BACKGROUND:Milnacipran is a dual-action antidepressant which inhibits both serotonin and noradrenaline reuptake with no affinity for any neurotransmitter receptor studied. METHODS: A 6-week double-blind multicentre study compared milnacipran (100 mg/day) with paroxetine (20 mg/day) in 300 outpatients with major depression. Efficacy was evaluated using HAMD17, MADRS and CGI for severity of illness and global improvement. Data were analysed on an intention to treat, last observation carried forward, basis. RESULTS:Milnacipran and paroxetine were both effective and well tolerated with no significant difference in their effects. After treatment discontinuation, milnacipran was associated with significantly less emergent symptoms. Responders, at endpoint, to milnacipran had significantly greater levels of psychomotor retardation at baseline than non-responders. LIMITATIONS: The study did not include a placebo group so that it is impossible to determine absolute levels of efficacy. CONCLUSIONS: Both milnacipran and paroxetine were effective and well tolerated by outpatients with major depression treated for 6 weeks. After treatment discontinuation milnacipran was associated with less emergent symptoms. Psychomotor retardation at baseline may be a predictive factor of a favourable response to milnacipran.
RCT Entities:
BACKGROUND:Milnacipran is a dual-action antidepressant which inhibits both serotonin and noradrenaline reuptake with no affinity for any neurotransmitter receptor studied. METHODS: A 6-week double-blind multicentre study compared milnacipran (100 mg/day) with paroxetine (20 mg/day) in 300 outpatients with major depression. Efficacy was evaluated using HAMD17, MADRS and CGI for severity of illness and global improvement. Data were analysed on an intention to treat, last observation carried forward, basis. RESULTS:Milnacipran and paroxetine were both effective and well tolerated with no significant difference in their effects. After treatment discontinuation, milnacipran was associated with significantly less emergent symptoms. Responders, at endpoint, to milnacipran had significantly greater levels of psychomotor retardation at baseline than non-responders. LIMITATIONS: The study did not include a placebo group so that it is impossible to determine absolute levels of efficacy. CONCLUSIONS: Both milnacipran and paroxetine were effective and well tolerated by outpatients with major depression treated for 6 weeks. After treatment discontinuation milnacipran was associated with less emergent symptoms. Psychomotor retardation at baseline may be a predictive factor of a favourable response to milnacipran.