Behaviors and Mental Disorders

All Conditions

Neoplasms

Wounds and Injuries

Depression

Depressive Disorder

Head and Neck Neoplasms

Radiation Injuries

Behavioral Symptoms

Central Nervous System Depressants

Psychotropic Drugs

All Drugs and Chemicals

Vortioxetine

Antidepressive Agents

Anti-Anxiety Agents

Selective Serotonin Reuptake Inhibitors

Serotonin

Neurotransmitter Agents

Serotonin 5-HT1 Receptor Agonists

Serotonin Receptor Agonists

Serotonin 5-HT3 Receptor Antagonists

On the basis of general psychotherapy, cognitive behavior therapy and supportive psychotherapy, the patients were given votioxetine 10mg/tablet, one tablet each time, once a day, for 2 months.

On the basis of general psychotherapy, cognitive behavior therapy and supportive psychotherapy, the patients were given placebo, one tablet each time, once a day, for 2 months.

Vortioxetine will be used with a dosage of 10mg once a day, for 2 months.

Vortioxetine 10 mg

Placebo will be used with a dosage of one tablet once a day for 2 months.

Placebo

Yamei Tang, M.D.

Yamei Tang

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.

Vortioxetine in the Treatment of Depression Associated With Head and Neck Cancers Undergoing Radiotherapy

A Multicenter, Randomized, Double-blind, Controlled Clinical Trial of Votioxetine in the Treatment of Depression After Radiotherapy for Head and Neck Cancer

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.

The DSST assesses relative contributions of speed, memory, executive function and visual scanning. Higher scores-correct number of symbols reflects greater objective cognitive functioning.

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.

TMT-A assesses cognitive processing speed and consists of 25 circles distributed over a sheet of paper. Lower scores represent better speed of processing.

MADRS response was defined as a ≥50% decrease in MADRS total score from baseline

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.

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.

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).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Vortioxetine in the Treatment of Depression Associated With Head and Neck Cancers Undergoing Radiotherapy	NCT04818099	Radiation Injur...	Vortioxetine 10... Placebo	18 Years - 65 Years	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Vortioxetine in the Treatment of Depression Associated With Head and Neck Cancers Undergoing Radiotherapy	NCT04818099	Radiation Injur...	Vortioxetine 10... Placebo	18 Years - 65 Years	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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