 751-0041
Sanofi-Aventis Investigational Site Number 152003
Santiago, 756-0356
Sanofi-Aventis Investigational Site Number 152005
Santiago, 8053095
Sanofi-Aventis Investigational Site Number 152006
Santiago, 890-0085
Sanofi-Aventis Investigational Site Number 152004
Santiago
Sanofi-Aventis Investigational Site Number 152007
Valparaíso, 236-0002
Sanofi-Aventis Investigational Site Number 152008
Viña del Mar
France8 sites
Sanofi-Aventis Investigational Site Number 250008
Arcachon, 33120
Sanofi-Aventis Investigational Site Number 250007
Dole, 39100
Sanofi-Aventis Investigational Site Number 250006
Élancourt, 78990
Sanofi-Aventis Investigational Site Number 250001
Grenoble, 38043
Sanofi-Aventis Investigational Site Number 250003
Montpellier, 34295
Sanofi-Aventis Investigational Site Number 250005
Nîmes, 30029
Sanofi-Aventis Investigational Site Number 250004
Orvault, 44700
Sanofi-Aventis Investigational Site Number 250002
Toulouse, 31000
Germany8 sites
Sanofi-Aventis Investigational Site Number 276008
Achim, 28832
Sanofi-Aventis Investigational Site Number 276002
Berlin, 10629
Sanofi-Aventis Investigational Site Number 276004
Dresden, 01307
Sanofi-Aventis Investigational Site Number 276005
Leipzig, 04107
Sanofi-Aventis Investigational Site Number 276006
Mannheim, 68159
Sanofi-Aventis Investigational Site Number 276007
München, 80333
Sanofi-Aventis Investigational Site Number 276001
Schwerin, 19053
Sanofi-Aventis Investigational Site Number 276003
Würzburg, 97070
South Africa6 sites
Sanofi-Aventis Investigational Site Number 710005
Cape Town, 7530
Sanofi-Aventis Investigational Site Number 710001
Cape Town, 7646
Sanofi-Aventis Investigational Site Number 710006
Centurion, 0157
Sanofi-Aventis Investigational Site Number 710002
Durban, 3629
Sanofi-Aventis Investigational Site Number 710003
Pretoria, 0181
Sanofi-Aventis Investigational Site Number 710004
Somerset West, 7130
Finland5 sites
Sanofi-Aventis Investigational Site Number 246001
Helsinki, 00260
Sanofi-Aventis Investigational Site Number 246003
Helsinki, 00530
Sanofi-Aventis Investigational Site Number 246005
Jarvenpaa, 04400
Sanofi-Aventis Investigational Site Number 246002
Tampere, 33200
Sanofi-Aventis Investigational Site Number 246004
Turku, 20100
Slovakia5 sites
Sanofi-Aventis Investigational Site Number 703102
Bratislava, 81107
Sanofi-Aventis Investigational Site Number 703101
Bratislava, 82606
Sanofi-Aventis Investigational Site Number 703104
Michalovce, 07101
Sanofi-Aventis Investigational Site Number 703105
Rimavská Sobota, 979 12
Sanofi-Aventis Investigational Site Number 703103
Rožňava, 04801
Sweden5 sites
Sanofi-Aventis Investigational Site Number 752004
Linköping, 582 16
Sanofi-Aventis Investigational Site Number 752002
Lund, 223 61
Sanofi-Aventis Investigational Site Number 752003
Malmö, 211 52
Sanofi-Aventis Investigational Site Number 752005
Stockholm, 112 34
Sanofi-Aventis Investigational Site Number 752001
Uppsala, 753 10
Estonia4 sites
Sanofi-Aventis Investigational Site Number 233001
Tallinn, 10613
Sanofi-Aventis Investigational Site Number 233002
Tallinn, 11911
Sanofi-Aventis Investigational Site Number 233004
Tallinn, 13419
Sanofi-Aventis Investigational Site Number 233003
Tartu, 50406
Belgium3 sites
Sanofi-Aventis Investigational Site Number 056002
Asse, 1730
Sanofi-Aventis Investigational Site Number 056003
Brussels, 1180
Sanofi-Aventis Investigational Site Number 056001
Liège, 4000
Netherlands1 site
Sanofi-Aventis Investigational Site Number 528001
The Hague, 2512 VA
About this study
Official title: An Eight-week, Multinational, Multicenter, Double-blind, Active- and Placebo-controlled Clinical Trial Evaluating the Efficacy and Tolerability of Three Fixed Doses of SSR125543 (20 mg Daily, 50 mg Daily and 100 mg Daily) in Outpatients With Major Depressive Disorder
Primary Objective:
- To evaluate the efficacy of three fixed doses of SSR125543 (20 mg daily, 50 mg daily, and 100 mg daily) compared to placebo in outpatients with major depressive disorder, as assessed by the change from baseline (Day -1) to Day 56 in the 17-item Hamilton Depression Rating Scale (HAM-D) total score.
Secondary Objectives:
- To evaluate the tolerability and safety of SSR125543 in outpatients with major depressive disorder
- To evaluate plasma concentrations of SSR125543
Read the detailed description
This duration of this trial is 11 weeks.
