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McLean and Genomind Prospective Study (GPS)

Primary Purpose

Major Depressive Disorder, PTSD

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Phlebotomy - Folate
Cheek Swab
Self-report surveys
Sponsored by
Mclean Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Major Depressive Disorder focused on measuring pharmacogenetic testing, genomic, assay, PTSD, pharmacodynamic, pharmacokinetic, psychiatric disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Inpatients admitted to the Short Term Unit at Mclean Ability to understand and sign informed consent. These patients cover a transdiagnostic range of severe depression, anxiety, and PTSD.
  • Both genders, all ethnic backgrounds, age 18 or older
  • Fluent English speakers

Exclusion Criteria:

  • Involuntary hospitalization

Sites / Locations

  • McLean Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Assay Guided Group (AGG)

Treatment as Usual (TAU)

Arm Description

These patients will undergo a cheek swab to collect DNA for the Genecept assay. Study doctors will receive the Genecept report prior to patient discharge and use it to guide psychoeducation and medication management.

Thus this group will serve as the control group for the outcomes related to Genecept-guided decision making. These patients will undergo a cheek swab to collect DNA for the Genecept assay. Study doctors will receive the Genecept report at the 12-week follow up visit (12 weeks after patient discharge) and will use it to guide psychoeducation. The Study Doctors will not receive the report during the patient's inpatient stay (treatment as usual, TAU). Clinicians will receive the assay report for patients in the treatment-as-usual group at the 3-month followup period.

Outcomes

Primary Outcome Measures

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.
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 Outcome Measures

Full Information

First Posted
April 1, 2017
Last Updated
February 22, 2021
Sponsor
Mclean Hospital
Collaborators
Genomind, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT03113890
Brief Title
McLean and Genomind Prospective Study
Acronym
GPS
Official Title
McLean and Genomind Prospective Study of Pharmacogenetic Testing
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
September 22, 2017 (Actual)
Primary Completion Date
July 12, 2019 (Actual)
Study Completion Date
July 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mclean Hospital
Collaborators
Genomind, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 saliva/undergo 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 patient's 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 U.S., mental health disorders including MDD and PTSD account for 6.2% of the nation's 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 (STAR*D) study, only 37% achieved remission with first-line therapy with a selective serotonin reuptake inhibitor (SSRI), whereas 16.3% 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 Genomind's 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 saliva/undergo 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 patient's 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder, PTSD
Keywords
pharmacogenetic testing, genomic, assay, PTSD, pharmacodynamic, pharmacokinetic, psychiatric disorders

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The investigators will enroll 200 inpatient subjects over 2 years who will donate saliva/undergo a cheek swab to collect DNA for the Genecept assay. For 100 patients in the assay-guided group (AGG), study doctors 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 patient's inpatient stay (treatment as usual, TAU). Study Doctors 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.
Masking
None (Open Label)
Masking Description
No Masking
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Assay Guided Group (AGG)
Arm Type
Experimental
Arm Description
These patients will undergo a cheek swab to collect DNA for the Genecept assay. Study doctors will receive the Genecept report prior to patient discharge and use it to guide psychoeducation and medication management.
Arm Title
Treatment as Usual (TAU)
Arm Type
Other
Arm Description
Thus this group will serve as the control group for the outcomes related to Genecept-guided decision making. These patients will undergo a cheek swab to collect DNA for the Genecept assay. Study doctors will receive the Genecept report at the 12-week follow up visit (12 weeks after patient discharge) and will use it to guide psychoeducation. The Study Doctors will not receive the report during the patient's inpatient stay (treatment as usual, TAU). Clinicians will receive the assay report for patients in the treatment-as-usual group at the 3-month followup period.
Intervention Type
Genetic
Intervention Name(s)
Phlebotomy - Folate
Intervention Description
This will be a blood draw performed at Visit 1 for Folate (one 7mL tube)
Intervention Type
Genetic
Intervention Name(s)
Cheek Swab
Intervention Description
Participants will undergo a cheek swab to then be analyzed using the Genecept Assay created by Genomind, Inc. This will occur once during Visit 1.
Intervention Type
Other
Intervention Name(s)
Self-report surveys
Intervention Description
At visit 1 and at visit 3 and 4, participants will be asked to complete self report diagnostic surveys and surveys related to the objective aims of the study.
Primary Outcome Measure Information:
Title
Does Inpatient Genetic Testing Improve Symptoms at Follow-up:
Description
This aim will test if, by the 3-month follow-up, inpatient psychopharmacogenetic testing will reduce symptoms of depression and anxiety.
Time Frame
3-month follow up
Title
Does Inpatient Genetic Testing Improve Readmission:
Description
This aim will test if, by the 3-month follow-up, inpatient psychopharmacogenetic testing will reduce frequency of inpatient readmission.
Time Frame
3-month follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Inpatients admitted to the Short Term Unit at Mclean Ability to understand and sign informed consent. These patients cover a transdiagnostic range of severe depression, anxiety, and PTSD. Both genders, all ethnic backgrounds, age 18 or older Fluent English speakers Exclusion Criteria: Involuntary hospitalization
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kerry J Ressler, MD PhD
Organizational Affiliation
Mclean Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
McLean Hospital
City
Belmont
State/Province
Massachusetts
ZIP/Postal Code
02478
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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McLean and Genomind Prospective Study

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