Pharmacogenomic-Guided Antidepressant Drug Prescribing in Cancer Patients
Overview
- Phase
- Not Applicable
- Intervention
- DNA-guided choice of therapy
- Conditions
- Depression
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Enrollment
- 99
- Locations
- 1
- Primary Endpoint
- Change in depressive symptoms from baseline, as measured by the Hospital Anxiety and Depression Scale (HADS)
- Status
- Completed
- Last Updated
- 2 months ago
Overview
Brief Summary
This is a prospective, randomized clinical trial to investigate the clinical impact of a preemptive pharmacogenomics strategy to guide antidepressant therapy in cancer patients. Those enrolled onto the clinical trial will be randomized to either DNA-guided choice of therapy or clinical management alone. Scores on self-reported measures of depressive and anxiety symptoms along with quality of life will be compared between cohorts.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with a cancer diagnosis
- •Be 18 years of age or older
- •Patients who rate depression or anxiety \> 5 based on a 10 point scale
- •Patients expected to live greater than 6 months
- •Serum bilirubin and creatinine \< 1.5x upper limit of normal
- •AST and ALT \< 3 times upper limit of normal
- •Willing and able to provide written informed consent
- •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.
Arms & Interventions
DNA-guided choice of therapy
DNA-guided choice of antidepressant therapy
Intervention: DNA-guided choice of therapy
Clinical management
Clinical management
Intervention: DNA-guided choice of therapy
Clinical management
Clinical management
Intervention: Clinical management
Outcomes
Primary Outcomes
Change in depressive symptoms from baseline, as measured by the Hospital Anxiety and Depression Scale (HADS)
Time Frame: Baseline, week 12, month 12
The Hospital Anxiety and Depression scale can range from 0 to 42 (14 questions each on a 0-3 point scale).
Change in anxious symptoms from baseline, as measured by the Hospital Anxiety and Depression Scale (HADS)
Time Frame: Baseline, week 12, month 12
The Hospital Anxiety and Depression scale can range from 0 to 42 (14 questions each on a 0-3 point scale).
Secondary Outcomes
- Quality of Life as measured by Functional Assessment of Cancer Therapy-General (FACT-G) Scale(12 months)