- Conditions
- Major Depression
- Being tested
- SSR125543, escitalopram, placebo
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SSR125543Drug
Pharmaceutical form: capsule
Route of administration: oral
escitalopramDrug
Pharmaceutical form: encapsulated tablets
Route of administration: oral
placeboDrug
Pharmaceutical form: capsule
Route of administration: oral
| Study group | Role | What they receive |
|---|---|---|
| SSR125543 20 mg | Experimental | 1 capsule of SSR125543 20 mg + 1 capsule of placebo Receives: Drug: SSR125543 |
| SSR125543 50 mg | Experimental | 1 capsule of SSR125543 50 mg + 1 capsule of placebo Receives: Drug: SSR125543 |
| SSR125543 100 mg | Experimental | 2 capsules of SSR125543 50 mg Receives: Drug: SSR125543 |
| escitalopram 10 mg | Active comparator | 1 capsule of escitalopram 10 mg + 1 capsule of placebo Receives: Drug: escitalopram |
| placebo | Placebo comparator | 2 capsules of placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline (Day -1) to Day 56 in the 17-item HAM-D total score
Measured: 8 weeks
Secondary outcomes (5)
Change from baseline in HAM-D depressed mood item
Measured: 8 weeks
Change from baseline in HAM-D responders (50% improvement)
Measured: 8 weeks
Changes from baseline in the HAM-D core and factor scores
Measured: 8 weeks
Changes from baseline in the Montgomery-Asberg depression rating scale (MADRS) total score
Measured: 8 weeks
Changes from baseline in the Clinical Global Impression (CGI) Severity of Illness 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 posted18 Dec 2009 (estimated)
- Study startFeb 2010
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major DepressionStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 580 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01034995
- Sponsor's protocol ID
- DFI5687
- Other IDs
- 2009-010339-42, 2009
- Acronym
- AGATE
- Status last verified
- Apr 2011
- First submitted
- 17 Dec 2009
- Last updated
- 14 Apr 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Eight-week, Multinational, Multicenter, Double-blind, Active- and Placebo-controlled Clinical Trial Evaluating the Efficacy and Tolerability of Three Fixed Doses of SSR125543 (20 mg Daily, 50 mg Daily and 100 mg Daily) in Outpatients With Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT01034995
- Acronym / sponsor ID
- AGATE / DFI5687
- Conditions
- Major Depression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 580 participants (estimated)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 18 Dec 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:
- To evaluate the efficacy of three fixed doses of SSR125543 (20 mg daily, 50 mg daily, and 100 mg daily) compared to placebo in outpatients with major depressive disorder, as assessed by the change from baseline (Day -1) to Day 56 in the 17-item Hamilton Depression Rating Scale (HAM-D) total score.
Secondary Objectives:
- To evaluate the tolerability and safety of SSR125543 in outpatients with major depressive disorder
- To evaluate plasma concentrations of SSR125543
Detailed description
This duration of this trial is 11 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| SSR125543 20 mg | Experimental | Drug: SSR1255431 capsule of SSR125543 20 mg + 1 capsule of placebo |
| SSR125543 50 mg | Experimental | Drug: SSR1255431 capsule of SSR125543 50 mg + 1 capsule of placebo |
| SSR125543 100 mg | Experimental | Drug: SSR1255432 capsules of SSR125543 50 mg |
| escitalopram 10 mg | Active comparator | Drug: escitalopram1 capsule of escitalopram 10 mg + 1 capsule of placebo |
| placebo | Placebo comparator | Drug: placebo2 capsules of placebo |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients with a diagnosis of major depressive disorder, as defined by the 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)
- Inpatient hospitalization at screening
- Symptoms of depression present for <30 days or >2 years
- Significant suicide risk
- Mild depression as measured by standard clinical research scales
- History of failure to respond to antidepressant treatment
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 |
|---|---|---|
| SSR125543Pharmaceutical form: capsule Route of administration: oral | Drug | SSR125543 100 mg, SSR125543 20 mg, SSR125543 50 mg |
| escitalopramPharmaceutical form: encapsulated tablets Route of administration: oral | Drug | escitalopram 10 mg |
| placeboPharmaceutical form: capsule Route of administration: oral | Drug | placebo |
Primary outcome
Change from baseline (Day -1) to Day 56 in the 17-item HAM-D total score
Time frame: 8 weeks
5 secondary outcomes
Change from baseline in HAM-D depressed mood item
Time frame: 8 weeks
Change from baseline in HAM-D responders (50% improvement)
Time frame: 8 weeks
Changes from baseline in the HAM-D core and factor scores
Time frame: 8 weeks
Changes from baseline in the Montgomery-Asberg depression rating scale (MADRS) total score
Time frame: 8 weeks
Changes from baseline in the Clinical Global Impression (CGI) Severity of Illness 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 14 Apr 2011.
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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
73 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SSR125543 and escitalopram in people with Major Depression, run by Sanofi at 73 sites in 12 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 14 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 73 sites in Russia, Canada, Chile, France, Germany and 7 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 (Day -1) to Day 56 in the 17-item 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 14 Apr 2011.