Overview

Pilot Study to Evaluate Individualized Choice of Antidepressants in Patients With Cancer

Status:
Completed
Trial end date:
2013-10-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Early Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
UNC Lineberger Comprehensive Cancer Center
Treatments:
Antidepressive Agents
Citalopram
Dexetimide
Mianserin
Mirtazapine
Criteria
Inclusion Criteria:

- 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

Exclusion Criteria:

- 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