A Phase II, Randomized, Double-blind, Trial Comparing Escitalopram to Placebo in Patients With Localized Pancreatic Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Change in the Rate of Depression
研究概览
简要总结
Use of antidepressants for participants with localized pancreatic and periampullary cancer receiving neoadjuvant therapy.
详细描述
Anti-depressants have been shown to be beneficial in cancer participants. They reduce depressive symptoms and improve quality of life. Randomized trials have shown that antidepressants can reduce the development of depression in non-depressed participants with breast, melanoma, and head and neck cancers. It has been shown that treating depression can impact survival in cancer participants. Additionally, depressed pancreatic cancer participants have worse survival. Therefore, anti-depressants may also have implications for cancer treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must have histologically or cytologically confirmed localized or locally advanced pancreatic ductal adenocarcinoma or other periampullary adenocarcinoma (bile duct, duodenal, ampullary)
- •Subjects must not currently be on an antidepressant, anti-anxiety, anti-bipolar, or anti-psychotic medicine
- •Aged 18-80 years.
- •ECOG PS (Eastern Cooperative Oncology Group Performance Status) score of 0-2
- •Planned to have at least 12 weeks of neoadjuvant chemotherapy as standard of care cancer treatment
- •No diagnosis of bipolar disease
- •Willing to comply with all study procedures and be available for the duration of the study
- •Subjects must be mentally competent and must have the ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Patients under the age of 18 or over 80
- •Metastatic pancreatic or other periampullary cancer
- •Resection of pancreatic cancer within the past year prior to study enrollment or planned surgery within the next 12 weeks.
- •Currently on an antidepressant, anti-anxiety, anti-bipolar or anti-psychotic medicine. Patients who have taken MAOIs (Monoamine Oxidase Inhibitors) within the past 6 months are excluded.
- •Patients with a history of seizure disorder
- •Patients with a recent medical history of myocardial infarction or unstable heart disease
- •Patients with a history of QTc prolongation or torsade de points, a baseline QTc
- •interval of > 500ms, a history of drug-induced QTc prolongation or congenital long QT
- •Patients with Child-Pugh score of B or C
- •Patients with moderate to severe renal disease with a GFR (glomerular filtration rate) <
- •Patients who cannot ingest oral medication
- •Patients with any history of mania
- •Known allergy to escitalopram
- •Pregnancy or lactation
研究组 & 干预措施
Participants receiving Escitalopram
干预措施: Escitalopram (Drug)
Participants receiving Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Change in the Rate of Depression
时间窗: 12 weeks from the start of treatment
Rate of depression will be measured using the Quick Inventory of Depressive Symptoms (QIDS) survey. This survey has 16 questions that are specific to the symptomatology of depression. Answers are given in the form of a four-point Likert scale ranging from 0-3, with zero relating to a standard sense of well-being and three correlating to the greatest feelings of depression. The survey is divided into 9 domains, and the survey is scored by adding the highest score on any one of the questions in each of the domains. Total scores range from 0 to 27, with greater scores indicating greater symptoms of depression.
次要结局
- Quality of Life Using FACT-Hep (The Functional Assesment of Cancer Therapy-Hepatobiliary) Survey(Up to 12 weeks from the treatment date)