Efficacy and safety of tianeptine oral administration (25 to 50 mg/day) in elderly patients suffering from Major Depressive Disorder.A 8-week, randomized, double-blind, flexible-dose, parallel groups, placebo-controlled, international, multicentre study with escitalopram as active control, followed by an optional double-blind extension treatment period of 16 weeks.
- Conditions
- Major Depressive DisorderMedDRA version: 17.0Level: PTClassification code 10057840Term: Major depressionSystem Organ Class: 10037175 - Psychiatric disordersTherapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2012-005612-26-SK
- Lead Sponsor
- Institut de Recherches Internationales Servier
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 300
- All patients selected will be aged 65 and over, male or female, out-patients.
- Fulfilling DSM-IV-TR criteria for Major Depressive Episode confirmed by the M.I.N.I. structured interview
- Fulfilling DSM-IV-TR diagnostic criteria for Recurrent Major Depressive Disease
- HAM-D 17 total score = 22
- CGI item 1 (severity of illness) score = 4
- HADS depression subscore =11
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 300
- All types of depression other than MDD Recurrent according to DSM-IV-TR criteria
- Resistant depression (for the current episode): patients who have not responded to 2 antidepressant drugs of different classes used for at least 4 weeks duration at an appropriate dose
- Patients not able to read or to complete self-rating questionnaires
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method