Pharmacogenetic TestingMedOPTNCT03468309
Medication Optimization Using Pharmacogenetic Testing and the G-DIG to Reduce Polypharmacy in a Mental Health Population
An observational study of Pharmacogenetic Testing, run by Seattle Institute for Biomedical and Clinical Research at 1 site in United States.
Trial summary
Use of polypharmacy has significantly increased over the past two decades, which has unproven clinical benefit and is associate with an increased the risk of adverse side effects. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pharmacogenetic Testing
- What is being tested?
- Genecept Assay and G-DIG decision tool
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2018to 17 Apr 2024
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The subject pool will be drawn from Veterans receiving care at VA Puget Sound Health Care System for mental health diagnosis between the ages of 18-75 who meet all of the inclusion criteria with no indicators to any of the exclusionary criteria.
Who may be able to join
- Currently receiving outpatient care for mental health diagnosis at VA Puget Sound Health Care System (VA PSHCS) and referred by sub-investigator on listed for study
- Currently experiencing a sub-optimal medication response as assessed by either continue symptoms or medication side effects; which in the opinion of their treating provider would indicate or warrant a change in medications
- Currently prescribed at least five medications; two being for a mental health diagnosis OR one mental health medication prescribed for mental health diagnosis and one for mediating side effects related to the medication prescribed for the mental health diagnosis.
- Between the ages of 18-75.
Who cannot join
- Any mental health or physical health diagnosis, which in the opinion of their treating prescriber would prevent them from being compliant on a medication regimen or being able to complete the study measures.
- Current/active diagnosis of severe alcohol or drug use disorder
- Serious medical or mental health symptoms requiring immediate stabilization and/or hospitalization
- Impaired decision making capacity that in the clinical judgment of their provider would affect their ability to provide informed consent
- Self-identification as being current pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Puget Sound Health Care System
Tacoma, Washington, 98493
About this study
Official title: Medication Optimization Using Pharmacogenetic Testing and the Genomind Drug Interaction Guide (G-DIG) to Reduce Polypharmacy in a Mental Health Population
Use of polypharmacy has significantly increased over the past two decades, which has unproven clinical benefit and is associate with an increased the risk of adverse side effects. Pharmacogenetic assays, such as the Genecept® Assay, have the purported benefit of being able to predict response(s) to specific medication based on genetic markers. Thus, this study is a 12-week open-label, naturalistic study of the provision of pharmacogenetic testing and a computerized decision tool for providers to determine the potential efficacy of the assay to reduce polypharmacy and improve patient outcomes.
Read the detailed description
Use of polypharmacy has significantly increased over the past two decades, which has unproven clinical benefit and increased the risk of drug-drug interactions and adverse side effects. Pharmacogenetic assays have the purported benefit of being able to predict response(s) to specific medication based on genetic markers. One such assay is the Genecept® Assay produced by Genomind, which detects 63 allele polymorphisms of 18 genes. In addition, Genomind has developed the Genomind Drug Interaction Guide (G-DIG), which examines drug-drug-gene interactions. This computerized decision tool for medication providers uses the genetic information from the Genecept® Assay to look at the current medications being utilized to determine if there are specific drug-drug interactions that may be relevant given the individual's specific genetic test results.
This is a 12-week open-label, naturalistic study of the provision of pharmacogenetic testing information to both providers and patients. Fifty Veterans within the VAPSHCS who are prescribed polypharmacy, as defined as five or more medications, with at least two prescribed for a mental health diagnosis, and have a sub-optimal treatment effect will be enrolled in this study. Participating subjects will sign informed consent and a sample will be obtained in order to complete the pharmacogenomic testing. Medication providers who are participating in this study will utilize the pharmacogenetic assay results along with the G-DIG tool to design an optimized medication regime. The overall global level of symptoms and other patient symptoms measures will be administered at baseline, 6-weeks, and 12-weeks. The provider's medication plans will be compared before and after the pharmacogenetic assay information is provided. Number of medications will be reviewed to determine any reduction in polypharmacy and healthcare costs. The clinical global improvement scale (CGI) and patient assessments, including measures of depression, anxiety, PTSD, insomnia, pain, drug and alcohol use, quality of life, side effects, and medication adherence will be administered at baseline, 6-weeks, and 12-weeks.
