Escitalopram to Placebo in Patients With Localized Pancreatic Cancer

NCT05289830 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: CASE6220
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pancreatic Ductal Adenocarcinoma; Periampullary Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Quality of Life Using FACT-Hep (The Functional Assesment of Cancer Therapy-Hepatobiliary) Survey

  Up to 12 weeks from the treatment date

Study Arms (2)

Participants receiving Escitalopram

EXPERIMENTAL

Drug: Escitalopram

Participants receiving Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Escitalopram 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 Escitalopram

Placebo OTHER

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

Participants receiving Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients under the age of 18 or over 80
• Metastatic pancreatic or other periampullary cancer
• Resection of pancreatic cancer within the past year prior to study enrollment or planned surgery within the next 12 weeks.
• 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.
• Patients with a history of seizure disorder
• Patients with a recent medical history of myocardial infarction or unstable heart disease
• Patients with a history of QTc prolongation or torsade de points, a baseline QTc
• interval of \> 500ms, a history of drug-induced QTc prolongation or congenital long QT
• syndrome
• Patients with Child-Pugh score of B or C
• Patients with moderate to severe renal disease with a GFR (glomerular filtration rate) \< 45.
• Patients who cannot ingest oral medication
• Patients with any history of mania
• Known allergy to escitalopram
• Pregnancy or lactation

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Interventions

Escitalopram

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

Slow accrual led to early termination. Early termination leading to small numbers of subjects analyzed.

Results Point of Contact

• Title: Dr. Jordan Winter
• Organization: University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Jordan.winter@uhhospitals.org

216-844-5777

Study Officials

• Jordan Winter, MD

  Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2022
• First Posted: March 21, 2022
• Study Start: August 5, 2022
• Primary Completion: August 27, 2023
• Study Completion: August 27, 2023
• Last Updated: December 10, 2025
• Results First Posted: December 10, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: 4 years to publication

Locations

US (1)