Status:
COMPLETED
Effectiveness of Escitalopram in Preventing or Reducing Depressive Symptoms in People Receiving Interleukin-2 Treatment
Lead Sponsor:
Emory University
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Depression
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief 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 untr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 6 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 17 2010
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00352885
Start Date
October 6 2006
End Date
May 17 2010
Last Update
September 14 2018
Active Locations (1)
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1
Winship Cancer Institute
Atlanta, Georgia, United States, 30322