An Eight-week Study Evaluating the Efficacy of a 100mg Dose of Saredutant Once Daily, in Elderly Patients With Major Depressive Disorder

Study Overview
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Brief Summary
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The purpose of the study is to evaluate the efficacy of saredutant in the treatment of Major Depressive Disorder in elderly patients.To evaluate the tolerability, safety and efficacy on disability and quality of life in patients with major depressive disorder.To evaluate safety and tolerability of 24 weeks of additional treatment in patients completing the initial 8-week treatment period.

Official Title
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An Eight-week, Multinational, Multicenter, Randomized, Double-blind, Placebo-controlled Study, With Escitalopram as an Active Control, to Evaluate the Efficacy, Safety and Tolerability of a Saredutant 100 mg Dose Once Daily, in Elderly Patients With Major Depressive Disorder

Conditions
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Depressive Disorder

Intervention / Treatment
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* Drug: saredutant (SR48968)
* Drug: placebo
* Drug: escitalopram


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of major depressive disorder, recurrent, as defined by 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). Exclusion Criteria: Total score of less than 23 on the MADRS. 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

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Saredutant 100 mg<br>Saredudant100 mg once daily for a maximum of 32 weeks | Drug: saredutant (SR48968)<br>* oral administration (capsules)<br>|
| Active Comparator: Escitalopram 10 mg<br>Escitalopram 10 mg once daily for a maximum of 32 weeks | Drug: escitalopram<br>* oral administration (capsules)<br>|
| Placebo Comparator: Placebo<br>Placebo once daily for one week during screening phase and a maximum of 8 weeks during the acute phase | Drug: placebo<br>* oral administration (capsules)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to Day 56 in the 17-item Hamilton Depression Rating Scale (HAM-D) total score. |  | Day 56 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to Day 56 in the Clinical Global Impression (CGI) Severity of Illness score. |  | Day 56 | 
| Change from baseline to Day 56 in the HAM-D depressed mood item score |  | Day 56 | 
| Change from baseline to Day 56 in the Montgomery-Asberg Depression Rating Scale (MADRS) total score |  | Day 56 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, Major depressive disorders, Controlled clinical trial