Status:
UNKNOWN
Vortioxetine in the Treatment of Depression Associated With Head and Neck Cancers Undergoing Radiotherapy
Lead Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Collaborating Sponsors:
Sun Yat-sen University
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Conditions:
Radiation Injuries
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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% d...
Eligibility Criteria
Inclusion
- (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
- (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.
Key Trial Info
Start Date :
October 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2024
Estimated Enrollment :
208 Patients enrolled
Trial Details
Trial ID
NCT04818099
Start Date
October 10 2020
End Date
April 1 2024
Last Update
March 26 2021
Active Locations (1)
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1
Sun Yat-Sen Memorial Hospital
Guangzhou, Guangdong, China, 510120