Efficacy and safety of tianeptine oral administration (25 to 50 mg/day) in elderly patients suffering from Major Depressive Disorder.

Conditions: Major Depressive Disorder
MedDRA version: 17.0Level: PTClassification code 10057840Term: Major depressionSystem Organ Class: 10037175 - Psychiatric disorders
Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

Registration Number: EUCTR2012-005612-26-EE

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

Inclusion Criteria

- 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

Exclusion Criteria

- 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
Main Objective: To demonstrate the antidepressant efficacy of an 8-week tianeptine oral administration in elderly out-patients suffering from Major Depressive Disorder compared to placebo. The assay sensitivity will be evaluated comparing escitalopram to placebo.;Secondary Objective: The secondary objectives are:<br>- to study tianeptine acceptability in this population after 8 weeks of treatment<br>- to study tianeptine effects on patient's social functioning after 8 weeks of treatment<br>- to obtain additional efficacy data in this population after 6 months of treatment<br>- to obtain additional acceptability data in this population after 6 months of treatment;Primary end point(s): HAM-D 17 total score;Timepoint(s) of evaluation of this end point: All visit till W008

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Depression symptoms:<br>- Clinical Global Impression (CGI) Item 1 (severity of illness), 2 (global improvement) and 3 (efficacy index)<br>- Hospital Anxiety and Depression scale (HADS)<br>Social functioning:<br>- Sheehan Disability Scale (SDS) score<br>Safety criteria;Timepoint(s) of evaluation of this end point: All over the study