Major Depressive Disorder Clinical Trial
— NRROfficial title:
A Pilot Study to Evaluate Individualized Choice of Antidepressant in Patients With Cancer
Verified date | March 2017 |
Source | UNC Lineberger Comprehensive Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 21 |
Est. completion date | October 2013 |
Est. primary completion date | May 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of North Carolina Hospital | Chapel Hill | North Carolina |
Lead Sponsor | Collaborator |
---|---|
UNC Lineberger Comprehensive Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feasibility | To determine the feasibility of this pilot study to recruit subjects, as measured by the number of individuals enrolled per month, such that the goal of the study is met in a timely manner. | One year | |
Secondary | Depression Score | To assess the short-term (9 week) outcome of mirtazapine or citalopram in cancer patients with major depressive disorder based on mean improvement in depressive symptoms as measured by the Patient Health Questionnaire (PHQ-9) | 9 weeks |
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