Background:
Treatment response for melancholic patients may differ from nonmelancholic depressed patients, with broader spectrum antidepressant drugs being required for the melancholic subtype. Outpatients (n = 202) meeting the diagnostic criteria for major depressive disorder (DSM-IV), with HAMD17 >20 and melancholic features, participated in an 8-week, multicenter, open-label, naturalistic, variable dose pilot study (F1J-AY-HMCZ).
Method:
All patients received duloxetine 60 mg/day for the first 4 weeks. In patients not responding by this time, effectiveness of duloxetine treatment was compared between patients who either continued on 60 mg or received a higher, flexible (90-120 mg/ day) dose, for a second 4-week period.
Results:
After the initial 4-week period, 40.6% of patients (n = 82) responded (≥50% reduction from baseline HAMD17) to duloxetine 60 mg/day, and 17.8% (n = 36) achieved formal remission (HAMD17 ≤7) of symptoms. For nonresponders at 4 weeks, no significant differences were detected across the 60-mg and 90- to 120-mg treatment groups in the rates of response (47.9% and 42.9%, respectively) or remission (22.9% and 18.4%) over the next 4 weeks. Overall, 58% of enrolled patients responded to treatment by study completion. Nausea, headache, dry mouth and constipation were the most frequently reported emergent adverse events.
Conclusions:
The overall response rates after 4 and 8 weeks were encouraging for this sample of melancholic patients. In patients who did not respond to duloxetine 60 mg over the first 4 weeks of treatment, increasing to a higher dose in the second month was not associated with any greater clinical benefit.
