Pharmacogenomic-Guided Antidepressant Drug Prescribing in Cancer Patients

Study Overview
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Brief Summary
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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.

Official Title
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Pharmacogenomic-Guided Antidepressant Drug Prescribing in Cancer Patients

Conditions
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Generalized Anxiety Disorder, Depressive Disorder, Depression, Anxiety, Major Depressive Disorder, Cancer

Intervention / Treatment
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* Diagnostic Test: DNA-guided choice of therapy
* Other: Clinical management


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: DNA-guided choice of therapy<br>DNA-guided choice of antidepressant therapy | Diagnostic Test: DNA-guided choice of therapy<br>* Buccal swab for DNA genotyping to identify best antidepressant therapy<br>|
| Active Comparator: Clinical management<br>Clinical management | Diagnostic Test: DNA-guided choice of therapy<br>* Buccal swab for DNA genotyping to identify best antidepressant therapy<br>Other: Clinical management<br>* Clinical management to identify best antidepressant therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in depressive symptoms from baseline, as measured by the Hospital Anxiety and Depression Scale (HADS) | The Hospital Anxiety and Depression scale can range from 0 to 42 (14 questions each on a 0-3 point scale). | Baseline, week 12, month 12 | 
| Change in anxious symptoms from baseline, as measured by the Hospital Anxiety and Depression Scale (HADS) | The Hospital Anxiety and Depression scale can range from 0 to 42 (14 questions each on a 0-3 point scale). | Baseline, week 12, month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life as measured by Functional Assessment of Cancer Therapy-General (FACT-G) Scale | Quality of Life as measured by Functional Assessment of Cancer Therapy-General (FACT-G) Scale. FACT-G is a quality of life questionnaire with values ranging from 0 (not at all) to 4 (very much). The categories of measure are physical, social/family, emotional and functional well-being. | 12 months |