Depressive Disorder
Conditions
Keywords
Depression, Major depressive disorders, Controlled clinical trial
Brief summary
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.
Interventions
oral administration (capsules)
DRUGplacebo
oral administration (capsules)
DRUGescitalopram
oral administration (capsules)
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
60 Years to 64 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline to Day 56 in the 17-item Hamilton Depression Rating Scale (HAM-D) total score. | Day 56 |
Secondary
| Measure | 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 |
Countries
Croatia, Czechia, France, Mexico, Russia, Sweden, Turkey (Türkiye), United States
Outcome results
None listed