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

• Status: Completed
• Trial end date: 2010-05-17
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emory University
• Collaborator: National Institute of Mental Health (NIMH)
• Treatments: Citalopram; Dexetimide; Interleukin-2

Criteria

Inclusion Criteria:

• 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 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 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