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Clinical Trial 19578

Cancer Type: Multiple
Study Type: Supportive Care
NCT#: NCT03674138

Phase: N/A
Prinicipal Investigator:

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Study Title

Pharmacogenomic-Guided Antidepressant Drug Prescribing in Cancer Patients


The purpose of this research study is to find out if information about a patient's genetic makeup (DNA) will help doctors better manage depression and anxiety symptoms.


Aim 1: Compare self-reported symptoms of depression and anxiety between DNA-guided or clinical management alone antidepressant prescribing strategies in cancer patients. Aim 2: Determine the impact DNA-guided choice of antidepressant has on quality of life in cancer patients.




Inclusion Criteria

> Patients with a cancer diagnosis.

  • Be 18 years of age or older
  • Patients who rate depression AND anxiety > 5 based on a 10 point scale
  • Patients expected to live greater than 6 months
  • Serum bilirubin and creatinine > AST and ALT > Be willing and able to provide written informed consent
  • Be able to complete self-assessment questionnaires

  • Exclusion Criteria

    > Patients not diagnosed with cancer

  • Antidepressant prescribing performed by a non-Moffitt psychiatrist after enrollment onto the clinical trial.
  • Known Pregnancy
  • History of liver or allogenic stem cell transplant
  • Patients with a known cognitive impairment (e.g., delirium, dementia, etc.) or psychological impairment (e.g., schizophrenia, bipolar disease, etc.) other than depressive and anxiety symptoms
  • Patients enrolled on the clinical trial who are not prescribed an antidepressant by a Moffitt psychiatrist within 3 months will be removed from the study. Patients who are taking an antidepressant are allowed to enroll onto the study. However, a Moffitt psychiatrist must make a change to antidepressant therapy (e.g., switching to another antidepressant) after enrollment onto the study. If a patient is already on an antidepressant but not prescribed a different antidepressant within 3 months of enrollment, then the patient will be removed from the study. Genomic test results obtained as part of this clinical trial will be shared with the patient at time of removal from the clinical trial, if not previously disclosed. In the event that a genomic assay fails, the patient and/or psychiatrist will be consulted to determine if additional genomic testing is feasible or if removal from the study is warranted.

  • If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.