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 |
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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) |
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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Random sequence generation (selection bias) | Unclear risk | Not reported (unpublished study) |
Allocation concealment (selection bias) | Unclear risk | Not reported (unpublished study) |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not reported (unpublished study) |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported (unpublished study) |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. |