NCT04818099

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 208 (estimated)
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Radiation Injuries

Interventions

Type	Name	Description
DRUG	Vortioxetine 10 mg	Vortioxetine will be used with a dosage of 10mg once a day, for 2 months.
OTHER	Placebo	Placebo will be used with a dosage of one tablet once a day for 2 months.

Timeline

• Start date: 2020-10-10
• Primary completion: 2023-10-10
• Completion: 2024-04-01
• First posted: 2021-03-26
• Last updated: 2021-03-26

Locations

1 site across 1 country: China