Efficacy and Safety of SR58611A co-Administered With Escitalopram in Adults With Major Depressive Disorder
NCT ID: NCT00432614
Last Updated: 2009-03-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
510 participants
INTERVENTIONAL
2007-01-31
2008-02-29
Brief Summary
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The secondary objective of this study is to document clinical safety and tolerability of SR58611A in association with escitalopram.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Group 1
SR58611A 350mg twice daily with escitalopram 10mg once daily
SR58611A
oral administration
escitalopram
oral administration
Group 2
placebo with escitalopram 10mg once daily
escitalopram
oral administration
Group 3
placebo
placebo
oral administration
Interventions
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SR58611A
oral administration
escitalopram
oral administration
placebo
oral administration
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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sanofi-aventis
Principal Investigators
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ICD CSD
Role: STUDY_DIRECTOR
Sanofi
Locations
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Sanofi-Aventis Administrative Office
Diegem, , Belgium
Sanofi-Aventis Administrative Office
Tatari, , Estonia
Sanofi-Aventis Administrative Office
Helsinki, , Finland
Sanofi-Aventis Administrative Office
Paris, , France
Sanofi-Aventis Administrative Office
Berlin, , Germany
Sanofi-Aventis Administrative Office
Athens, , Greece
Sanofi-Aventis Administrative Office
Mumbai, , India
Sanofi-Aventis Administrative Office
Kuala Lumpur, , Malaysia
Sanofi-Aventis Administrative Office
Casablanca, , Morocco
Sanofi-Aventis Administrative Office
Seoul, , South Korea
Sanofi-Aventis Administrative Office
Taipei, , Taiwan
Sanofi-Aventis Administrative Office
Mégrine, , Tunisia
Sanofi-Aventis Administrative Office
Istanbul, , Turkey (Türkiye)
Countries
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Other Identifiers
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EudraCT 2006-004146-16
Identifier Type: -
Identifier Source: secondary_id
EFC6224
Identifier Type: -
Identifier Source: org_study_id
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