Background: Depression is now seen as a chronic disabling condition that sp
ans the patient's lifetime and creates significant medical, economic and qu
ality of life consequences. Methods: 500 depressed patients were treated wi
th milnacipran for 6 months. A total of 214 recovered patients were randomi
sed to receive either milnacipran (50 mg bid) or a matching placebo for a 1
-year recurrence prevention phase. Recurrence rate was the primary criteria
; quality of life (QoL) consequences were evaluated through a shortened ver
sion of the French Sickness Impact Profile (SIP), the Depression Impact Pro
file (DIP). Results: Milnacipran demonstrated its ability to reduce recurre
nces (Odds-Ratio = 1.5; P < 0.05), with a more marked effect in recovered p
atients with few residual symptoms (Odds-Ratio = 3.0). Responders who conti
nued treatment with milnacipran had a dramatic improvement in their quality
of life, although patients with residual symptoms still experienced some d
eterioration in their QoL (recreation, emotional, social, alertness and hom
e assistance scores). Even recovered patients having zero scores on the Ham
ilton Depression Rating Scale-21 items (HDRS) had some QoL deterioration. T
he DIP emotional score was found to be more predictive of recurrence than t
he HDRS. Overall, the QoL was improved for those in the milnacipran group i
n comparison to placebo on the mobility, communication, psychosocial and to
tal scores. Limitations: The QoL evaluation was a secondary criteria; no a
priori sample size estimate was performed. The choice of a generic QoL inst
rument might have reduced the sensitivity to clinical changes in depression
. Conclusions: prevention of recurrence in MDD with milnacipran contributes
to an improvement in the QoL. (C) 2000 Elsevier Science B.V. All rights re
served.