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


METHODS
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.
Perahia
David G S
DG
Lilly Research Centre, Windlesham, UK. d.perahia@lilly.com
Quail
Deborah
D
Gandhi
Paul
P
Walker
Daniel J
DJ
Peveler
Robert C
RC
D000328:Adult; D000553:Ambulatory Care; D000928:Antidepressive Agents / Q000008:administration & dosage* / Q000009:adverse effects; D003131:Combined Modality Therapy; D003865:Major Depressive Disorder / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D000068736:Duloxetine Hydrochloride; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D010555:Personality Inventory; D012017:Referral and Consultation; D013689:Telephone; D013876:Thiophenes / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
D000928:Antidepressive Agents; D013876:Thiophenes; D000068736:Duloxetine Hydrochloride