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.

Study Overview

• Status: Terminated
• Conditions: Periampullary Cancer; Pancreatic Ductal Adenocarcinoma
• Intervention / Treatment: Drug: Escitalopram; Other: Placebo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Participants receiving Placebo	Other: Placebo; Participants will receive placebo supplements 2 weeks: 1 capsule 8 weeks: 2 capsules 2 weeks: 1 capsule
Experimental: Participants receiving Escitalopram	Drug: Escitalopram; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the Rate of Depression	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.	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. Scores range from 0 to 180.	Up to 12 weeks from the treatment date

Collaborators and Investigators

• Sponsor: Case Comprehensive Cancer Center
• Investigators: Principal Investigator: Jordan Winter, MD, Case Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2022
• Primary Completion (Actual): August 27, 2023
• Study Completion (Actual): August 27, 2023

Study Registration Dates

• First Submitted: March 11, 2022
• First Submitted That Met QC Criteria: March 11, 2022
• First Posted (Actual): March 21, 2022

Study Record Updates

• Last Update Posted (Actual): December 10, 2025
• Last Update Submitted That Met QC Criteria: November 25, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Amines; Nitriles; Propylamines; Benzofurans; Escitalopram
• Other Study ID Numbers: CASE6220

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: plan to publish the results
• IPD Sharing Time Frame: 4 years to publication
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No