Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase IV	Supportive care, Treatment	Active	18 to 75	NIMH	R01 MH071580 DATR A3-NSS, NCT00352885

Trial Description

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.

Further Study Information

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.

Eligibility Criteria

Inclusion Criteria:

• Diagnosed with cancer and beginning 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 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

Trial Contact Information

Trial Lead Organizations/Sponsors

National Institute of Mental Health

Dominique L. Musselman, MD,MS

Principal Investigator

David Lawson, MD

Study Chair

Andrew Miller, MD

Study Chair

Erica C. Bruce, MPH		Ph: 404-712-9614
		Email: ecbruce@emory.edu

Carol Hill, RN		Ph: 404-778-4907
		Email: carol.hill@emoryhealthcare.org

U.S.A.
Georgia
	Atlanta
	Winship Cancer Institute of Emory University

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00352885
Information obtained from ClinicalTrials.gov on March 18, 2009