Clinical trial NCT00415142: An Eight-week Study Evaluating the Efficacy of a 100mg Dose of Saredutant Once Daily, in Elderly Patients With Major Depressive Disorder
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Depressive Disorder
Keywords: Depression
Major depressive disorders
Controlled clinical trial
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-12-22
Enrollment: 393
Sex: ALL
Minimum age (years): 60
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline to Day 56 in the 17-item Hamilton Depression Rating Scale (HAM-D) total score.
timeFrame: Day 56
Secondary outcomes:
measure: Change from baseline to Day 56 in the Clinical Global Impression (CGI) Severity of Illness score.
timeFrame: Day 56
measure: Change from baseline to Day 56 in the HAM-D depressed mood item score
timeFrame: Day 56
measure: Change from baseline to Day 56 in the Montgomery-Asberg Depression Rating Scale (MADRS) total score
timeFrame: Day 56
Other outcomes:
Locations:
city: Bridgewater
country: United States
facility: Sanofi-Aventis Administrative Office
state: New Jersey
city: Zagreb
country: Croatia
facility: Sanofi-Aventis Administrative Office
city: Praha
country: Czech Republic
facility: Sanofi-Aventis Administrative Office
city: Paris
country: France
facility: Sanofi-Aventis Administrative Office
city: Mexico
country: Mexico
facility: Sanofi-Aventis Administrative Office
city: Moscow
country: Russian Federation
facility: Sanofi-Aventis Administrative Office
city: Bromma
country: Sweden
facility: Sanofi-Aventis Administrative Office
city: Istanbul
country: Turkey
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: