BACKGROUND: This study compares the efficacy and tolerability of 12 weeks of open-label duloxetine in adult outpatients with anxious versus non-anxious depression. METHODS:Participants in a major depressive episode (N=249) beganduloxetine treatment at 30 or 60 mg daily for the first week, followed by up to 11 weeks of flexibly dosed duloxetine (60, 90, or 120 mg daily). Efficacy measures included HAMD17, HAMA, and CGI-S. Safety and tolerability were assessed by early discontinuation and adverse event rates. Anxious depression was defined by a HAMD17 Anxiety/Somatization Factor score>or=7. RESULTS:Duloxetine treatment was associated with a significantly greater reduction in total HAMD17 scores and HAMD17 Anxiety/Somatization Factor scores among patients with anxious depression compared to non-anxious depression. Differences in CGI-S and HAMA scores at the end of the trial between groups were not statistically significant. Remission and response rates at endpoint were similar between groups, but anxious depressives had a significantly shorter median time to response. Discontinuation rates due to any reason, discontinuation due to adverse events, and treatment-emergent adverse events were similar between groups, except for the significantly greater occurrence of influenza in anxious depressives. CONCLUSIONS:Duloxetine's efficacy in anxious depression was somewhat superior to non-anxious depression; tolerability was comparable between groups.
RCT Entities:
BACKGROUND: This study compares the efficacy and tolerability of 12 weeks of open-label duloxetine in adult outpatients with anxious versus non-anxious depression. METHODS:Participants in a major depressive episode (N=249) began duloxetine treatment at 30 or 60 mg daily for the first week, followed by up to 11 weeks of flexibly dosed duloxetine (60, 90, or 120 mg daily). Efficacy measures included HAMD17, HAMA, and CGI-S. Safety and tolerability were assessed by early discontinuation and adverse event rates. Anxious depression was defined by a HAMD17 Anxiety/Somatization Factor score>or=7. RESULTS:Duloxetine treatment was associated with a significantly greater reduction in total HAMD17 scores and HAMD17 Anxiety/Somatization Factor scores among patients with anxious depression compared to non-anxious depression. Differences in CGI-S and HAMA scores at the end of the trial between groups were not statistically significant. Remission and response rates at endpoint were similar between groups, but anxious depressives had a significantly shorter median time to response. Discontinuation rates due to any reason, discontinuation due to adverse events, and treatment-emergent adverse events were similar between groups, except for the significantly greater occurrence of influenza in anxious depressives. CONCLUSIONS:Duloxetine's efficacy in anxious depression was somewhat superior to non-anxious depression; tolerability was comparable between groups.
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