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| Name | Class |
|---|---|
| Genomind, LLC | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Genecept Assay and G-DIG decision tool | Genetic | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Global Impression | Clinical Global Impression. Range is 1-6, with 1 = less symptomology and 6 = high symptomology. | Baseline and 12-weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Psychiatric Medications | Number of psychiatric medications prescribed to the patient. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Amanda E Wood, PhD. | VA Puget Sound Health Care System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Puget Sound Health Care System | Tacoma | Washington | 98493 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35075665 | Result | 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. |
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recruitment lasted from 10/04/2017 to 12/31/2018
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| ID | Title | Description |
|---|---|---|
| FG000 | Genecept Assay and G-DIG Decision Tool | Veterans 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 for side effects related to a medication prescribed for the mental health diagnosis. Genecept Assay and G-DIG decision tool: Participating providers review results of the Genecept Assay using a secure web-based program and utilize the G-DIG tool 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 21, 2018 |
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a cheek swab tissue sample for DNA collection will be obtained from each consented study participant in order to complete the pharmacogenomic testing; via the Genecept Assay testing results.
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| 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. | Change from baseline to 12-weeks |
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| NOT COMPLETED |
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Participants as described in data tables.
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| ID | Title | Description |
|---|---|---|
| BG000 | Genecept Assay and G-DIG Decision Tool | Veterans 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 for side effects related to a medication prescribed for the mental health diagnosis. Genecept Assay and G-DIG decision tool: Participating providers review results of the Genecept Assay using a secure web-based program and utilize the G-DIG tool 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 or removing medications will be determined by the provider. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
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| Age, Categorical | Count of Participants | Participants | No |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| CGI | Mean | Standard Deviation | units on a scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Clinical Global Impression | Clinical Global Impression. Range is 1-6, with 1 = less symptomology and 6 = high symptomology. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 12-weeks |
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| Secondary | Number of Psychiatric Medications | Number of psychiatric medications prescribed to the patient. | Posted | Mean | Standard Deviation | prescriptions | Change from baseline to 12-weeks |
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| Secondary | 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. | Posted | Mean | Standard Deviation | scores | Change from baseline to 12-weeks |
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| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | Change from baseline to 12-weeks |
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Baseline, 6-weeks, 12-weeks
This is a naturalistic study, side effects of medication treatment are an expected part of treatment as usual and will be handled by their provider as part of their regular clinical care. A brief measure of side effects will be collected by patient interview at baseline, 6-weeks, and 12-weeks. If the participant reveals an emergent mental or physical health issue they will be treated as per clinical guidelines at the VA.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Genecept Assay and G-DIG Decision Tool | Veterans 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 for side effects related to a medication prescribed for the mental health diagnosis. Genecept Assay and G-DIG decision tool: Participating providers review results of the Genecept Assay using a secure web-based program and utilize the G-DIG tool 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 or removing medications will be determined by the provider. | 0 | 53 | 0 | 53 | 0 | 53 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Amanda E. Wood; Clinical Research Psychologist, VA PSHCS | VA Puget Sound Health Care System | 253-583-1652 | 71652 | amanda.wood@va.gov |
| Jun 24, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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