Ignite Creation Date:
2024-05-06 @ 9:55 AM
Last Modification Date:
2024-10-26 @ 12:22 PM
Study NCT ID:
NCT03113890
Status:
COMPLETED
Last Update Posted:
2021-02-23
First Post:
2017-04-01
Brief Title:
McLean and Genomind Prospective Study
Sponsor:
Mclean Hospital
Organization:
Mclean Hospital
Study Overview
Official Title:
McLean and Genomind Prospective Study of Pharmacogenetic Testing
Status:
COMPLETED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GPS
Brief Summary:
This is a three month naturalistic prospective randomized open label study of pharmacogenetic testing and clinical outcomes in inpatients across diagnoses including Treatment Resistant Depression TRD with or without Post-Traumatic Stress Disorder PTSD recruiting from the Short Term Unit at McLean Hospital
Specifically the investigators will enroll 200 inpatient subjects over 2 years who will donate salivaundergo a cheek swab to collect DNA for the Genecept assay For 100 patients in the assay-guided group treating Clinicians will receive the Genecept report prior to patient discharge and use it to guide psychoeducation and medication management For the additional 100 inpatients treating clinicians will not receive the report during the patients inpatient stay treatment as usual Clinicians will receive the assay report for patients in the treatment-as-usual group at the 3-month followup period Thus this group will serve as the control group for the outcomes related to Genecept-guided decision making
Specifically the investigators will enroll 200 inpatient subjects over 2 years who will donate salivaundergo a cheek swab to collect DNA for the Genecept assay For 100 patients in the assay-guided group treating Clinicians will receive the Genecept report prior to patient discharge and use it to guide psychoeducation and medication management For the additional 100 inpatients treating clinicians will not receive the report during the patients inpatient stay treatment as usual Clinicians will receive the assay report for patients in the treatment-as-usual group at the 3-month followup period Thus this group will serve as the control group for the outcomes related to Genecept-guided decision making
Detailed Description:
Importance Relevance
Psychiatric disorders are etiologically complex and clinically heterogeneous which makes them challenging to diagnose and effectively treat Thus they pose a huge societal burden and involve substantial costs in human and financial terms Specifically in the US mental health disorders including MDD and PTSD account for 62 of the nations health care spending Major depressive disorder and schizophrenia are listed by the World Health Organization as being among the top 10 leading causes of years lost due to disability
The primary means of treating major mental illness remains psychotropic-based whether alone or in combination with psychotherapy Despite an ever-growing number of medication options however outcomes remain significantly suboptimal In the landmark Sequenced Treatment Alternatives to Relieve Depression STARD study only 37 achieved remission with first-line therapy with a selective serotonin reuptake inhibitor SSRI whereas 163 withdrew completely from treatment due to drug intolerance In the Clinical Antipsychotic Trails of Intervention Effectiveness CATIE over 74 eventually discontinued study medication either because of lack of efficacy or tolerability And in the Systematic Treatment Enhancement Program for Bipolar Disorder STEP-BD trial up to 75 patients experienced symptoms relapse over the course of follow-up
With the advent of the genomics revolution and precision and personalized medicine tailoring patients medication treatment to their individual pharmacokinetic and pharmacodynamic characteristics is being increasingly embraced by various fields of medicine Testing is currently available for cardiovascular cancer autoimmune infectious and psychiatric illnesses etc In fact over 140 US Food and Drug Administration FDA-approved drugs have pharmacogenomic-based guidelines at least 27 of these are psychotropics including Celexa for which the FDA specially recommend dose-reduction for P450 CYP2C19 poor metabolizers due to the risk of QT prolongation FDA 2014 Yet the vast majority of Celexa-prescribing clinicians are unaware of which of their patients are among the 3 of poor metabolizers or the 20 of the intermediate metabolizers who are also at increased risk
Genomind a Pennsylvania-based personalized medicine company provides genetic testing with the Genecept Assay that can help clinicians optimize treatment for their patients with mental illness This test is an alternative to the traditional trial and error approach to psychiatric drug prescribing which fails approximately 50 of the time
