Pharmacogenetic Testing
Conditions
Keywords
polypharmacy, drug interactions, DNA testing, mental health diagnosis, drug side effects, presciption treatment plans, mental health medication treatment plans
Brief 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. 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.
Interventions
GENETICGenecept Assay and G-DIG decision tool
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.
Sponsors
Genomind, LLC
Seattle Institute for Biomedical and Clinical Research
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. 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 2. 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 3. 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. 4. Between the ages of 18-75.
Exclusion criteria
1. 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. 2. Current/active diagnosis of severe alcohol or drug use disorder 3. Serious medical or mental health symptoms requiring immediate stabilization and/or hospitalization 4. Impaired decision making capacity that in the clinical judgment of their provider would affect their ability to provide informed consent 5. Self-identification as being current pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Global Impression | Baseline and 12-weeks | Clinical Global Impression. Range is 1-6, with 1 = less symptomology and 6 = high symptomology. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Psychiatric Medications | Change from baseline to 12-weeks | Number of psychiatric medications prescribed to the patient. |
| Patient Health Questionnaire-9 (PHQ-9) | Change from baseline to 12-weeks | Patient Health Questionnaire-9 is a scale of depression, scores range from 0-27, with 0 representing less depression and 27 representing more depression. |
| Generalized Anxiety Scale-7 (GAD-7) | Change from baseline to 12-weeks | Generalized Anxiety Scale-7 is a measure of anxiety, scores range from 0-21, with 0 representing less anxiety and 7 representing more anxiety. |
Countries
United States
Participant flow
Recruitment details
recruitment lasted from 10/04/2017 to 12/31/2018
Participants by arm
| Arm | Count |
|---|---|
| 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. | 53 |
| Total | 53 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 4 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Genecept Assay and G-DIG Decision Tool |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 12 Participants |
| Age, Categorical Between 18 and 65 years | 41 Participants |
| CGI | 4.07 units on a scale STANDARD_DEVIATION 0.62 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 48 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 7 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 36 Participants |
| Region of Enrollment United States | 53 Participants |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 53 |
| other Total, other adverse events | 0 / 53 |
| serious Total, serious adverse events | 0 / 53 |
Outcome results
Primary
Clinical Global Impression
Clinical Global Impression. Range is 1-6, with 1 = less symptomology and 6 = high symptomology.
Time frame: Baseline and 12-weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Genecept Assay and G-DIG Decision Tool | Clinical Global Impression | CGI at 12-weeks | 3.96 units on a scale | Standard Deviation 0.59 |
| Genecept Assay and G-DIG Decision Tool | Clinical Global Impression | CGI at baseline | 4.07 units on a scale | Standard Deviation 0.62 |
p-value: <0.05t-test, 2 sided
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.
Time frame: Change from baseline to 12-weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Genecept Assay and G-DIG Decision Tool | Generalized Anxiety Scale-7 (GAD-7) | GAD-7 at baseline | 13.60 units on a scale | Standard Deviation 5.53 |
| Genecept Assay and G-DIG Decision Tool | Generalized Anxiety Scale-7 (GAD-7) | GAD-7 at 12-weeks | 12.02 units on a scale | Standard Deviation 5.9 |
p-value: <0.05ANOVA
Secondary
Number of Psychiatric Medications
Number of psychiatric medications prescribed to the patient.
Time frame: Change from baseline to 12-weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Genecept Assay and G-DIG Decision Tool | Number of Psychiatric Medications | Psychiatric meds at baseline | 3.85 prescriptions | Standard Deviation 1.41 |
| Genecept Assay and G-DIG Decision Tool | Number of Psychiatric Medications | Psychiatric meds at 12-weeks | 3.70 prescriptions | Standard Deviation 1.37 |
p-value: <0.05t-test, 2 sided
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.
Time frame: Change from baseline to 12-weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Genecept Assay and G-DIG Decision Tool | Patient Health Questionnaire-9 (PHQ-9) | PHQ-9 at 12-weeks | 13.43 scores | Standard Deviation 6.39 |
| Genecept Assay and G-DIG Decision Tool | Patient Health Questionnaire-9 (PHQ-9) | PHQ-9 at baseline | 15.81 scores | Standard Deviation 5.68 |
p-value: <0.05ANOVA