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Pharmacogenomics

Pharmacogenomic-Guided Antidepressant Therapy for Depression in Cancer Patients

N/A
Waitlist Available
Led By James K Hicks, PharmD, PhD
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be 18 years of age or older
Be older than 18 years old
Must not have
Patients not diagnosed with cancer
History of liver or allogenic stem cell transplant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 12, month 12
Awards & highlights

Summary

This trial will compare the effects of DNA-guided choice of antidepressant therapy versus clinical management alone in cancer patients.

Who is the study for?
This trial is for adult cancer patients who are experiencing depression or anxiety, with a score over 5 on a 10-point scale. They must have normal liver and kidney function tests, be able to fill out questionnaires, and not be pregnant. Those with cognitive impairments like dementia or psychological conditions such as schizophrenia are excluded.
What is being tested?
The study compares two approaches: one where antidepressant therapy is guided by the patient's DNA information versus standard clinical management without genetic guidance. The impact on depressive and anxiety symptoms, as well as quality of life will be measured.
What are the potential side effects?
While specific side effects aren't listed here, antidepressants can commonly cause nausea, sleep disturbances, fatigue, dry mouth, blurred vision, constipation and sometimes more serious risks depending on the individual's health status.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not been diagnosed with cancer.
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I have had a liver or stem cell transplant.
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I do not have cognitive or severe psychological impairments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 12, month 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 12, month 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in anxious symptoms from baseline, as measured by the Hospital Anxiety and Depression Scale (HADS)
Change in depressive symptoms from baseline, as measured by the Hospital Anxiety and Depression Scale (HADS)
Secondary study objectives
Quality of Life as measured by Functional Assessment of Cancer Therapy-General (FACT-G) Scale

Trial Design

2Treatment groups
Active Control
Group I: DNA-guided choice of therapyActive Control1 Intervention
DNA-guided choice of antidepressant therapy
Group II: Clinical managementActive Control2 Interventions
Clinical management

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
558 Previous Clinical Trials
144,441 Total Patients Enrolled
James K Hicks, PharmD, PhDPrincipal InvestigatorH. Lee Moffitt Cancer Center and Research Institute

Media Library

Pharmacogenomic-Guided Antidepressant Drug Prescribing (Pharmacogenomics) Clinical Trial Eligibility Overview. Trial Name: NCT03674138 — N/A
Depression Research Study Groups: DNA-guided choice of therapy, Clinical management
Depression Clinical Trial 2023: Pharmacogenomic-Guided Antidepressant Drug Prescribing Highlights & Side Effects. Trial Name: NCT03674138 — N/A
Pharmacogenomic-Guided Antidepressant Drug Prescribing (Pharmacogenomics) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03674138 — N/A
~14 spots leftby Sep 2025
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