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Outcome Measures

Primary Outcomes (2)

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.
3-month follow up
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.
3-month follow up

Study Arms (2)

Assay Guided Group (AGG)

EXPERIMENTAL

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 - FolateGenetic: Cheek SwabOther: Self-report surveys

Treatment as Usual (TAU)

OTHER

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.

Interventions

Phlebotomy - FolateGenetic

This will be a blood draw performed at Visit 1 for Folate (one 7mL tube)

Assay Guided Group (AGG)Treatment as Usual (TAU)

Cheek SwabGenetic

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.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Study Design

Study Type

interventional

Phase

not applicable

Allocation

RANDOMIZED

Masking

NONE

Masking Details

No Masking

Purpose

SUPPORTIVE CARE

Intervention Model

PARALLEL

Model Details: 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.

Sponsor Type

OTHER

Responsible Party

PRINCIPAL INVESTIGATOR

PI Title

Principal Investigator

McLean and Genomind Prospective Study

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Study Arms (2)

Assay Guided Group (AGG)

Treatment as Usual (TAU)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Study Arms (2)

Assay Guided Group (AGG)

Treatment as Usual (TAU)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations