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Escitalopram to Placebo in Patients With Localized Pancreatic Cancer


2022-08-05


2023-08-27


2023-08-27


4

Study Overview

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.

  • Pancreatic Ductal Adenocarcinoma
  • Periampullary Cancer
  • DRUG: Escitalopram
  • OTHER: Placebo
  • CASE6220

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2022-03-11  

N/A  

2024-06-17  

2022-03-11  

N/A  

2024-06-18  

2022-03-21  

N/A  

2024-06  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Supportive Care


Allocation:
Randomized


Interventional Model:
Parallel


Masking:
Single


Arms and Interventions

Participant Group/ArmIntervention/Treatment
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)
PLACEBO_COMPARATOR: Participants receiving Placebo

OTHER: Placebo

  • Participants will receive placebo supplements 2 weeks: 1 capsule 8 weeks: 2 capsules 2 weeks: 1 capsule
Primary Outcome MeasuresMeasure DescriptionTime Frame
Change in the rate of depressionThe 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 MeasuresMeasure DescriptionTime Frame
Quality of Life using FACT-Hep (The Functional Assesment of Cancer Therapy-Hepatobiliary) surveyThe 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 lifeUp to 3 years from the treatment date

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.


    • PRINCIPAL_INVESTIGATOR: Jordan Winter, MD, Case Comprehensive Cancer Center

    Publications

    The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

    General Publications

    No publications available