Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03113890
Other study ID # 2017P000380
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 22, 2017
Est. completion date July 31, 2020

Study information

Verified date February 2021
Source Mclean Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 Geneceptâ„¢ 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.


Recruitment information / eligibility

Status Completed
Enrollment 75
Est. completion date July 31, 2020
Est. primary completion date July 12, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

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

Locations

Country Name City State
United States McLean Hospital Belmont Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Mclean Hospital Genomind, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
See also
  Status Clinical Trial Phase
Recruiting NCT05537558 - Precision Medicine for the Prediction of Treatment (PROMPT) Response (PROMPT)
Terminated NCT02192099 - Open Label Extension for GLYX13-C-202, NCT01684163 Phase 2
Completed NCT03142919 - Lipopolysaccharide (LPS) Challenge in Depression Phase 2
Recruiting NCT05547035 - Identification of Physiological Data by a Wearable Monitor in Subjects Suffering From Major Depression Disorders N/A
Terminated NCT02940769 - Neurobiological Effects of Light on MDD N/A
Recruiting NCT05892744 - Establishing Multimodal Brain Biomarkers for Treatment Selection in Depression Phase 4
Recruiting NCT05537584 - SMART Trial to Predict Anhedonia Response to Antidepressant Treatment Phase 4
Active, not recruiting NCT05061706 - Multicenter Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder Phase 3
Completed NCT04479852 - A Study of the Safety and Efficacy of SP-624 in the Treatment of Adults With Major Depressive Disorder Phase 2
Recruiting NCT04032301 - Repeated Ketamine Infusions for Comorbid PTSD and MDD in Veterans Phase 1
Recruiting NCT05527951 - Enhanced Measurement-Based Care Effectiveness for Depression (EMBED) Study N/A
Completed NCT03511599 - Cycloserine rTMS Plasticity Augmentation in Depression Phase 1
Recruiting NCT04392947 - Treatment of Major Depressive Disorder With Bilateral Theta Burst Stimulation N/A
Recruiting NCT05895747 - 5-HTP and Creatine for Depression R33 Phase Phase 2
Recruiting NCT05273996 - Predictors of Cognitive Outcomes in Geriatric Depression Phase 4
Recruiting NCT05813093 - Interleaved TMS-fMRI in Ultra-treatment Resistant Depression N/A
Recruiting NCT05135897 - The Neurobiological Fundaments of Depression and Its Relief Through Neurostimulation Treatments
Enrolling by invitation NCT04509102 - Psychostimulant Augmentation of Repetitive TMS for the Treatment of Major Depressive Disorder Early Phase 1
Recruiting NCT06026917 - Assessing Dopamine Transporter Occupancy in the Patients With Depression Brain With Toludesvenlafaxine Hydrochloride Extended-Release Tablets Using 11C-CFT Positron Emission Tomography (PET) Phase 4
Recruiting NCT06145594 - EMA-Guided Maintenance TMS for Depression N/A