- Conditions
- Pharmacogenetic Testing
- Being tested
- Genecept Assay and G-DIG decision tool
- Keywords
- polypharmacy, drug interactions, DNA testing, mental health diagnosis, drug side effects, presciption treatment plans, mental health medication treatment plans
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genecept Assay and G-DIG decision toolGenetic
Participating providers will review results of the Genecept Assay using a secure web-based program and will utilize the G-DIG tool in order to determine the optimal medication regime for the patient, based on their individual genetic profile. Genomind will provide training to all investigators prior to the study start regarding the interpretation of the pharmacological assay and the use of the G-DIG tool. Genomind representatives will be available throughout the duration of the study for consultation regarding the interpretation and implementation of the testing results. All final decisions about changing dosage, adding medications, or removing medications will be determined by the provider.
| Study group | Role | What they receive |
|---|---|---|
| Genecept Assay and G-DIG decision tool | Veterans who have been prescribed 5 or more medications, with at least two being for a mental health diagnosis. Also allowable would be one medication for a mental health diagnosis and another medication for side effects related to a medication prescribed for the mental health diagnosis. Receives: Genetic: Genecept Assay and G-DIG decision tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Global Impression
Clinical Global Impression. Range is 1-6, with 1 = less symptomology and 6 = high symptomology.
Measured: Baseline and 12-weeks
Secondary outcomes (3)
Number of Psychiatric Medications
Number of psychiatric medications prescribed to the patient.
Measured: Change from baseline to 12-weeks
Patient Health Questionnaire-9 (PHQ-9)
Patient Health Questionnaire-9 is a scale of depression, scores range from 0-27, with 0 representing less depression and 27 representing more depression.
Measured: Change from baseline to 12-weeks
Generalized Anxiety Scale-7 (GAD-7)
Generalized Anxiety Scale-7 is a measure of anxiety, scores range from 0-21, with 0 representing less anxiety and 7 representing more anxiety.
Measured: Change from baseline to 12-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2018
- Study start1 Jan 2018
- Primary completion1 Apr 2019
- Study completion17 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pharmacogenetic TestingStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seattle Institute for Biomedical and Clinical Research
- Sponsor type
- University, hospital or other
- Collaborators
- Genomind, LLC
- Responsible party
- Sponsor
- Investigators
- Amanda E Wood, PhD., Principal investigator, VA Puget Sound Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03468309
- Sponsor's protocol ID
- 01600
- Acronym
- MedOPT
- Status last verified
- Feb 2023
- First submitted
- 16 Nov 2017
- Last updated
- 23 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wood AE, Agrawal D, Deem AP, Dupper Knoper TL, Merino RF, Molzof HE, Maus LE, Kim F, Lodin Z, Lim S. Medication Optimization Using Pharmacogenomic Testing in a Complex Mental Health Population Prescribed Psychiatric Polypharmacy. J Clin Pharmacol. 2022 Jul;62(7):898-904. doi: 10.1002/jcph.2032. Epub 2022 Mar 4.
PubMed 35075665
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medication Optimization Using Pharmacogenetic Testing and the Genomind Drug Interaction Guide (G-DIG) to Reduce Polypharmacy in a Mental Health Population
- ClinicalTrials.gov ID
- NCT03468309
- Acronym / sponsor ID
- MedOPT / 01600
- Conditions
- Pharmacogenetic Testing
- Keywords
- polypharmacy, drug interactions, DNA testing, mental health diagnosis, drug side effects, presciption treatment plans, mental health medication treatment plans
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Seattle Institute for Biomedical and Clinical ResearchUniversity, hospital or other
- Collaborators
- Genomind, LLC
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 17 Apr 2024 (actual)
- First posted
- 16 Mar 2018 (actual)
- Results
- Posted 28 Feb 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Use of polypharmacy has significantly increased over the past two decades, which has unproven clinical benefit and is associate with an increased the risk of adverse side effects. Pharmacogenetic assays, such as the Genecept® Assay, have the purported benefit of being able to predict response(s) to specific medication based on genetic markers. Thus, this study is a 12-week open-label, naturalistic study of the provision of pharmacogenetic testing and a computerized decision tool for providers to determine the potential efficacy of the assay to reduce polypharmacy and improve patient outcomes.
Detailed description
Use of polypharmacy has significantly increased over the past two decades, which has unproven clinical benefit and increased the risk of drug-drug interactions and adverse side effects. Pharmacogenetic assays have the purported benefit of being able to predict response(s) to specific medication based on genetic markers. One such assay is the Genecept® Assay produced by Genomind, which detects 63 allele polymorphisms of 18 genes. In addition, Genomind has developed the Genomind Drug Interaction Guide (G-DIG), which examines drug-drug-gene interactions. This computerized decision tool for medication providers uses the genetic information from the Genecept® Assay to look at the current medications being utilized to determine if there are specific drug-drug interactions that may be relevant given the individual's specific genetic test results.
