Pharmacogenomic-Guided Antidepressant Drug Prescribing in Cancer Patients

H. Lee Moffitt Cancer Center and Research Institute99 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Depression Anxiety Generalized Anxiety Disorder Depressive Disorder Major Depressive Disorder

Interventions

DNA-guided choice of therapyDIAGNOSTIC_TEST

Buccal swab for DNA genotyping to identify best antidepressant therapy

Clinical managementOTHER

Clinical management to identify best antidepressant therapy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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).

Time frame: 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).

Time frame: Baseline, week 12, month 12

Secondary Outcomes

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.

Time frame: 12 months