OBJECTIVES: The aim of this study was to assess the efficacy of tianeptine vs
placebo in the long-term treatment of unipolar major recurrent
depression.
METHOD: 286 patients who met DSM-III-R criteria for
major depression with a Hamilton Depression Rating Scale (HDRS-21 items) score
> or = 17, and with a history of at least one previous episode within the
last 5 years, were treated in an open trial with tianeptine for 6 weeks. 185
patients who responded to treatment at day 42 (intent-to-treat) were randomly
assigned to tianeptine 37.5 mg/day (n = 111), or placebo (n = 74). Among these
patients 173 were strict responders to tianeptine (per-protocol-population),
as defined in the present study by a 50% reduction in the HDRS score, a global
score lower than 15 and confirmation by clinical evaluation. Both groups were
comparable except for the severity of the depressive episode (significantly
more severe in the tianeptine group (33%) than in the placebo group (18%)) (p
= 0.018). Relapses and recurrences were defined by a HDRS score > or = 15,
and/or a CGI score > or = 4, the recurrences being confirmed by the
clinician. Patients were subsequently evaluated at day 63, and the 3rd, 6th,
9th, 12th, 15th and 18th month.
RESULTS: Special attention was given to the number of
relapses and recurrences, and to the delay of onset (Kaplan Meier Method).
Between day 42 and 18th month (intent-to-treat group), the rate of relapses
and recurrences was significantly higher in the placebo group (36%), than in
the tianeptine group (16%) (p = 0.002). Long term comparison of the rate of
patients without recurrence or relapse, also showed a significant difference
in favour of tianeptine (p < 0.001). The difference between teh 2 groups
increased within time. Secondary analysis of relapses and recurrence in the
intent-to-treat group showed a significantly higher rate of relapses for the
placebo group (p = 0.002); the rate of patients without recurrences in the
long term appeared to be at the limit in the intent-to-treat group (p = 0.067)
but significant in the per-protocol-group, in favour of tianeptine (p = 0.36).
Furthermore, no difference was observed between the 2 groups, in terms of
tolerance. Secondary effects attributed to treatment by investigators were
rare and benign in each group.
CONCLUSIONS: These data support the use of tianeptine in
the long term treatment of unipolar major recurrent depression. Relapses and
recurrences were 2 to 3 times less frequent with tianeptine as compared to
placebo. Furthermore, prolonged treatment with tianeptine appeared to be very
well tolerated.
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