[Major depressive episodes in patients over 70 years of age. Evaluation of the efficiency and acceptability of tianeptine and mianserin]

Abstract

Objectives: The aim of this multicenter study was to compare the efficacy, acceptability and impact on quality of life of tianeptine (T) and mianserine (M) in patients over 70 years of age with major depression.

Methods: Fulfilment of the DSM IIIR criteria for major depression with a total Montgomery and Asberg depression rating scale (MADRS) of at least 25 and a Hamilton anxiety rating scale (HARS) of at least 18 were required for inclusion. The 315 men and women enrolled in the study were given, by double blind assignment, either T: 37.5 mg/day, T: 25 mg/day or M: 30 mg/day. Treatment duration was 6 months in all three groups and follow-up continued for 3 months after withdrawal of tianeptine or mianserine. The main efficacy criterion was the MADRS score evaluated at each of 6 visits at day 15 (D15) and month 1 (M1), M2, M4, M4.5 and M6. The HARS score was another efficacy criterion. Overall assessment of efficacy and acceptability was done at each visit by the patient and the investigator. Both the patient and the physician estimated global effectiveness on a quality of life scale at M1, M3, M6 and M9.

Results: In the intention-to-treat population (n = 299), the antidepressant efficacy of tianeptine and mianserine was not significantly different, whether assessed as effect on anxiety or on quality of life. Scores however tended to be better in the T: 37.5 mg group. Acceptability was good as shown by the low number of adverse events in all 3 groups, but at D15, the incidence of impaired vigilance or equilibrium was significantly lower in the T: 25 mg group than in the M: 30 mg group, emphasizing the advantage of tianeptine in decreasing the risk of falling. Physician-assessed tolerance and acceptability was significantly different at M3 (p = 0.014) and at M6 (p = 0.028) in favor of T: 37.5 mg, indicating that though increasing dosage does not improve efficacy, there is no risk of poorer acceptability.

Conclusion: These findings reconfirm the antidepressive efficacy, acceptability and safety of tianeptine. They also confirm the anxiolytic aspect associated with the antidepressive effect of tianeptine without any sedative effect. Tianeptine is particularly well indicated in the treatment of depression in elderly or very elderly subjects.