Clinical trial · Interventional
Escitalopram to Placebo in Patients With Localized Pancreatic Cancer
A Phase II, Randomized, Double-blind, Trial Comparing Escitalopram to Placebo in Patients With Localized Pancreatic Cancer
NCT05289830CI-TRIAL-00098711terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow accrual
Summary
Brief summary (as posted)
Use of antidepressants for participants with localized pancreatic and periampullary cancer receiving neoadjuvant therapy.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Ductal Adenocarcinoma | Pancreatic Ductal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Periampullary Cancer | Periampullary Adenocarcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Escitalopram | Drug | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Participants receiving Escitalopram
- interventionNames
- Drug: Escitalopram
- type
- PLACEBO_COMPARATOR
- label
- Participants receiving Placebo
- interventionNames
- Other: Placebo
Primary outcomes (1)
- measure
- Change in the Rate of Depression
- timeFrame
- 12 weeks from the start of treatment
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.