Pharmacogenomic-Guided Antidepressant Drug Prescribing in Cancer Patients

NCT ID: NCT03674138

Last Updated: 2025-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-12

Study Completion Date

2024-10-27

Brief Summary

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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

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Conditions

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Depression Anxiety Generalized Anxiety Disorder Depressive Disorder Major Depressive Disorder Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants
Patients will be blinded to the genomic results for 12 weeks, with the 12 week time period starting at the time of antidepressant drug prescribing.

Study Groups

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DNA-guided choice of therapy

DNA-guided choice of antidepressant therapy

Group Type ACTIVE_COMPARATOR

DNA-guided choice of therapy

Intervention Type DIAGNOSTIC_TEST

Buccal swab for DNA genotyping to identify best antidepressant therapy

Clinical management

Clinical management

Group Type ACTIVE_COMPARATOR

DNA-guided choice of therapy

Intervention Type DIAGNOSTIC_TEST

Buccal swab for DNA genotyping to identify best antidepressant therapy

Clinical management

Intervention Type OTHER

Clinical management to identify best antidepressant therapy

Interventions

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DNA-guided choice of therapy

Buccal swab for DNA genotyping to identify best antidepressant therapy

Intervention Type DIAGNOSTIC_TEST

Clinical management

Clinical management to identify best antidepressant therapy

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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James K Hicks, PharmD, PhD

Role: PRINCIPAL_INVESTIGATOR

H. Lee Moffitt Cancer Center and Research Institute

Locations

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H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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MCC-19578

Identifier Type: -

Identifier Source: org_study_id