Escitalopram to Placebo in Patients With Localized Pancreatic Cancer

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

Use of antidepressants for participants with localized pancreatic and periampullary cancer receiving neoadjuvant therapy.

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.

Inclusion Criteria:

1. Subjects must have histologically or cytologically confirmed localized or locally advanced pancreatic ductal adenocarcinoma or other periampullary adenocarcinoma (bile duct, duodenal, ampullary)
2. Subjects must not currently be on an antidepressant, anti-anxiety, anti-bipolar, or anti-psychotic medicine
3. Aged 18-80 years.
4. ECOG PS (Eastern Cooperative Oncology Group Performance Status) score of 0-2
5. Planned to have at least 12 weeks of neoadjuvant chemotherapy as standard of care cancer treatment
6. No diagnosis of bipolar disease
7. Willing to comply with all study procedures and be available for the duration of the study
8. Subjects must be mentally competent and must have the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

1. Patients under the age of 18 or over 80

2. Metastatic pancreatic or other periampullary cancer

3. Resection of pancreatic cancer within the past year prior to study enrollment or planned surgery within the next 12 weeks.

4. 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.

5. Patients with a history of seizure disorder

6. Patients with a recent medical history of myocardial infarction or unstable heart disease

7. Patients with a history of QTc prolongation or torsade de points, a baseline QTc

   1. interval of > 500ms, a history of drug-induced QTc prolongation or congenital long QT
   2. syndrome

8. Patients with Child-Pugh score of B or C

9. Patients with moderate to severe renal disease with a GFR (glomerular filtration rate) < 45.

10. Patients who cannot ingest oral medication

11. Patients with any history of mania

12. Known allergy to escitalopram

13. Pregnancy or lactation