PMID- 17905442
OWN - NLM
STAT- MEDLINE
DCOM- 20080605
LR  - 20220408
IS  - 0165-0327 (Print)
IS  - 0165-0327 (Linking)
VI  - 108
IP  - 1-2
DP  - 2008 May
TI  - A randomized, controlled trial of duloxetine alone vs. duloxetine plus a 
      telephone intervention in the treatment of depression.
PG  - 33-41
AB  - 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.
FAU - Perahia, David G S
AU  - Perahia DG
AD  - Lilly Research Centre, Windlesham, UK. d.perahia@lilly.com
FAU - Quail, Deborah
AU  - Quail D
FAU - Gandhi, Paul
AU  - Gandhi P
FAU - Walker, Daniel J
AU  - Walker DJ
FAU - Peveler, Robert C
AU  - Peveler RC
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20071001
PL  - Netherlands
TA  - J Affect Disord
JT  - Journal of affective disorders
JID - 7906073
RN  - 0 (Antidepressive Agents)
RN  - 0 (Thiophenes)
RN  - 9044SC542W (Duloxetine Hydrochloride)
SB  - IM
MH  - Adult
MH  - Ambulatory Care
MH  - Antidepressive Agents/*administration & dosage/adverse effects
MH  - Combined Modality Therapy
MH  - Depressive Disorder, Major/diagnosis/*drug therapy/psychology
MH  - Duloxetine Hydrochloride
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - *Patient Compliance
MH  - Personality Inventory
MH  - *Referral and Consultation
MH  - *Telephone
MH  - Thiophenes/*administration & dosage/adverse effects
MH  - Treatment Outcome
EDAT- 2007/10/02 09:00
MHDA- 2008/06/06 09:00
CRDT- 2007/10/02 09:00
PHST- 2007/02/09 00:00 [received]
PHST- 2007/08/29 00:00 [revised]
PHST- 2007/08/30 00:00 [accepted]
PHST- 2007/10/02 09:00 [pubmed]
PHST- 2008/06/06 09:00 [medline]
PHST- 2007/10/02 09:00 [entrez]
AID - S0165-0327(07)00307-2 [pii]
AID - 10.1016/j.jad.2007.08.023 [doi]
PST - ppublish
SO  - J Affect Disord. 2008 May;108(1-2):33-41. doi: 10.1016/j.jad.2007.08.023. Epub 
      2007 Oct 1.