Escitalopram to Placebo in Patients With Localized Pancreatic Cancer

NCT ID: NCT05289830

Last Updated: 2025-12-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-05
• Study Completion Date: 2023-08-27

Brief Summary

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

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.

Conditions

Pancreatic Ductal Adenocarcinoma; Periampullary Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Participants receiving Escitalopram

Group Type: EXPERIMENTAL

Escitalopram

Intervention Type: DRUG

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)

Participants receiving Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Participants will receive placebo supplements 2 weeks: 1 capsule 8 weeks: 2 capsules 2 weeks: 1 capsule

Interventions

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)

Intervention Type: DRUG

Placebo

Participants will receive placebo supplements 2 weeks: 1 capsule 8 weeks: 2 capsules 2 weeks: 1 capsule

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Case Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jordan Winter, MD

Role: PRINCIPAL_INVESTIGATOR

Case Comprehensive Cancer Center

Locations

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

CASE6220

Identifier Type: -

Identifier Source: org_study_id