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

Oct 2, 2007Journal of affective disorders

Depression treatment with duloxetine alone versus duloxetine plus phone support in a controlled trial

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Abstract

Remission rates were 42.8% for duloxetine alone and 43.5% for duloxetine with a telephone intervention, with no significant difference (P=0.87).

Combining a telephone adherence support intervention with duloxetine did not lead to superior remission or response rates compared to duloxetine alone.
Patients in both groups had high medication adherence, exceeding 90% at every visit.
Adverse events were reported more frequently in the group receiving the telephone intervention.
Notable adverse events included higher rates of constipation (10.1% vs. 3.5%) and hot flush (1.7% vs. 0.2%) in the telephone intervention group.
Discontinuation rates due to adverse events were not significantly different between the two groups.

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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 (HAMD 17 total score <or=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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A randomized, controlled trial of duloxetine alone vs. duloxetine plus a telephone intervention in the treatment of depression

Abstract

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