A double-blind six months comparative study of
milnacipran and clomipramine in major depressive disorder.
Steen A, Den Boer JA.
Psychiatric Hospital Zon en Schild
Amersfoort, The Netherlands.
Int Clin Psychopharmacol. 1997 Sep;12(5):269-81
Abstract
Milnacipran is a new antidepressant with similar effects
on the reuptake of noradrenaline and serotonin in vivo and in vitro. The
present study was designed to study the efficacy and tolerability of
long-term treatment of depressed patients with milnacipran in comparison
with clomipramine. The study was designed as a double-blind, randomized
parallel group comparison at 10 different hospitals in The Netherlands.
The duration of treatment was 6 weeks, with an extension period of 20
weeks. The entire study period of 26 weeks was done under double-blind
conditions. There was 1 week of dose escalation after which the patients
received either treatment with milnacipran 200 mg/day or clomipramine
150 mg/day in fixed doses during weeks 2 to 10. This was followed by
flexible dosing with 200, 150, or 100 mg/day milnacipran or 150, 100 or
75 mg/day clomipramine during weeks 11 to 26. Both milnacipran and
clomipramine showed poor antidepressant activity in this patient sample.
There were no significant differences between the two treatment groups
with respect to antidepressant efficacy. Several methodological reasons
might explain the lack of antidepressant efficacy in the present study.
In 45% of the patients in the present study, the duration of the current
episode of depression was longer than 6 months, whereas 48% of the
patients used antidepressants before the study and 73% of these appeared
to be non-responders. This raises the possibility that the present
sample consisted of treatment-resistant depressive patients.
