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

NCT01725048 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2017-03-13

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Mirtazapine

7.5mg by mouth once a day at night. If subject has not had a 50% or greater reduction in the PHQ-9 depression assessment score, and if the subject is not experiencing unacceptable adverse effects, then the dose may be escalated first to 15mg by mouth every night and then to 30mg by mouth every night.

DRUG

Citalopram

Citalopram 10mg by mouth once daily. If the subject has not had a 50% or greater reduction in PHQ-9 depression assessment score, and if the subject is not experiencing unacceptable side effects, then the dose may be escalated first to 20mg by mouth every day and then to 40mg by mouth once a day.

Sponsors & Collaborators

  • UNC Lineberger Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Eliza Park, MD · University of North Carolina

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2012-05-31
Completion
2013-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01725048 on ClinicalTrials.gov