A randomized, controlled trial of duloxetine alone vs. duloxetine plus a telephone intervention in the treatment of depression.
J Affect Disord
; 108(1-2): 33-41, 2008 May.
Article
em En
| MEDLINE
| ID: mdl-17905442
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 (HAMD 17 total scoreRESULTS:
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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Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Encaminhamento e Consulta
/
Telefone
/
Tiofenos
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Cooperação do Paciente
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Transtorno Depressivo Maior
/
Antidepressivos
Tipo de estudo:
Clinical_trials
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Diagnostic_studies
/
Observational_studies
/
Prognostic_studies
/
Risk_factors_studies
Limite:
Adult
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Revista:
J Affect Disord
Ano de publicação:
2008
Tipo de documento:
Article
País de afiliação:
Reino Unido