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IL-2 Neuropsychiatric Symptoms: Mechanism and Prevention

Phase 4
18 Years
75 Years
Open (Enrolling)

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Trial Information

IL-2 Neuropsychiatric Symptoms: Mechanism and Prevention

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.

Inclusion Criteria:

- Diagnosed with cancer and beginning IL-2 treatment

- Willing to use an effective form of birth control throughout the study if sexually

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 DSM-IV criteria for substance abuse or dependence within 3 months of study

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

Number of IL-2 treatments tolerated

Outcome Time Frame:

Measured over 5 months of treatment

Safety Issue:


Principal Investigator

Dominique L. Musselman, MD,MS

Investigator Role:

Principal Investigator

Investigator Affiliation:

Emory University


United States: Federal Government

Study ID:

R01 MH071580



Start Date:

January 2006

Completion Date:

November 2010

Related Keywords:

  • Depression
  • Cancer
  • IL-2 therapy
  • Antidepressant
  • Immune system
  • Neuroendocrine response
  • Depression
  • Depressive Disorder



Winship Cancer Institute Atlanta, Georgia  30322