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McLean and Genomind Prospective Study

NCT03113890 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2021-02-23

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Genomind, LLC

    collaborator INDUSTRY

  • Mclean Hospital

    lead OTHER

Principal Investigators

  • Kerry J Ressler, MD PhD · Mclean Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-22
Primary Completion
2019-07-12
Completion
2020-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03113890 on ClinicalTrials.gov