A randomized, controlled trial of duloxetine alone vs. duloxetine plus a telephone intervention in the treatment of depression

Perahia, David G.S., Quail, Deborah, Gandhi, Paul, Walker, Daniel J. and Peveler, Robert C. (2008) A randomized, controlled trial of duloxetine alone vs. duloxetine plus a telephone intervention in the treatment of depression. Journal of Affective Disorders, 108 (1-2), 33-41. (doi:10.1016/j.jad.2007.08.023).

Abstract

Objective
We hypothesized that combining antidepressant medication with a standardized telephone adherence support intervention would lead to superior outcomes in the treatment of depression compared with antidepressant medication alone.

Method
Patients with depression were randomized to receive the antidepressant duloxetine alone (DLX), or duloxetine plus a standardized telephone intervention (DLX + TI), for 12 weeks of open-label treatment. The primary outcome measure was remission (HAMD17 total score ? 7) at study endpoint. Safety and tolerability were assessed via reporting of treatment-emergent adverse events (AEs), vital signs and laboratory measures. The TI was delivered approximately 1, 4, and 9 weeks after initiation of duloxetine.

Results
The DLX (N = 485) and DLX + TI (N = 477) groups did not differ significantly at baseline. At study endpoint, remission rates (42.8% vs. 43.5%, P = 0.87), response rates (56.6% vs. 58.4%, P = 0.58) and other secondary outcomes were similar between the groups. A similar proportion of patients in each group completed the study, and adverse event discontinuation rates were not significantly different (10.7% vs. 13.0%, P = 0.318). More AEs were reported by patients in the DLX + TI group, however, and constipation (3.5% vs. 10.1%, P < 0.001) and hot flush (0.2% vs. 1.7%, P = 0.020) were reported by more DLX + TI patients. Adherence to medication was high (> 90% at every visit) in both groups.

Conclusions
A telephone intervention in combination with antidepressant medication (duloxetine) did not improve depression outcomes compared with antidepressant alone in this clinical trial, perhaps due to high drug adherence in both treatment groups. Addition of a telephone intervention was, however, associated with increased reporting of AEs.

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Contributors

Author: Robert C. Peveler

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