The Genecept Assay identifies patient-specific genetic markers that indicate which treatments are likely to work as intended be ineffective or cause adverse effects The assay is easily administered by a cheek swab test and analyzes variations in key genes that can inform treatment decisions The assay is used to guide treatment for a broad range of psychiatric conditions including depression anxiety obsessive-compulsive disorder OCD attention deficit hyperactivity disorder ADHD bipolar disorder post-traumatic stress disorder PTSD autism schizophrenia chronic pain and substance abuse Each test provides clinicians with an easy-to-read patient report and complimentary psychopharmacogenomic consultation with Genominds expert scientific staff including Physicians PhDs and PharmDs Additionally the assay has been shown in peer reviewed published studies to improve patient outcomes and reduce overall medical costs
Brief summary of procedures and recruitment
This is a six month naturalistic prospective randomized open label study of pharmacogenetic testing and clinical outcomes in inpatients across diagnoses including Treatment Resistant Depression TRD with or without Post-Traumatic Stress Disorder PTSD recruiting from the Short Term Unit at McLean Hospital
Specifically the investigators will enroll 200 inpatient subjects over 2 years who will donate salivaundergo a cheek swab to collect DNA for the Genecept assay For 100 patients in the assay-guided group treating Clinicians will receive the Genecept report prior to patient discharge and use it to guide psychoeducation and medication management For the additional 100 inpatients treating clinicians will not receive the report during the patients inpatient stay treatment as usual Clinicians will receive the assay report for patients in the treatment-as-usual group at the 3-month followup period Thus this group will serve as the control group for the outcomes related to Genecept-guided decision making
Primary Objectives
Objective 1 Does Inpatient Genetic Testing Improve Symptoms at Follow-up This aim will test if by the 3-month follow-up inpatient psychopharmacogenetic testing will reduce symptoms of depression and anxiety
Objective 2 Does Inpatient Genetic Testing Improve Readmission This aim will test if by the 3-month follow-up inpatient psychopharmacogenetic testing will reduce frequency of inpatient readmission
Secondary Objectives
Objective 3 Does Inpatient Genetic Testing Improve Discharge Measures This aim will test if by discharge inpatient psychopharmagogenetic testing enhances measures of patient satisfaction and symptom measurement
Objective 4 Does Inpatient Genetic Testing Improve Follow-up Measures This aim will test if by the time of 3-month and 6-month follow-up inpatient psychopharmacogenetic testing will increase measures of follow-up treatment compliance reduce time to stable medication regimen and suicide attempts reduce self-medication with substance of abuse
Objective 5 Does Inpatient Genetic Testing Improve Medication Management This aim will test if when examined retrospectively across the discharge and 3-month data and 6-month data inpatient psychopharmacogenetic testing will improve medication adherence reduce number of medication trials and reduce time-to-effective dose
Psychiatric disorders are etiologically complex and clinically heterogeneous which makes them challenging to diagnose and effectively treat Thus they pose a huge societal burden and involve substantial costs in human and financial terms Specifically in the US mental health disorders including MDD and PTSD account for 62 of the nations health care spending Major depressive disorder and schizophrenia are listed by the World Health Organization as being among the top 10 leading causes of years lost due to disability
The primary means of treating major mental illness remains psychotropic-based whether alone or in combination with psychotherapy Despite an ever-growing number of medication options however outcomes remain significantly suboptimal In the landmark Sequenced Treatment Alternatives to Relieve Depression STARD study only 37 achieved remission with first-line therapy with a selective serotonin reuptake inhibitor SSRI whereas 163 withdrew completely from treatment due to drug intolerance In the Clinical Antipsychotic Trails of Intervention Effectiveness CATIE over 74 eventually discontinued study medication either because of lack of efficacy or tolerability And in the Systematic Treatment Enhancement Program for Bipolar Disorder STEP-BD trial up to 75 patients experienced symptoms relapse over the course of follow-up
