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McLean and Genomind Prospective Study (GPS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03113890
Recruitment Status : Unknown
Verified September 2017 by Kerry Ressler, Mclean Hospital.
Recruitment status was:  Recruiting
First Posted : April 14, 2017
Last Update Posted : September 27, 2017
Sponsor:
Collaborator:
Genomind, LLC
Information provided by (Responsible Party):
Kerry Ressler, Mclean Hospital

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.


Condition or disease Intervention/treatment Phase
Major Depressive Disorder PTSD Genetic: Phlebotomy - Folate Genetic: Cheek Swab Other: Self-report surveys Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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
Primary Purpose: Supportive Care
Official Title: McLean and Genomind Prospective Study of Pharmacogenetic Testing
Actual Study Start Date : September 22, 2017
Estimated Primary Completion Date : August 1, 2019
Estimated Study Completion Date : August 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Assay Guided Group (AGG)
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.
Genetic: Phlebotomy - Folate
This will be a blood draw performed at Visit 1 for Folate (one 7mL tube)

Genetic: Cheek Swab
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.

Other: Self-report surveys
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.

Treatment as Usual (TAU)
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.
Genetic: Phlebotomy - Folate
This will be a blood draw performed at Visit 1 for Folate (one 7mL tube)

Genetic: Cheek Swab
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.

Other: Self-report surveys
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 Measures :
  1. Does Inpatient Genetic Testing Improve Symptoms at Follow-up: [ Time Frame: 3-month follow up ]
    This aim will test if, by the 3-month follow-up, inpatient psychopharmacogenetic testing will reduce symptoms of depression and anxiety.

  2. Does Inpatient Genetic Testing Improve Readmission: [ Time Frame: 3-month follow up ]
    This aim will test if, by the 3-month follow-up, inpatient psychopharmacogenetic testing will reduce frequency of inpatient readmission.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03113890


Contacts
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Contact: Kerry J Ressler, MD PhD 617 855 4210 kressler@partners.org
Contact: Christopher King, EdM 617-855-4203 ck578@partners.org

Locations
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United States, Massachusetts
McLean Hospital Recruiting
Belmont, Massachusetts, United States, 02478
Contact: Kerry J Ressler, MD PhD    617-855-4210    kressler@partners.org   
Contact: Ying Cao, MD    617-855-3172    ycao9@partners.org   
Principal Investigator: Kerry J Ressler, MD PhD         
Sponsors and Collaborators
Mclean Hospital
Genomind, LLC
Investigators
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Principal Investigator: Kerry J Ressler, MD PhD Mclean Hospital
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Responsible Party: Kerry Ressler, Principal Investigator, Mclean Hospital
ClinicalTrials.gov Identifier: NCT03113890    
Other Study ID Numbers: 2017P000380
First Posted: April 14, 2017    Key Record Dates
Last Update Posted: September 27, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kerry Ressler, Mclean Hospital:
pharmacogenetic testing
genomic
assay
PTSD
pharmacodynamic
pharmacokinetic
psychiatric disorders
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders