Trial Outcomes & Findings for Escitalopram to Placebo in Patients With Localized Pancreatic Cancer (NCT NCT05289830)
NCT ID: NCT05289830
Last Updated: 2025-12-10
Results Overview
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.
TERMINATED
PHASE2
4 participants
12 weeks from the start of treatment
2025-12-10
Participant Flow
Participant milestones
| Measure |
Participants Receiving Escitalopram
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)
|
Participants Receiving Placebo
Placebo: Participants will receive placebo supplements 2 weeks: 1 capsule 8 weeks: 2 capsules 2 weeks: 1 capsule
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
|
Overall Study
COMPLETED
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Participants Receiving Escitalopram
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)
|
Participants Receiving Placebo
Placebo: Participants will receive placebo supplements 2 weeks: 1 capsule 8 weeks: 2 capsules 2 weeks: 1 capsule
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Physician Decision
|
0
|
1
|
Baseline Characteristics
Escitalopram to Placebo in Patients With Localized Pancreatic Cancer
Baseline characteristics by cohort
| Measure |
Participants Receiving Escitalopram
n=2 Participants
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)
|
Participants Receiving Placebo
n=2 Participants
Placebo: Participants will receive placebo supplements 2 weeks: 1 capsule 8 weeks: 2 capsules 2 weeks: 1 capsule
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=4 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=681 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=4 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=681 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=4 Participants
|
2 Participants
n=50 Participants
|
4 Participants
n=681 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=4 Participants
|
1 Participants
n=50 Participants
|
1 Participants
n=681 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=4 Participants
|
1 Participants
n=50 Participants
|
3 Participants
n=681 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=4 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=681 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=4 Participants
|
2 Participants
n=50 Participants
|
4 Participants
n=681 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=4 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=681 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=4 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=681 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=4 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=681 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=4 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=681 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=4 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=681 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=4 Participants
|
2 Participants
n=50 Participants
|
4 Participants
n=681 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=4 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=681 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=4 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=681 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=4 Participants
|
2 participants
n=50 Participants
|
4 participants
n=681 Participants
|
PRIMARY outcome
Timeframe: 12 weeks from the start of treatmentPopulation: 1 participant in Arm 1 and 2 participants in Arm 2 were not evaluable at 12 weeks and did not complete the study
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.
Outcome measures
| Measure |
Participants Receiving Escitalopram
n=1 Participants
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)
|
Participants Receiving Placebo
Placebo: Participants will receive placebo supplements 2 weeks: 1 capsule 8 weeks: 2 capsules 2 weeks: 1 capsule
|
|---|---|---|
|
Change in the Rate of Depression
|
13 QIDS score
|
—
|
SECONDARY outcome
Timeframe: Up to 12 weeks from the treatment datePopulation: 1 participant in Arm 1 and 2 participants in Arm 2 were not evaluable at 12 weeks and did not complete the study
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. Scores range from 0 to 180.
Outcome measures
| Measure |
Participants Receiving Escitalopram
n=1 Participants
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)
|
Participants Receiving Placebo
Placebo: Participants will receive placebo supplements 2 weeks: 1 capsule 8 weeks: 2 capsules 2 weeks: 1 capsule
|
|---|---|---|
|
