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. 2018 Apr 23;2018(4):CD011006. doi: 10.1002/14651858.CD011006.pub3

EUCTR2008‐002159‐25‐FR.

Methods 12 weeks, randomised, double‐blind, placebo‐controlled study
Participants People with (a) cancer of the upper aerodigestive tract (buccal cavity, larynx, oropharynx, hypopharynx), solitary or multiple synchronous localisations, stage I to IVb, to be treated by surgery and/or radiotherapy and/or chemotherapy (first‐line curative treatment); (b) HADS more than 11 (excluded those with a diagnosis of major depressive episode with severity criteria and/or suicidal thoughts); (c) aged between 18 and 75 years, having signed an informed consent
Interventions Escitalopram: 20 participants
Placebo: 18 participants
Outcomes Primary outcome: subscore depression of the HADS, W12
Secondary outcomes: CES‐D; MADRS; CGI; SCL‐90‐R; health‐related quality of life (EORTC QLQC‐30, H‐N 35), alcohol or tobacco consumption (CO, CDT)
Notes Data were partially provided by the authors before the publication of the study
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not reported (unpublished study)
Allocation concealment (selection bias) Unclear risk Not reported (unpublished study)
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Not reported (unpublished study)
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Not reported (unpublished study)
Incomplete outcome data (attrition bias) 
 All outcomes High risk Dropout rate: escitalopram arm 4/20 (20%); placebo arm 3/18 (16.7%). Only participants who completed the assessment at each time point were analysed and missing data were not imputed ('per protocol' analysis).
Selective reporting (reporting bias) Low risk Prespecified outcomes are reported for the endpoint assessment (week 12) and for week 4.
Other bias Low risk The baseline features of the population of the study are not reported. The Gustave Roussy, which is a private non‐profit hospital, was the sponsor of the trial. Lundbeck funded only the costs of drugs and did not play any role in planning, conducting and writing the study.