Pharmacogenomic-Guided Antidepressant Drug Prescribing in Cancer Patients

Depression Clinical Trial

Official title:

Pharmacogenomic-Guided Antidepressant Drug Prescribing in Cancer Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03674138
• Other study ID #: MCC-19578
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 12, 2018
• Est. completion date: October 2, 2024

Study information

• Verified date: January 2024
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 99
• Est. completion date: October 2, 2024
• Est. primary completion date: September 3, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Cancer
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Generalized Anxiety Disorder
• Major Depressive Disorder

Intervention

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

Locations

Country	Name	City	State
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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

External Links

•   Moffitt Cancer Center Clinical Trials Website