Phase 4
Completed N=20
Effectiveness of Escitalopram in Preventing or Reducing Depressive Symptoms in People Receiving Interleukin-2 Treatment
Source: ClinicalTrials.gov NCT00352885 ↗Enrolled (actual)
20
Serious AEs
40.0%
Results posted
Jun 2014
Primary outcomePrimary: Number of IL-2 Treatments Tolerated — 18.4; 19.8 IL-2 treatments
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of IL-2 Treatments Tolerated |
18.4; 19.8 | — |
| SECONDARY Plasma Concentrations of Adrenocorticotropic Hormone (ACTH) |
27.55; 28.95; 45.66; 56.60; 112.59; 75.69 | — |
| SECONDARY Plasma Concentrations of Interleukin 6 (IL-6) |
11.68; 10.12; 290.77; 270.11; 210.90; 297.94 | — |
| SECONDARY Plasma Concentrations of Cortisol |
11.51; 10.62; 20.60; 17.78; 19.53; 18.46 | — |
| SECONDARY Hamilton Depression Rating Scale (HAM-D) Score |
7.77; 6.45; 11.56; 12.73; 12.33; 15.00 | — |
| SECONDARY Genetic Polymorphisms |
— | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00352885). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.