Clinical trial NCT04818099: Vortioxetine in the Treatment of Depression Associated With Head and Neck Cancers Undergoing Radiotherapy
Official title: A Multicenter, Randomized, Double-blind, Controlled Clinical Trial of Votioxetine in the Treatment of Depression After Radiotherapy for Head and Neck Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Radiation Injuries
Keywords: Vortioxetine
Depression
Cognitive function
Head and Neck Cancers
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
Collaborators: name: Sun Yat-sen University
name: Affiliated Cancer Hospital & Institute of Guangzhou Medical University
name: Brain Hospital Affiliated to Guangzhou Medical University
First posted: 2021-03-26
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* (1) Received radiation therapy due to head and neck cancer.
* (2) The patient have depression symptoms (PHQ-9 score ≥ 8) and meet the ICD-10 (version 2019) diagnostic criteria.
* (3) Age\>/= 18 years and age\</=65.
* (4) Estimated life expectancy ≥ 12 months.
* (5) Constant caregivers who well understand and have willingness to sign a written informed consent document.

Exclusion Criteria:

* (1) The researcher believe that the subjects have the tendency of suicide, self mutilation or the score of "suicide concept" in item 10 of MADRS was ≥5, or they had committed suicide, self mutilation within 6 months before enrollment;
* (2) History of depressive disorder before radiotherapy for head and neck tumors;
* (3) History of other serious mental disorders, such as generalized anxiety disorder, drug and alcohol abuse, etc;
* (4) History of central nervous diseases such as Alzheimer's disease, Parkinson's disease, Stroke, uncontrolled epilepsy, etc., which lead to emotional and cognitive impairment and other serious and uncontrolled systemic diseases (such as cardiopulmonary insufficiency, etc.);
* (5) Baseline Mini Mental State Examination (MMSE) score ≤ 23 points (University or above), MMSE ≤ 22 points (middle school), MMSE ≤ 20 points (primary school), MMSE ≤ 17 points (illiteracy);
* (6) The subject with brain metastasis;
* (7) Hematological examination of subject: White blood cell count \< 3.5×10\^9/L, Platelet count \< 100×10\^9/L, Hemoglobin \< 110g/L, Abnormal range of coagulation function like fibrinogen \< 1.5g/L, or other coagulation abnormalities with clinical significance；
* (8) Blood biochemical examination of patients: Total bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT) \> 2.0 x upper limit of normal value, Creatinine \> 1.5x upper limit of normal value, Blood sodium \< 130mmol/L;
* (9) The subject has a history of severe drug allergy or is known to be allergic to any excipient of the test drug;
* (10) The subjects who could not effectively complete the neuropsychological test during the follow-up.

Primary outcomes:
measure: Change From Baseline to Week 8 in the MADRS Total Score
timeFrame: Baseline to Week 8
Secondary outcomes:
measure: Change From Baseline to Week 8 in the Digit Symbol Substitution Test (DSST)
timeFrame: Baseline to Week 8
measure: Change from baseline to 8 weeks in Rey Auditory Verbal Learning Test (RAVLT)
timeFrame: Baseline to Week 8
measure: Change From Baseline to Week 8 in the Trail Making Test (TMT-A)
timeFrame: Baseline to Week 8
measure: Percentage of participants with MADRS response at week 8
timeFrame: Baseline to Week 8
measure: Change from baseline to 8 weeks in the HAM-A (Hamilton Anxiety Rating Scale)
timeFrame: Baseline to Week 8
measure: Change in the quality of life
timeFrame: Baseline to Week 8
measure: Change From Baseline to Week 8 in CGI-S (the Clinical Global Impressions-Severity) Score
timeFrame: Baseline to Week 8
measure: Dropouts due to adverse events
timeFrame: Baseline to Week 8
measure: Dropouts due to inefficacy
timeFrame: Baseline to Week 8
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-Sen Memorial Hospital
state: Guangdong
Study officials:
affiliation: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Yamei Tang
role: PRINCIPAL_INVESTIGATOR
References: