Clinical trial · Interventional
Effectiveness of Escitalopram in Preventing or Reducing Depressive Symptoms in People Receiving Interleukin-2 Treatment
IL-2 Neuropsychiatric Symptoms: Mechanism and Prevention
NCT00352885CI-TRIAL-00034881completedPhase 4Results postedClinicalTrials.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 study will determine the effectiveness of an antidepressant in preventing or reducing depressive symptoms in people with melanoma who are receiving Interleukin-2 (IL-2) treatment.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Depression | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Escitalopram | Drug | — | UNRESOLVED |
| IL-2 | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Escitalopram
- description
- Participants will receive escitalopram and IL-2 treatment
- interventionNames
- Drug: Escitalopram
- Drug: IL-2
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Participants will receive placebo and IL-2 treatment
- interventionNames
- Drug: Placebo
- Drug: IL-2
Primary outcomes (1)
- measure
- Number of IL-2 Treatments Tolerated
- timeFrame
- Cycle 4 (up to 12 weeks of IL-2 treatment)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosed with cancer and beginning Interleukin (IL)-2 treatment * Willing to use an effective form of birth control throughout the study if sexually active Exclusion Criteria: * Diagnosed with major depression or experiencing significant depressive symptoms or a Hamilton Rating Scale-Depression score of 18 or higher * Brain metastases, history of a brain injury, or seizure disorders * Meets Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV criteria for substance abuse or dependence within 3 months of study entry * Suicidal, psychotic, or received psychiatric hospitalization within 12 months of study entry * Past or current history of schizophrenia or bipolar disorder * Pregnant or planning on becoming pregnant within 1 to 2 years * Evidence of untreated or poorly controlled infectious, hormone, heart, blood, kidney, liver, or neurological disease * Use of antidepressants, glucocorticoids, guanethidine, centrally acting alpha-antagonists, beta-blockers, or anticonvulsants * Clinically significant eye abnormalities * A score lower than 28 on the Mini Mental Status Exam (MMSE) * Prior history of severe adverse events associated with escitalopram or other selective serotonin reuptake inhibitor (SSRI) antidepressants * Diagnosed with type 1 or type 2 diabetes * Any condition that might make the participant unsuitable for enrollment or that could interfere with study participation
References
Publications (3)
- RESULTMusselman D, Royster EB, Wang M, Long Q, Trimble LM, Mann TK, Graciaa DS, McNutt MD, Auyeung NS, Oliver L, Lawson DH, Miller AH. The impact of escitalopram on IL-2-induced neuroendocrine, immune, and behavioral changes in patients with malignant melanoma: preliminary findings. Neuropsychopharmacology. 2013 Sep;38(10):1921-8. doi: 10.1038/npp.2013.85. Epub 2013 Apr 10. PMID 23575741
- 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
- DERIVEDMcNutt MD, Liu S, Manatunga A, Royster EB, Raison CL, Woolwine BJ, Demetrashvili MF, Miller AH, Musselman DL. Neurobehavioral effects of interferon-alpha in patients with hepatitis-C: symptom dimensions and responsiveness to paroxetine. Neuropsychopharmacology. 2012 May;37(6):1444-54. doi: 10.1038/npp.2011.330. Epub 2012 Feb 22. PMID 22353759