Pharmacogenomic-Guided Antidepressant Drug Prescribing in Cancer Patients

Not Applicable

Completed

• Conditions: Anxiety; Generalized Anxiety Disorder; Depressive Disorder; Major Depressive Disorder; Cancer; Depression
• Interventions: Diagnostic Test: DNA-guided choice of therapy; Other: Clinical management

• Registration Number: NCT03674138
• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-12
• Study First Submitted: 2018-09-12
• Study First Submitted QC: 2018-09-13
• Study First Posted: 2018-09-17
• Primary Completion: 2021-09-03
• Study Completion: 2024-10-27
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-10
• Last Update Posted: 2025-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
DNA-guided choice of therapy	DNA-guided choice of therapy	DNA-guided choice of antidepressant therapy
Clinical management	Clinical management	Clinical management
Clinical management	DNA-guided choice of therapy	Clinical management

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

H. Lee Moffitt Cancer Center and Research Institute; 🇺🇸 Tampa, Florida, United States