With the advent of the genomics revolution and precision and personalized medicine tailoring patients medication treatment to their individual pharmacokinetic and pharmacodynamic characteristics is being increasingly embraced by various fields of medicine Testing is currently available for cardiovascular cancer autoimmune infectious and psychiatric illnesses etc In fact over 140 US Food and Drug Administration FDA-approved drugs have pharmacogenomic-based guidelines at least 27 of these are psychotropics including Celexa for which the FDA specially recommend dose-reduction for P450 CYP2C19 poor metabolizers due to the risk of QT prolongation FDA 2014 Yet the vast majority of Celexa-prescribing clinicians are unaware of which of their patients are among the 3 of poor metabolizers or the 20 of the intermediate metabolizers who are also at increased risk
Genomind a Pennsylvania-based personalized medicine company provides genetic testing with the Genecept Assay that can help clinicians optimize treatment for their patients with mental illness This test is an alternative to the traditional trial and error approach to psychiatric drug prescribing which fails approximately 50 of the time
The Genecept Assay identifies patient-specific genetic markers that indicate which treatments are likely to work as intended be ineffective or cause adverse effects The assay is easily administered by a cheek swab test and analyzes variations in key genes that can inform treatment decisions The assay is used to guide treatment for a broad range of psychiatric conditions including depression anxiety obsessive-compulsive disorder OCD attention deficit hyperactivity disorder ADHD bipolar disorder post-traumatic stress disorder PTSD autism schizophrenia chronic pain and substance abuse Each test provides clinicians with an easy-to-read patient report and complimentary psychopharmacogenomic consultation with Genominds expert scientific staff including Physicians PhDs and PharmDs Additionally the assay has been shown in peer reviewed published studies to improve patient outcomes and reduce overall medical costs
Brief summary of procedures and recruitment
This is a six month naturalistic prospective randomized open label study of pharmacogenetic testing and clinical outcomes in inpatients across diagnoses including Treatment Resistant Depression TRD with or without Post-Traumatic Stress Disorder PTSD recruiting from the Short Term Unit at McLean Hospital
Specifically the investigators will enroll 200 inpatient subjects over 2 years who will donate salivaundergo a cheek swab to collect DNA for the Genecept assay For 100 patients in the assay-guided group treating Clinicians will receive the Genecept report prior to patient discharge and use it to guide psychoeducation and medication management For the additional 100 inpatients treating clinicians will not receive the report during the patients inpatient stay treatment as usual Clinicians will receive the assay report for patients in the treatment-as-usual group at the 3-month followup period Thus this group will serve as the control group for the outcomes related to Genecept-guided decision making
Primary Objectives
Objective 1 Does Inpatient Genetic Testing Improve Symptoms at Follow-up This aim will test if by the 3-month follow-up inpatient psychopharmacogenetic testing will reduce symptoms of depression and anxiety
Objective 2 Does Inpatient Genetic Testing Improve Readmission This aim will test if by the 3-month follow-up inpatient psychopharmacogenetic testing will reduce frequency of inpatient readmission
Secondary Objectives
Objective 3 Does Inpatient Genetic Testing Improve Discharge Measures This aim will test if by discharge inpatient psychopharmagogenetic testing enhances measures of patient satisfaction and symptom measurement
Objective 4 Does Inpatient Genetic Testing Improve Follow-up Measures This aim will test if by the time of 3-month and 6-month follow-up inpatient psychopharmacogenetic testing will increase measures of follow-up treatment compliance reduce time to stable medication regimen and suicide attempts reduce self-medication with substance of abuse
Objective 5 Does Inpatient Genetic Testing Improve Medication Management This aim will test if when examined retrospectively across the discharge and 3-month data and 6-month data inpatient psychopharmacogenetic testing will improve medication adherence reduce number of medication trials and reduce time-to-effective dose
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None