Clinical trial · Interventional
Escitalopram in Treating Depression in Patients With Advanced Lung or Gastrointestinal Cancer
Symptom Management Trial in Cancer Survivors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): DSMB stopped study because placebo arm had more adverse events
Summary
Brief summary (as posted)
RATIONALE: Escitalopram may help improve depression and quality of life in patients with advanced lung or gastrointestinal cancer. It is not yet known whether escitalopram is more effective than a placebo in treating depression in patients with advanced lung or gastrointestinal cancer. PURPOSE: This randomized clinical trial is studying the side effects of escitalopram and to see how well it works compared to a placebo in treating depression in patients with advanced lung or gastrointestinal cancer.
Conditions
Conditions (10)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Depression | — | UNRESOLVED | — |
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Extrahepatic Bile Duct Cancer | Malignant Extrahepatic Bile Duct Neoplasm | ALIAS | 0.90 |
| Fatigue | — | UNRESOLVED | — |
| Gallbladder Cancer | Malignant Gallbladder Neoplasm | CURATED_EXACT | 0.92 |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| escitalopram oxalate | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- PLACEBO_COMPARATOR
- label
- Placebo-Placebo
- description
- Participants in this arm were randomized to receive placebo once daily for the first 4 weeks and placebo once daily for the second 4 weeks
- interventionNames
- Drug: Placebo
- type
- OTHER
- label
- Placebo-Escitalopram
- description
- Participants in this arm were randomized to receive placebo once daily for the first 4 weeks and escitalopram oxalate 10 mg once daily for the second 4 weeks
- interventionNames
- Drug: escitalopram oxalate
- Drug: Placebo
- type
- OTHER
- label
- Escitalopram-Placebo
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 35 Years
- Maximum age
- 85 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of any of the following for at least 4 weeks: * Stage IIIB (with effusions) or stage IV non-small cell lung cancer * Extensive stage small cell lung cancer * Stage III or IV pancreatic cancer * Stage IV liver cancer * Stage III or IV gallbladder cancer * Stage III or IV bile duct cancer * Stage IV esophageal cancer * Stage IV gastric cancer * Second line stage IV colorectal cancer * Meets diagnostic and Statistical Manual of Mental Disorders-4th Edition and Endicott criteria for major depressive disorder * Duration of depressive symptoms ≥ 4 weeks * Hamilton Depression D 17 (HAM-D 17) Scale ≥ 14 * No active suicidality requiring immediate care or psychiatric hospitalization PATIENT CHARACTERISTICS: * Able to swallow pills * No active substance abuse disorder (including alcohol abuse within the past 6 months), psychotic disorder or active psychotic symptoms, organic mental disorders, or bipolar disorder * No clinical or laboratory evidence of hypothyroidism * No hypercalcemia * No severe anemia, defined as hemoglobin \< 10 g/dL * No history of multiple adverse drug reactions or allergy to study drugs * Not pregnant * No history of head trauma * No history of epilepsy PRIOR CONCURRENT THERAPY: * No other concurrent antidepressant medications or psychostimulants
References
Publications (0)
Data not yet available