This is a pilot study to test the hypothesis that the antidepressants mirtazapine and
citalopram are effective treatment for major depressive disorder (MDD) in cancer patients.
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Locations near you
Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Full eligibility criteria for NCT01725048
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
Diagnosed with a malignancy
Informed consent obtained and signed
Greater than or equal to 18 years of age
Life expectancy determined to be greater than or equal to 6 months
Diagnosed with Major Depressive Disorder based on clinical examination and the DSM-IV-TR criteria
PHQ-9 depression assessment completed by subject, with a score of 10 or greater
Able to take whole or crushed tablets by mouth or by feeding tube
Unable to complete self-report instruments due to illiteracy, neurologic illness, visual problems, inability to speak or read English, or other causes
Treatment with antidepressants or antipsychotics within the last 3 months
Psychotic or manic behavior
Active suicidal ideation or plan
Current illicit substance abuse
Severe renal impairment as defined by creatinine clearance of <15 milliliters/minute/1.73 meters squared (mL/min/m2)
Severe hepatic impairment as defined by Aspartate Aminotransferase (AST) or alanine aminotransferase (ALT) >5x the upper limit of normal, or a total bilirubin > 3.0 milliliters/deciliter (mL/dL)
History of congenital long QT syndrome
Clinically significant congestive heart failure or bradyarrhythmias
Treatment with a concomitant medication that is known to have a strong association with corrected QT interval (QTc) prolongation AND a QTc >460 for men or >470 for women. Applicable to the citalopram arm only
All locations for NCT01725048
United States (1)
University of North Carolina Hospital
Chapel Hill, North Carolina, United States, 27599
View full eligibility
Tris trial is registered with FDA with number: NCT01725048. The sponsor of the trial is UNC Lineberger Comprehensive Cancer Center and it is looking for 21 volunteers for the current phase.
Official trial title: A Pilot Study to Evaluate Individualized Choice of Antidepressant in Patients With Cancer
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