Effectiveness of Escitalopram in Preventing or Reducing Depressive Symptoms in People Receiving Interleukin-2 Treatment
Condition: Depression
MeSH terms: Depression
Intervention: Escitalopram; Placebo; IL-2
Intervention description: Participants will begin medication approximately 2 weeks before their first scheduled IL-2 treatment. The dosage for the first week will be 10 mg per day. If 10 mg is well tolerated by the participant, the dosage will be increased to 20 mg per day. The dosage for the remainder of the study will be 20 mg per day.; Participants will begin the placebo approximately 2 weeks before their first scheduled IL-2 treatment. The dosage for the first week will be 1 pill per day, if 1 pill is well tolerated by the participant the dosage will be increased to 2 pills per day. Two pills per day will be the dosage for the reminder of the study.; IL-2 is a 12-week treatment regimen with intravenous (IV) IL-2. There will be one cycle every 3 weeks for a total of four cycles. One cycle is 720,000 units/kg every 8 hours for 5 days.
Intervention MeSH terms: Escitalopram
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Cancer; IL-2 therapy; Antidepressant; Immune system; Neuroendocrine response

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.
    

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