Quality of Life Using FACT-Hep (The Functional Assesment of Cancer Therapy-Hepatobiliary) Survey
|
90 FACTS score
|
—
|
Adverse Events
Participants Receiving Escitalopram
Participants Receiving Placebo
Serious adverse events
| Measure |
Participants Receiving Escitalopram
n=2 participants at risk
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)
|
Participants Receiving Placebo
n=2 participants at risk
Placebo: Participants will receive placebo supplements 2 weeks: 1 capsule 8 weeks: 2 capsules 2 weeks: 1 capsule
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/2 • 25 weeks
|
50.0%
1/2 • 25 weeks
|
|
Gastrointestinal disorders
Nausea
|
50.0%
1/2 • 25 weeks
|
50.0%
1/2 • 25 weeks
|
|
Metabolism and nutrition disorders
Acidosis
|
50.0%
1/2 • 25 weeks
|
0.00%
0/2 • 25 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/2 • 25 weeks
|
50.0%
1/2 • 25 weeks
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/2 • 25 weeks
|
50.0%
1/2 • 25 weeks
|
|
General disorders
Disease progression
|
0.00%
0/2 • 25 weeks
|
50.0%
1/2 • 25 weeks
|
Other adverse events
| Measure |
Participants Receiving Escitalopram
n=2 participants at risk
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)
|
Participants Receiving Placebo
n=2 participants at risk
Placebo: Participants will receive placebo supplements 2 weeks: 1 capsule 8 weeks: 2 capsules 2 weeks: 1 capsule
|
|---|---|---|
|
Investigations
Alkaline phosphatase increased
|
50.0%
1/2 • 25 weeks
|
0.00%
0/2 • 25 weeks
|
|
Investigations
Aspartate aminotransferase increased
|
50.0%
1/2 • 25 weeks
|
0.00%
0/2 • 25 weeks
|
|
Investigations
Alanine aminotransferase increased
|
50.0%
1/2 • 25 weeks
|
0.00%
0/2 • 25 weeks
|
|
Investigations
Blood bilirubin increased
|
50.0%
1/2 • 25 weeks
|
50.0%
1/2 • 25 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
50.0%
1/2 • 25 weeks
|
0.00%
0/2 • 25 weeks
|
|
Vascular disorders
Hypotension
|
50.0%
1/2 • 25 weeks
|
0.00%
0/2 • 25 weeks
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
50.0%
1/2 • 25 weeks
|
0.00%
0/2 • 25 weeks
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
50.0%
1/2 • 25 weeks
|
0.00%
0/2 • 25 weeks
|
|
Investigations
White blood cell decreased
|
50.0%
1/2 • 25 weeks
|
0.00%
0/2 • 25 weeks
|
|
Nervous system disorders
Dizziness
|
0.00%
0/2 • 25 weeks
|
50.0%
1/2 • 25 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/2 • 25 weeks
|
50.0%
1/2 • 25 weeks
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/2 • 25 weeks
|
50.0%
1/2 • 25 weeks
|
|
Psychiatric disorders
Suicidal ideation
|
50.0%
1/2 • 25 weeks
|
0.00%
0/2 • 25 weeks
|
|
Investigations
Weight loss
|
50.0%
1/2 • 25 weeks
|
0.00%
0/2 • 25 weeks
|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
1/2 • 25 weeks
|
50.0%
1/2 • 25 weeks
|
|
Investigations
Lymphocyte count decreased
|
50.0%
1/2 • 25 weeks
|
0.00%
0/2 • 25 weeks
|
|
Metabolism and nutrition disorders
Hypokalemia
|
50.0%
1/2 • 25 weeks
|
50.0%
1/2 • 25 weeks
|
|
Investigations
Creatinine increased
|
50.0%
1/2 • 25 weeks
|
0.00%
0/2 • 25 weeks
|
|
Investigations
Investigations, other- Creatinine clearance
|
50.0%
1/2 • 25 weeks
|
0.00%
0/2 • 25 weeks
|
|
Renal and urinary disorders
Acute kidney injury
|
50.0%
1/2 • 25 weeks
|
0.00%
0/2 • 25 weeks
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
50.0%
1/2 • 25 weeks
|
50.0%
1/2 • 25 weeks
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
50.0%
1/2 • 25 weeks
|
0.00%
0/2 • 25 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
100.0%
2/2 • 25 weeks
|
50.0%
1/2 • 25 weeks
|
|
Gastrointestinal disorders
Vomiting
|
100.0%
2/2 • 25 weeks
|
50.0%
1/2 • 25 weeks
|
|
Nervous system disorders
Dysgeusia
|
50.0%
1/2 • 25 weeks
|
0.00%
0/2 • 25 weeks
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/2 • 25 weeks
|
50.0%
1/2 • 25 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
50.0%
1/2 • 25 weeks
|
100.0%
2/2 • 25 weeks
|
|
Metabolism and nutrition disorders
Anorexia
|
50.0%
1/2 • 25 weeks
|
100.0%
2/2 • 25 weeks
|
|
Psychiatric disorders
Insomnia
|
50.0%
1/2 • 25 weeks
|
50.0%
1/2 • 25 weeks
|
|
General disorders
Fatigue
|
50.0%
1/2 • 25 weeks
|
50.0%
1/2 • 25 weeks
|
|
Gastrointestinal disorders
Constipation
|
50.0%
1/2 • 25 weeks
|
100.0%
2/2 • 25 weeks
|
|
Metabolism and nutrition disorders
Hyponatremia
|
50.0%
1/2 • 25 weeks
|
50.0%
1/2 • 25 weeks
|
|
Gastrointestinal disorders
Nausea
|
50.0%
1/2 • 25 weeks
|
100.0%
2/2 • 25 weeks
|
|
Psychiatric disorders
Depression
|
50.0%
1/2 • 25 weeks
|
0.00%
0/2 • 25 weeks
|
Additional Information
Dr. Jordan Winter
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place