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

Sun Yat-sen University

Status and phase: Unknown; Phase 3

Conditions: Radiation Injuries

Treatments: Drug: Vortioxetine 10 mg; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04818099

20200813

Details and patient eligibility

About

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.

Full 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.

Enrollment: 208 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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208 participants in 2 patient groups, including a placebo group

routine supportive psychotherapy and votioxetine

Experimental group

Description:

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.

Treatment:

Drug: Vortioxetine 10 mg

routine supportive psychotherapy and control

Placebo Comparator group

Description:

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.

Treatment:

Other: Placebo