Escitalopram to Placebo in Patients With Localized Pancreatic Cancer

Study Overview
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Brief Summary
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Use of antidepressants for participants with localized pancreatic and periampullary cancer receiving neoadjuvant therapy.

Detailed Description
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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.

Official Title
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A Phase II, Randomized, Double-blind, Trial Comparing Escitalopram to Placebo in Patients With Localized Pancreatic Cancer

Conditions
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Pancreatic Ductal Adenocarcinoma, Periampullary Cancer

Intervention / Treatment
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* Drug: Escitalopram
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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 syndrome Patients with Child-Pugh score of B or C Patients with moderate to severe renal disease with a GFR (glomerular filtration rate) < 45. Patients who cannot ingest oral medication Patients with any history of mania Known allergy to escitalopram Pregnancy or lactation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Participants receiving Escitalopram<br> | Drug: Escitalopram<br>* Participants will receive Escitalopram 2 weeks: 10 mg/day (1 capsule) 8 weeks: 20 mg/day (2 capsules) 2 weeks: 10 mg/day (1 capsule)<br>|
| Placebo Comparator: Participants receiving Placebo<br> | Other: Placebo<br>* Participants will receive placebo supplements 2 weeks: 1 capsule 8 weeks: 2 capsules 2 weeks: 1 capsule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the rate of depression | The 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. Depression is reflected by a score ≥ 11 (moderate depression or worse). | 12 weeks from the start of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life using FACT-Hep (The Functional Assesment of Cancer Therapy-Hepatobiliary) survey | The FACT-Hep has 27 general questions and 18 questions that are specific to hepatopancreatobiliary cancer, for a total of 45 questions. The general questions span four domains: physical, social/family, emotional, and functional well-being 21. It requires less than 10 minutes to complete and targets the 6th-grade reading level. Answers are given in the form of a five-point Likert scale as follows: 0 (Not at all), 1 (A little bit), 2 (Somewhat), 3 (Quite a bit), and 4 (Very much). Points are re-calibrated and compiled, such that high scores indicate a higher quality of life | Up to 3 years from the treatment date |