Depression, Anxiety, Generalized Anxiety Disorder, Depressive Disorder, Major Depressive Disorder, Cancer
Conditions
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.
Interventions
DIAGNOSTIC_TESTDNA-guided choice of therapy
Buccal swab for DNA genotyping to identify best antidepressant therapy
OTHERClinical management
Clinical management to identify best antidepressant therapy
Sponsors
H. Lee Moffitt Cancer Center and Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Masking description
Patients will be blinded to the genomic results for 12 weeks, with the 12 week time period starting at the time of antidepressant drug prescribing.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in depressive symptoms from baseline, as measured by the Hospital Anxiety and Depression Scale (HADS) | 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) | 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
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life as measured by Functional Assessment of Cancer Therapy-General (FACT-G) Scale | 12 months | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJames K Hicks, PharmD, PhD
H. Lee Moffitt Cancer Center and Research Institute
Outcome results
None listed