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.

Study Overview

• Status: Active, not recruiting
• Conditions: Depressive Disorder; Depression; Cancer; Generalized Anxiety Disorder; Anxiety; Major Depressive Disorder
• Intervention / Treatment: Diagnostic test: DNA-guided choice of therapy; Other: Clinical management

• Study Type: Interventional
• Enrollment (Actual): 99
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33612
      • H. Lee Moffitt Cancer Center and Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: DNA-guided choice of therapy; DNA-guided choice of antidepressant therapy	Diagnostic test: DNA-guided choice of therapy; Buccal swab for DNA genotyping to identify best antidepressant therapy
Active Comparator: Clinical management	Diagnostic test: DNA-guided choice of therapy; Buccal swab for DNA genotyping to identify best antidepressant therapy; Other: Clinical management; Clinical management to identify best antidepressant therapy

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Investigators: Principal Investigator: James K Hicks, PharmD, PhD, H. Lee Moffitt Cancer Center and Research Institute

Publications and helpful links

Helpful Links

• Moffitt Cancer Center Clinical Trials Website

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2018
• Primary Completion (Actual): September 3, 2021
• Study Completion (Estimated): October 2, 2024

Study Registration Dates

• First Submitted: September 12, 2018
• First Submitted That Met QC Criteria: September 13, 2018
• First Posted (Actual): September 17, 2018

Study Record Updates

• Last Update Posted (Estimated): January 11, 2024
• Last Update Submitted That Met QC Criteria: January 10, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Anxiety Disorders; Depressive Disorder, Major
• Other Study ID Numbers: MCC-19578

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes