Effectiveness of Escitalopram in Preventing or Reducing Depressive Symptoms in People Receiving Interleukin-2 Treatment

Completed · Phase 4 · Has a placebo group

Conditions studied: Depression

In brief

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.

Key facts

Study ID

NCT00352885

Run by

Emory University

People needed

20

Starts

2006-10-06

Expected to finish

2010-05-17

Last updated by the study team

2018-09-14

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosed with cancer and beginning Interleukin (IL)-2 treatment
• Willing to use an effective form of birth control throughout the study if sexually active

You may not qualify if…

• 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

Where it is running

• Winship Cancer Institute — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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