Pharmacogenomic-Guided Antidepressant Drug Prescribing in Cancer Patients

H. Lee Moffitt Cancer Center and Research Institute

Status: Completed

Conditions: Major Depressive Disorder; Generalized Anxiety Disorder; Cancer; Depression; Anxiety; Depressive Disorder

Treatments: Diagnostic Test: DNA-guided choice of therapy; Other: Clinical management

Study type: Interventional

Funder types: Other

Identifiers

NCT03674138

MCC-19578

Details and patient eligibility

About

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.

Enrollment: 99 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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99 participants in 2 patient groups

DNA-guided choice of therapy

Active Comparator group

Description:

DNA-guided choice of antidepressant therapy

Treatment:

Diagnostic Test: DNA-guided choice of therapy

Clinical management

Active Comparator group

Description:

Clinical management

Treatment:

Other: Clinical management

Diagnostic Test: DNA-guided choice of therapy