Pilot Study to Evaluate Individualized Choice of Antidepressants in Patients With Cancer
Completed · Early Phase 1
Conditions studied: Major Depressive Disorder, Neoplasms
In brief
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.
Key facts
- Study ID
- NCT01725048
- Run by
- UNC Lineberger Comprehensive Cancer Center
- People needed
- 21
- Starts
- 2011-01-01
- Expected to finish
- 2013-10-01
- Last updated by the study team
- 2017-03-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of North Carolina Hospital — Chapel Hill, North Carolina, United States
Full record on ClinicalTrials.gov
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