This is a 12-week open-label, naturalistic study of the provision of pharmacogenetic testing information to both providers and patients. Fifty Veterans within the VAPSHCS who are prescribed polypharmacy, as defined as five or more medications, with at least two prescribed for a mental health diagnosis, and have a sub-optimal treatment effect will be enrolled in this study. Participating subjects will sign informed consent and a sample will be obtained in order to complete the pharmacogenomic testing. Medication providers who are participating in this study will utilize the pharmacogenetic assay results along with the G-DIG tool to design an optimized medication regime. The overall global level of symptoms and other patient symptoms measures will be administered at baseline, 6-weeks, and 12-weeks. The provider's medication plans will be compared before and after the pharmacogenetic assay information is provided. Number of medications will be reviewed to determine any reduction in polypharmacy and healthcare costs. The clinical global improvement scale (CGI) and patient assessments, including measures of depression, anxiety, PTSD, insomnia, pain, drug and alcohol use, quality of life, side effects, and medication adherence will be administered at baseline, 6-weeks, and 12-weeks.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Genecept Assay and G-DIG decision tool | – | Genetic: Genecept Assay and G-DIG decision toolVeterans who have been prescribed 5 or more medications, with at least two being for a mental health diagnosis. Also allowable would be one medication for a mental health diagnosis and another medication for side effects related to a medication prescribed for the mental health diagnosis. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The subject pool will be drawn from Veterans receiving care at VA Puget Sound Health Care System for mental health diagnosis between the ages of 18-75 who meet all of the inclusion criteria with no indicators to any of the exclusionary criteria.
Key inclusion criteria (4 listed)
- Currently receiving outpatient care for mental health diagnosis at VA Puget Sound Health Care System (VA PSHCS) and referred by sub-investigator on listed for study
- Currently experiencing a sub-optimal medication response as assessed by either continue symptoms or medication side effects; which in the opinion of their treating provider would indicate or warrant a change in medications
- Currently prescribed at least five medications; two being for a mental health diagnosis OR one mental health medication prescribed for mental health diagnosis and one for mediating side effects related to the medication prescribed for the mental health diagnosis.
- Between the ages of 18-75.
Key exclusion criteria (5 listed)
- Any mental health or physical health diagnosis, which in the opinion of their treating prescriber would prevent them from being compliant on a medication regimen or being able to complete the study measures.
- Current/active diagnosis of severe alcohol or drug use disorder
- Serious medical or mental health symptoms requiring immediate stabilization and/or hospitalization
- Impaired decision making capacity that in the clinical judgment of their provider would affect their ability to provide informed consent
- Self-identification as being current pregnancy
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 |
|---|---|---|
| Genecept Assay and G-DIG decision toolParticipating providers will review results of the Genecept Assay using a secure web-based program and will utilize the G-DIG tool in order to determine the optimal medication regime for the patient, based on their individual genetic profile. Genomind will provide training to all investigators prior to the study start regarding the interpretation of the pharmacological assay and the use of the G-DIG tool. Genomind representatives will be available throughout the duration of the study for consultation regarding the interpretation and implementation of the testing results. All final decisions about changing dosage, adding medications, or removing medications will be determined by the provider. | Genetic | Genecept Assay and G-DIG decision tool |
Primary outcome
Clinical Global Impression
Time frame: Baseline and 12-weeks
Clinical Global Impression. Range is 1-6, with 1 = less symptomology and 6 = high symptomology.
3 secondary outcomes
Number of Psychiatric Medications
Time frame: Change from baseline to 12-weeks
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Change from baseline to 12-weeks
Generalized Anxiety Scale-7 (GAD-7)
Time frame: Change from baseline to 12-weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 35075665Wood AE, Agrawal D, Deem AP, Dupper Knoper TL, Merino RF, Molzof HE, Maus LE, Kim F, Lodin Z, Lim S. Medication Optimization Using Pharmacogenomic Testing in a Complex Mental Health Population Prescribed Psychiatric Polypharmacy. J Clin Pharmacol. 2022 Jul;62(7):898-904. doi: 10.1002/jcph.2032. Epub 2022 Mar 4.
- Individual participant dataSharing planned: No
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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.
Amanda E Wood, PhD. principal investigator
VA Puget Sound Health Care System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pharmacogenetic Testing, run by Seattle Institute for Biomedical and Clinical Research 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 4 inclusion and 5 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 23 Apr 2024. 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?
Yes. Results are posted in the registry (first posted 28 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Clinical Global Impression (time frame: Baseline and 12-weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03468309, which also lists 1 linked publication.
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 23 Apr 2024.