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Completed

NCT Number: NCT03674138

Pharmacogenomic-Guided Antidepressant Drug Prescribing in Cancer Patients

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.

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Key information

Conditions

Depression Anxiety Anxiety Disorders Behavior Behavioral Symptoms Cancer Depressive Disorder Depressive Disorder, Major Generalized Anxiety Disorder Major Depressive Disorder Mental Disorders Mood Disorders Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DNA-guided choice of therapy

Diagnostic Test

Buccal swab for DNA genotyping to identify best antidepressant therapy

Clinical Management

Other

Clinical management to identify best antidepressant therapy

Primary outcomes

  1. 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).

  2. 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

  1. Quality of Life as measured by Functional Assessment of Cancer Therapy-General (FACT-G) Scale

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Registry information

Important dates

Study start
2018
Primary completion
2021
Study completion
2024
First posted
Sep 17, 2018
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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