An Eight-week Study Evaluating the Efficacy of a 100mg Dose of Saredutant Once Daily, in Elderly Patients With Major Depressive Disorder
NCT ID: NCT00415142
Last Updated: 2016-05-24
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
393 participants
INTERVENTIONAL
2006-12-31
2008-02-29
Brief Summary
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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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Saredutant 100 mg
Saredudant100 mg once daily for a maximum of 32 weeks
saredutant (SR48968)
oral administration (capsules)
Escitalopram 10 mg
Escitalopram 10 mg once daily for a maximum of 32 weeks
escitalopram
oral administration (capsules)
Placebo
Placebo once daily for one week during screening phase and a maximum of 8 weeks during the acute phase
placebo
oral administration (capsules)
Interventions
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saredutant (SR48968)
oral administration (capsules)
placebo
oral administration (capsules)
escitalopram
oral administration (capsules)
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* HAM-D total score less than 17.
* Duration of the current depressive episode less than 1 month or greater than 2 years.
* Patients with an Mini Mental State Examination score of less than 23.
* Patients with a history or presence of bipolar disorders or psychotic disorders.
* Patients with alcohol/substance dependence or abuse in the past 12 months except nicotine or caffeine dependence.
* Patients who have used the following prior to entry into Acute Phase: antipsychotics within 3 months, fluoxetine within 1 month, monoamine oxidase inhibitors within 4 weeks, other antidepressants, or mood-stabilizer (lithium, anticonvulsants) within 1 week.
The investigator will evaluate whether there are other reasons why a patient may not participate
60 Years
64 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States
Sanofi-Aventis Administrative Office
Zagreb, , Croatia
Sanofi-Aventis Administrative Office
Prague, , Czechia
Sanofi-Aventis Administrative Office
Paris, , France
Sanofi-Aventis Administrative Office
México, , Mexico
Sanofi-Aventis Administrative Office
Moscow, , Russia
Sanofi-Aventis Administrative Office
Bromma, , Sweden
Sanofi-Aventis Administrative Office
Istanbul, , Turkey (Türkiye)
Countries
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Other Identifiers
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EFC5574
Identifier Type: -
Identifier Source: org_study_id
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