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Escitalopram for Pancreatic Cancer

Phase 2
Waitlist Available
Led By Jordan Winter, MD
Research Sponsored by Case Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects must not currently be on an antidepressant, anti-anxiety, anti-bipolar, or anti-psychotic medicine
ECOG PS (Eastern Cooperative Oncology Group Performance Status) score of 0-2
Must not have
Metastatic pancreatic or other periampullary cancer
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years from the treatment date
Awards & highlights

Summary

This trial examines whether antidepressants can help reduce symptoms for people with pancreatic or periampullary cancer who are receiving neoadjuvant therapy.

Who is the study for?
This trial is for adults aged 18-80 with localized pancreatic or periampullary cancer, who are not on antidepressants and have an ECOG score of 0-2. They must be mentally competent, able to consent, not planning immediate surgery, and set for neoadjuvant chemotherapy.Check my eligibility
What is being tested?
The study tests if Escitalopram, an antidepressant, helps patients with localized pancreatic cancer undergoing pre-surgery chemo better than a placebo. Participants will either receive the actual drug or a placebo without knowing which one.See study design
What are the potential side effects?
Escitalopram may cause side effects like nausea, sleepiness or insomnia, increased sweating, dry mouth, and sexual dysfunction. It can also affect mood and energy levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am not currently taking any medication for depression, anxiety, bipolar disorder, or psychosis.
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I can take care of myself and am up and about more than half of the day.
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I am scheduled for at least 12 weeks of initial chemotherapy.
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My cancer is confirmed to be in the pancreas or nearby areas.
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I have never been diagnosed with bipolar disorder.
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I am mentally capable and willing to sign a consent form.
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I am between 18 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My cancer has spread from the pancreas or nearby areas.
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I am currently taking medication for depression, anxiety, bipolar disorder, or psychosis, and have not taken MAOIs in the last 6 months.
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I had or will have surgery for pancreatic cancer within the specified time frame.
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I have a history of seizures.
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I am younger than 18 or older than 80.
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I have a history of heart rhythm issues related to long QT syndrome.
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My kidney function is low, with a GFR less than 45.
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I have had a heart attack or unstable heart condition recently.
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My liver disease is moderately to severely advanced.
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I cannot take medicine by mouth.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years from the treatment date
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years from the treatment date for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in the rate of depression
Secondary outcome measures
Quality of Life using FACT-Hep (The Functional Assesment of Cancer Therapy-Hepatobiliary) survey

Side effects data

From 2019 Phase 4 trial • 115 Patients • NCT01902004
23%
Sleepiness/Sedation
10%
Headache
8%
Tension/Inner Unrest
8%
Reduced Salivation
8%
Concentration Difficulties
8%
Diminished Sexual Drive
6%
Asthenia/Lassitude/Increased Fatigability
6%
Constipation
6%
Polyuria/Polydipsia
6%
Orthostatic Dizziness
4%
Nausea/Vomiting
4%
Erectile Dysfunction
4%
Failing Memory
2%
Diarrhea
2%
Increased Duration of Sleep
2%
Reduced Duration of Sleep
2%
Increased Dream Activity
2%
Accomodation Disturbance
2%
Increased Tendancy to Sweating
2%
Weight Gain
2%
Ejaculatory Dysfunction
2%
Micturtion Disturbances
100%
80%
60%
40%
20%
0%
Study treatment Arm
Escitalopram and Placebo
Escitalopram and Memantine

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Participants receiving EscitalopramExperimental Treatment1 Intervention
Group II: Participants receiving PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Escitalopram
2005
Completed Phase 4
~2330

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for pancreatic cancer include surgery, chemotherapy, radiation therapy, and targeted therapy. Chemotherapy drugs, such as gemcitabine and FOLFIRINOX, work by interfering with the DNA replication process in rapidly dividing cancer cells, leading to cell death. Targeted therapies, like erlotinib, inhibit specific molecules involved in tumor growth and progression. While antidepressants are not standard treatments for pancreatic cancer, their modulation of neurotransmitters such as serotonin, norepinephrine, and dopamine can help manage symptoms like pain and depression, which are common in cancer patients. This is crucial as it can improve the overall quality of life and potentially enhance the effectiveness of other cancer treatments by addressing the psychological and neuropathic components of the disease.

Find a Location

Who is running the clinical trial?

Case Comprehensive Cancer CenterLead Sponsor
459 Previous Clinical Trials
32,284 Total Patients Enrolled
Jordan Winter, MDPrincipal InvestigatorCase Comprehensive Cancer Center
2 Previous Clinical Trials

Media Library

Escitalopram Clinical Trial Eligibility Overview. Trial Name: NCT05289830 — Phase 2
Pancreatic Cancer Research Study Groups: Participants receiving Escitalopram, Participants receiving Placebo
Pancreatic Cancer Clinical Trial 2023: Escitalopram Highlights & Side Effects. Trial Name: NCT05289830 — Phase 2
Escitalopram 2023 Treatment Timeline for Medical Study. Trial Name: NCT05289830 — Phase 2
~1 spots leftby Jul 2025