Major Depressive Disorder MedDRA version: 17.0 Level: PT Classification code 10057840 Term: Major depression System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Trade Name: Stablon
Product Name: S01574
Product Code: S01574
Pharmaceutical Form: Capsule
INN or Proposed INN: TIANEPTINE
CAS Number: 66981-73-5
Concentration unit: mg milligram(s)
Concentration type
Sponsors
Institut de Recherches Internationales Servier
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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: - to study tianeptine acceptability in this population after 8 weeks of treatment - to study tianeptine effects on patient's social functioning after 8 weeks of treatment - to obtain additional efficacy data in this population after 6 months of treatment - 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): Depression symptoms: - Clinical Global Impression (CGI) Item 1 (severity of illness), 2 (global improvement) and 3 (efficacy index) - Hospital Anxiety and Depression scale (HADS) Social functioning: - Sheehan Disability Scale (SDS) score Safety criteria;Timepoint(s) of evaluation of this end point: All over the study | — |
Countries
Bulgaria, Estonia, Finland, France, Korea, Republic of, Malaysia, Mexico, Romania, Slovakia
Contacts
Public ContactClinical Studies Department
Institut de Recherches Internationales Servier
Outcome results
None listed