Using Pharmacogenetics to Identify Patients With Polypharmacy at Risk of Medication Adverse Effects

NCT03748355 | Completed

• 1 other identifier: 18-006182
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The Researchers are trying to learn more about how individuals break down and process medications based on their genes. The Researchers want to find out whether subjects will have fewer side effects if they take different medications based on their pharmacogenomics profile.

Conditions

Psychiatric Disorder

Keywords

Polypharmacy

Outcome Measures

Primary Outcomes (1)

• Reduction of Potential Drug Interactions

  Reduction of potential drug interactions risk measured by the numbers in low, medium and high categories.

  30 days

Secondary Outcomes (1)

• Reduction of Side Effects

  30 days

Study Arms (1)

Pharmacogenetic Analysis

OTHER

A pharmacogenetic analysis will be completed for each participant upon inclusion into the study

Genetic: Pharmacogentic Analysis

Interventions

Pharmacogentic Analysis GENETIC

Participant will complete a buccal swab and it will be sent off to OneOme for analysis. When the results are available, the study investigators will review the medications for potential drug-drug and drug-genotype interactions. The risk for interactions will be classified as low, medium or high. The investigators will then communicate to the clinical team taking care of the patient these results and whether medication changes are recommended to minimize the drug-drug and drug-genotype interactions.

Also known as: OneOme Pharmacogentic Analysis

Pharmacogenetic Analysis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages 18 and older
• Hospitalized on Generose 2E (Acute Care Psychiatry), 3E (Medical and Geriatric Psychiatry), or 3W (Mood Disorders Unit).
• A voluntary patient
• Having 5 or more medications (scheduled or as needed) on their medication list.
• Ability to give informed consent

You may not qualify if:

• Patient with cognitive impairments such as moderate to severe dementia.
• Patients who do not communicate in English or cannot comprehend the rating scales used.
• Patients who have had pharmacogenetics testing performed within the previous 5 years.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Mental Disorders

Study Officials

• Simon Kung, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 18, 2018
• First Posted: November 20, 2018
• Study Start: October 14, 2018
• Primary Completion: January 2, 2020
• Study Completion: January 2, 2020
• Last Updated: March 11, 2020

Record last verified: 2020-03

Locations

US (1)