2022-08-05
2023-08-27
2023-08-27
4
NCT05289830
Case Comprehensive Cancer Center
Case Comprehensive Cancer Center
INTERVENTIONAL
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.
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 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Supportive Care
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
Single
Arms and Interventions
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Participants receiving Escitalopram | DRUG: Escitalopram
|
PLACEBO_COMPARATOR: Participants receiving Placebo | OTHER: Placebo
|
Primary Outcome Measures | 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 | 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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:
This is where you will find people and organizations involved with this study.
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