McLean and Genomind Prospective Study

NCT03113890 | Completed

• 1 other identifier: 2017P000380
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder; PTSD

Keywords

pharmacogenetic testing; genomic; assay; PTSD; pharmacodynamic; pharmacokinetic; psychiatric disorders

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 - Folate; Genetic: Cheek Swab; Other: 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.

Genetic: Phlebotomy - Folate; Genetic: Cheek Swab; Other: Self-report surveys

Interventions

Phlebotomy - Folate GENETIC

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

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

Cheek Swab GENETIC

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.

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

Self-report surveys OTHER

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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
• Fluent English speakers

You may not qualify if:

• Involuntary hospitalization

Sponsors & Collaborators

• Mclean Hospital: lead
• Genomind, LLC: collaborator

Study Sites (1)

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Stress Disorders, Post-Traumatic; Mental Disorders

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Study Officials

• Kerry J Ressler, MD PhD

  Mclean Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No Masking
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

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.

Study Record Dates

• First Submitted: April 1, 2017
• First Posted: April 14, 2017
• Study Start: September 22, 2017
• Primary Completion: July 12, 2019
• Study Completion: July 31, 2020
• Last Updated: February 23, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)