Clinical trial · Interventional
Pilot Study to Evaluate Individualized Choice of Antidepressants in Patients With Cancer
A Pilot Study to Evaluate Individualized Choice of Antidepressant in Patients With Cancer
NCT01725048CI-TRIAL-00026418NRRcompletedEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a pilot study to test the hypothesis that the antidepressants mirtazapine and citalopram are effective treatment for major depressive disorder (MDD) in cancer patients.
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 |
|---|---|---|---|
| Major Depressive Disorder | — | UNRESOLVED | — |
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Citalopram | Drug | — | UNRESOLVED |
| Mirtazapine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Mirtazapine
- description
- Treatment with oral mirtazapine, dosed once daily, for 9 weeks, with starting dose of 7.5 milligrams (mg) daily up to 30mg daily.
- interventionNames
- Drug: Mirtazapine
- type
- ACTIVE_COMPARATOR
- label
- Citalopram
- description
- Treatment with Citalopram, once daily, for 9 weeks, with dosages starting at 10mg once daily to 40mg once daily.
- interventionNames
- Drug: Citalopram
Primary outcomes (1)
- measure
- Feasibility
- timeFrame
- One year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosed with a malignancy * Informed consent obtained and signed * Greater than or equal to 18 years of age * Life expectancy determined to be greater than or equal to 6 months * Diagnosed with Major Depressive Disorder based on clinical examination and the DSM-IV-TR criteria * PHQ-9 depression assessment completed by subject, with a score of 10 or greater * Able to take whole or crushed tablets by mouth or by feeding tube Exclusion Criteria: * Unable to complete self-report instruments due to illiteracy, neurologic illness, visual problems, inability to speak or read English, or other causes * Treatment with antidepressants or antipsychotics within the last 3 months * Psychotic or manic behavior * Active suicidal ideation or plan * Current illicit substance abuse * Severe renal impairment as defined by creatinine clearance of \<15 milliliters/minute/1.73 meters squared (mL/min/m2) * Severe hepatic impairment as defined by Aspartate Aminotransferase (AST) or alanine aminotransferase (ALT) \>5x the upper limit of normal, or a total bilirubin \> 3.0 milliliters/deciliter (mL/dL) * History of congenital long QT syndrome * Clinically significant congestive heart failure or bradyarrhythmias * Treatment with a concomitant medication that is known to have a strong association with corrected QT interval (QTc) prolongation AND a QTc \>460 for men or \>470 for women. Applicable to the citalopram arm only
References
Publications (1)
- DERIVEDVita G, Compri B, Matcham F, Barbui C, Ostuzzi G. Antidepressants for the treatment of depression in people with cancer. Cochrane Database Syst Rev. 2023 Mar 31;3(3):CD011006. doi: 10.1002/14651858.CD011006.pub4. PMID 36999619