A Multicenter, Randomized, Double-blind, Controlled Clinical Trial of Votioxetine in the Treatment of Depression After Radiotherapy for Head and Neck Cancer
试验速览
- 阶段
- 3 期
- 入组人数
- 208
- 试验地点
- 1
- 主要终点
- Change From Baseline to Week 8 in the MADRS Total Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(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</=
- •(4) Estimated life expectancy ≥ 12 months.
- •(5) Constant caregivers who well understand and have willingness to sign a written informed consent document.
排除标准
- •(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.
研究组 & 干预措施
routine supportive psychotherapy and votioxetine
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.
干预措施: Vortioxetine 10 mg (Drug)
routine supportive psychotherapy and control
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.
干预措施: Placebo (Other)
结局指标
主要结局
Change From Baseline to Week 8 in the MADRS Total Score
时间窗: Baseline to Week 8
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.
次要结局
- Change From Baseline to Week 8 in the Digit Symbol Substitution Test (DSST)(Baseline to Week 8)
- Change in the quality of life(Baseline to Week 8)
- Change from baseline to 8 weeks in Rey Auditory Verbal Learning Test (RAVLT)(Baseline to Week 8)
- Percentage of participants with MADRS response at week 8(Baseline to Week 8)
- Change from baseline to 8 weeks in the HAM-A (Hamilton Anxiety Rating Scale)(Baseline to Week 8)
- Dropouts due to inefficacy(Baseline to Week 8)
- Change From Baseline to Week 8 in the Trail Making Test (TMT-A)(Baseline to Week 8)
- Change From Baseline to Week 8 in CGI-S (the Clinical Global Impressions-Severity) Score(Baseline to Week 8)
- Dropouts due to adverse events(Baseline to Week 8)
研究者
Yamei Tang
Professor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University