The purpose of this study is to evaluate the effects of vortioxetine, once daily (QD), on mood disorders and cognitive dysfunction in patients with head and neck cancers undergoing radiotherapy.
Head and neck cancer (HNC) is the fifth most common cancer in the world, especially in South China. The incidence of depression and anxiety in HNC patients after radiotherapy is as high as 12% - 45% due to appearance changes, decreased swallowing function, dry mouth, pain and other discomfort. At the same time, radiotherapy, as mainstay of therapy for HNC, also causes different degrees of damage to the brain around the tumor, leading to secondary cognitive dysfunction. Depression, anxiety and cognitive impairment seriously affect the quality of life of HNC patients after radiotherapy. Recent studies have found that votioxetine has multimodal pharmacodynamic activity, which can not only improve symptoms of depression, but also significantly improve the cognitive function of patients. In this study, investigators will discuss the therapeutic effect of vortioxetine on the depression after radiotherapy in HNC patients through a multi-center, randomized and double-blind comparative clinical trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
208
Vortioxetine will be used with a dosage of 10mg once a day, for 2 months.
Placebo will be used with a dosage of one tablet once a day for 2 months.
Sun Yat-Sen Memorial Hospital
Guangzhou, Guangdong, China
RECRUITINGChange From Baseline to Week 8 in the MADRS Total Score
MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms with a total possible score range from 0 to 60. Higher scores indicate greater severity of symptoms.
Time frame: Baseline to Week 8
Change From Baseline to Week 8 in the Digit Symbol Substitution Test (DSST)
The DSST assesses relative contributions of speed, memory, executive function and visual scanning. Higher scores-correct number of symbols reflects greater objective cognitive functioning.
Time frame: Baseline to Week 8
Change from baseline to 8 weeks in Rey Auditory Verbal Learning Test (RAVLT)
The purpose of the RAVLT is to assess verbal learning and memory. Specifically, it assesses immediate memory span, new learning, susceptibility to interference, and recognition memory.
Time frame: Baseline to Week 8
Change From Baseline to Week 8 in the Trail Making Test (TMT-A)
TMT-A assesses cognitive processing speed and consists of 25 circles distributed over a sheet of paper. Lower scores represent better speed of processing.
Time frame: Baseline to Week 8
Percentage of participants with MADRS response at week 8
MADRS response was defined as a ≥50% decrease in MADRS total score from baseline
Time frame: Baseline to Week 8
Change from baseline to 8 weeks in the HAM-A (Hamilton Anxiety Rating Scale)
HAM-A is a widely used and well-validated tool for measuring the severity of a patient's anxiety, Higher scores indicate greater severity of symptoms.
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Time frame: Baseline to Week 8
Change in the quality of life
Change from baseline to 8 weeks and endpoint mean scores in FACT-H\&N (the Functional Assessment of Cancer Therapy-Head and Neck) Scale，Higher scores indicate greater severity of symptoms.
Time frame: Baseline to Week 8
Change From Baseline to Week 8 in CGI-S (the Clinical Global Impressions-Severity) Score
The CGI-S assesses the clinician's impression of the subject's current state of mental illness and consists of one question for the investigator: "Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?" which is rated on a seven-point scale (1=normal, not ill at all; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill).
Time frame: Baseline to Week 8
Dropouts due to adverse events
Number of participants who dropped out due to adverse events during the trial
Time frame: Baseline to Week 8
Dropouts due to inefficacy
Number of participants who dropped out due to inefficacy during the trial
Time frame: Baseline to Week 8