Effectiveness of Escitalopram in Preventing or Reducing Depressive Symptoms in People Receiving Interleukin-2 Treatment
Condition: Depression
MeSH terms: Depression
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      Melanoma is the most serious type of skin cancer, affecting nearly 54,000 people in the
      United States each year. Melanomas often develop in pre-existing moles or as new moles on the
      body. If left untreated, the cancerous cells can spread throughout the body. Fortunately,
      melanoma can be cured if a person is diagnosed and treated early. Typical treatments include
      surgery, amputation, chemotherapy, and immunotherapy. Interleukin-2 (IL-2) treatment, a type
      of immunotherapy, uses the body's immune system to slow or stop the spread of cancer cells to
      other parts of the body. However, IL-2 treatment is typically associated with severe side
      effects, including depression, fatigue, and difficulty thinking. This study will evaluate
      whether escitalopram, an antidepressant, can help improve treatment-related depressive
      symptoms, reduce stress hormone levels, and increase the number of treatment cycles among
      people with metastatic melanoma who are receiving IL-2 treatment.

      Participation in this double-blind study will last up to 18 weeks and will include 5 to 14
      study visits. Participants will complete four 1-week cycles of IL-2 treatment over a 12-week
      period. Two weeks prior to starting IL-2 treatment, participants will undergo a psychiatric
      interview; a computerized thinking test; questionnaires; and blood, urine, and saliva
      collection. Participants will also be randomly assigned to start receiving either
      escitalopram or placebo for the entire duration of the study. The dosage of escitalopram or
      placebo will vary depending on the symptom severity of each participant. Immediately prior to
      IL-2 treatment, participants will undergo preliminary IL-2 procedures, which will include a
      medical history review, physical exam, and blood collection. These same procedures will occur
      every day that the participant is in the hospital for IL-2 treatment. Participants will stay
      in the hospital when receiving all four IL-2 treatment cycles. During these hospital stays,
      participants will complete repeat questionnaires and computerized tasks. Blood collection
      will occur at selected times as well. A follow-up visit will occur 4 weeks after the final
      treatment dose of IL-2.
    

Intervention name(s): Escitalopram; Placebo; IL-2
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 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.
Other intervention name(s): Lexapro; Sugar pill
Intervention MeSH terms: Escitalopram
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Cancer; IL-2 therapy; Antidepressant; Immune system; Neuroendocrine response