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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 12, month 12
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 12, month 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 12, month 12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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
543 Previous Clinical Trials
135,383 Total Patients Enrolled
James K Hicks, PharmD, PhDPrincipal InvestigatorH. Lee Moffitt Cancer Center and Research Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not been diagnosed with cancer.I have had a liver or stem cell transplant.You are expected to live for at least 6 more months.I do not have cognitive or severe psychological impairments.I have been diagnosed with cancer.You have high levels of depression or anxiety, rated above 5 on a 10-point scale.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: DNA-guided choice of therapy
- Group 2: Clinical management
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this clinical trial still have availability for participants?
"Clinicaltrials.gov suggests that this research project is no longer searching for volunteers, having originally been published on September 12th 2018 and edited most recently on November 7th 2022. Despite this, there are still 2818 medical trials actively recruiting participants at the present moment."
Answered by AI
Who else is applying?
What state do they live in?
Florida
How old are they?
18 - 65
What site did they apply to?
H. Lee Moffitt Cancer Center and Research Institute
What portion of applicants met pre-screening criteria?
Met criteria
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