Psychiatric DisorderNCT03748355
Using Pharmacogenetics to Identify Patients With Polypharmacy at Risk of Medication Adverse Effects
A study testing Pharmacogentic Analysis in people with Psychiatric Disorder, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psychiatric Disorder
- What is being tested?
- Pharmacogentic Analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Oct 2018to 2 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
The Researchers are trying to learn more about how individuals break down and process medications based on their genes. The Researchers are doing this in order to assess the number of potential genotype-based drug interactions and side effects in patients with polypharmacy as well as to assess the number of potential individualized (based on the patient's genotype) drug interactions and side effects in these patients. After completing the OneOme genetic testing and relaying those results to the patients care team, the Researchers will then assess, at 30 days post-recommendations, whether the medication recommendations to reduce individualized drug interactions and adverse effects were followed, and (2) whether the adverse effects decrease compared to admission.
Patients will be recruited from the inpatient units listed in the inclusion criteria and, upon admission, each patient will complete a 24 item questionnaire measuring medication side effects, have a review of their medications for potential drug-drug and drug-genotype interactions (classified as low, medium or high risk), and then undergo the buccal swab to collect the DNA cells which will then be sent to OneOme for analysis. When the results are available, the study investigators will review the medications again for potential drug-drug and drug-genotype interactions and then communicate to the patients clinical team those results and whether medication changes are recommended to minimize the drug-drug and drug-genotype interactions.
Thirty days after the recommendations are communicated to the patient's clinical team, the patient will be contacted by phone. During this phone call, the following information will be obtained:
- The patient's current medication list.
- The patient's 24 item questionnaire measuring medication side effects.
- The patient's one item self rating of improvement Once this phone call is completed, the research team will determine whether the medication recommendations were followed by the patient's clinical team, whether the adverse effects decreased compared to hospital admission, and whether the patient reported improvement.
- Conditions
- Psychiatric Disorder
- Being tested
- Pharmacogentic Analysis
- Keywords
- Polypharmacy
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacogentic AnalysisGenetic
Also called OneOme Pharmacogentic Analysis
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.
| Study group | Role | What they receive |
|---|---|---|
| Pharmacogenetic Analysis | Other | A pharmacogenetic analysis will be completed for each participant upon inclusion into the study Receives: Genetic: Pharmacogentic Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of Potential Drug Interactions
Reduction of potential drug interactions risk measured by the numbers in low, medium and high categories.
Measured: 30 days
Secondary outcomes (1)
Reduction of Side Effects
Reduction of side effects as measured by side effects rating scale. Improvement of patient's self-assessment via the questionnaire item.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2018
- Study start14 Oct 2018
- Primary completion2 Jan 2020
- Study completion2 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychiatric DisorderStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simon Kung, Mayo Clinic
- Investigators
- Simon Kung, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03748355
- Sponsor's protocol ID
- 18-006182
- Status last verified
- Mar 2020
- First submitted
- 18 Nov 2018
- Last updated
- 11 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Pharmacogenetics to Identify Patients With Polypharmacy at Risk of Medication Adverse Effects
- ClinicalTrials.gov ID
- NCT03748355
- Acronym / sponsor ID
- 18-006182
- Conditions
- Psychiatric Disorder
- Keywords
- Polypharmacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 14 Oct 2018 (actual)
- Primary completion
- 2 Jan 2020 (actual)
- Study completion
- 2 Jan 2020 (actual)
- First posted
- 20 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The Researchers are trying to learn more about how individuals break down and process medications based on their genes. The Researchers are doing this in order to assess the number of potential genotype-based drug interactions and side effects in patients with polypharmacy as well as to assess the number of potential individualized (based on the patient's genotype) drug interactions and side effects in these patients. After completing the OneOme genetic testing and relaying those results to the patients care team, the Researchers will then assess, at 30 days post-recommendations, whether the medication recommendations to reduce individualized drug interactions and adverse effects were followed, and (2) whether the adverse effects decrease compared to admission.
Patients will be recruited from the inpatient units listed in the inclusion criteria and, upon admission, each patient will complete a 24 item questionnaire measuring medication side effects, have a review of their medications for potential drug-drug and drug-genotype interactions (classified as low, medium or high risk), and then undergo the buccal swab to collect the DNA cells which will then be sent to OneOme for analysis. When the results are available, the study investigators will review the medications again for potential drug-drug and drug-genotype interactions and then communicate to the patients clinical team those results and whether medication changes are recommended to minimize the drug-drug and drug-genotype interactions.
Thirty days after the recommendations are communicated to the patient's clinical team, the patient will be contacted by phone. During this phone call, the following information will be obtained:
- The patient's current medication list.
- The patient's 24 item questionnaire measuring medication side effects.
- The patient's one item self rating of improvement Once this phone call is completed, the research team will determine whether the medication recommendations were followed by the patient's clinical team, whether the adverse effects decreased compared to hospital admission, and whether the patient reported improvement.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pharmacogenetic Analysis | Other | Genetic: Pharmacogentic AnalysisA pharmacogenetic analysis will be completed for each participant upon inclusion into the study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmacogentic AnalysisAlso: OneOme Pharmacogentic AnalysisParticipant 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. | Genetic | Pharmacogenetic Analysis |
Primary outcome
Reduction of Potential Drug Interactions
Time frame: 30 days
Reduction of potential drug interactions risk measured by the numbers in low, medium and high categories.
1 secondary outcome
Reduction of Side Effects
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2020.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
Related trials for Psychiatric Disorder
RecruitingObservational study
SMART-r: Substance Monitoring and Active Relapse Tracking Repository
Alcoholism, Substance-Related Disorders
Recruiting
Inspiratory Muscle Training and Diaphragmatic Breathing in GAD
Generalized Anxiety Disorder (GAD)
RecruitingObservational study
Rigid Hymenal Ring as a Cause for Insertional Dyspareunia
Dyspareunia (Female)
Active, not recruitingObservational study
The Effect of Single Lung Ventilation Duration and Intraoperative Brain Oxygenation on Cognitive Function and Postoperative Pain in Geriatric Patients
Thoracic Anesthesia, Geriatric Anesthesia
Enrolling by invitationObservational study
Trajectory Study: Predicting Cardiometabolic Health in Adolescents and Young Adults Based on Childhood Fitness, Sleep, and Diet
Cardiometabolic Health
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simon Kung, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacogentic Analysis in people with Psychiatric Disorder, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of Potential Drug Interactions (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2020.