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HIV Clin Trials. 2014 Jul-Aug;15(4):161-75. doi: 10.1310/hct1504-161.

Citalopram for the prevention of depression and its consequences in HIV-hepatitis C coinfected individuals initiating pegylated interferon/ribavirin therapy: a multicenter randomized double-blind placebo-controlled trial.

Author information

1
Division of Infectious Diseases/Chronic Viral Illness Service, Department of Medicine, Royal Victoria Hospital, McGill University Health Centre, Montréal, Québec, Canada Canadian HIV Trials Network, Vancouver, British Columbia, Canada.
2
Canadian HIV Trials Network, Vancouver, British Columbia, Canada.
3
Division of Infectious Diseases/Chronic Viral Illness Service, Department of Medicine, Royal Victoria Hospital, McGill University Health Centre, Montréal, Québec, Canada Department of Psychiatry, McGill University, Montréal, Québec, Canada Royal Victoria Hospital, McGill University Health Centre, Montréal, Québec, Canada.
4
Division of Infectious Diseases/Chronic Viral Illness Service, Department of Medicine, Royal Victoria Hospital, McGill University Health Centre, Montréal, Québec, Canada Department of Pharmacy, McGill University Health Centre, Montréal, Québec, Canada Faculté de Pharmacie, Université de Montréal, Montréal, Québec, Canada.
5
Canadian HIV Trials Network, Vancouver, British Columbia, Canada University Health Network, University of Toronto, Toronto, Ontario, Canada.
6
University Health Network, University of Toronto, Toronto, Ontario, Canada.
7
Vancouver Infectious Diseases Research and Care Centre, Vancouver, British Columbia, Canada.
8
BC Centre for Excellence in HIV/AIDS, Vancouver, British Columbia, Canada.
9
Canadian HIV Trials Network, Vancouver, British Columbia, Canada The Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
10
McMaster Health Science Centre, Hamilton, Ontario, Canada.
11
Clinique médicale l'Actuel (VIH ITS Hépatites), Montréal, Québec, Canada Centre hospitalier de l'université de Montréal, Montréal, Québec, Canada.
12
Department of Psychiatry, McGill University, Montréal, Québec, Canada.
13
Department of Psychiatry, McGill University, Montréal, Québec, Canada Royal Victoria Hospital, McGill University Health Centre, Montréal, Québec, Canada.

Abstract

BACKGROUND:

Depression related to interferon-alpha (IFN-α) is common, may reduce adherence, and can be treatment limiting. HIV-HCV coinfected persons experience lower sustained virologic response rates and commonly have psychiatric comorbidities, thus they may benefit from prevention of depression.

OBJECTIVE:

The aim of the study was to determine whether prophylactic citalopram can increase HCV treatment adherence and reduce the incidence of moderate depression in HIV-HCV coinfected patients initiating PEG-IFN-α/ribavirin therapy.

METHODS:

This was an investigator-initiated Canadian multicenter randomized, double-blind placebo-controlled trial. HIV-HCV coinfected patients were randomized in a 1:1 ratio to receive citalopram or placebo 3 weeks prior to starting PEG-IFN-α2b/ribavirin, stratified by study center and HCV genotype. The protocol design permitted the comparison of prophylaxis with the treatment of emergent depression. The primary outcomes were adherence (assessed through questionnaire and returned medication) and time to moderate depression measured by Beck Depression Inventory-II (BDI- II) score greater than 15, confirmed 2 weeks apart.

RESULTS:

Seventy-six patients (36 citalopram/40 placebo) were randomized. Overall adherence was high, ranging from 95% (week 12) to 91% (week 48). There was no difference between arms with respect to mean or median adherence at any study time point. Cumulative incidence of moderate depression did not differ significantly by group (log rank P = .32). The hazard ratio for moderate depression was 0.81 (95% CI, 0.26 to 2.54) for citalopram compared with placebo when adjusted for baseline BDI-II score.

CONCLUSIONS:

A strategy of prophylactic citalopram compared to treatment of emergent depression was not associated with higher adherence or a reduction in treatment-limiting depression nor did it significantly reduce depressive symptoms among HIV-HCV coinfected persons during treatment for HCV.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00317746.

KEYWORDS:

HIV; citalopram; coinfection; depression; hepatitis C virus; interferon-alpha

PMID:
25143025
DOI:
10.1310/hct1504-161
[Indexed for MEDLINE]
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