Combinatorial Pharmacogenomics Testing in Treatment-Naïve Major Depressive Disorder

NCT ID: NCT03537547

Last Updated: 2020-06-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-04
• Study Completion Date: 2019-08-19

Brief Summary

This study aims to determine whether the GeneSight Psychotropic test can result in better treatment outcomes for patients with treatment-naive major depressive disorder

Detailed Description

Major Depressive Disorder is a chronic psychiatric illness that leads to devastating consequences at the individual and societal levels. Today, the choice of treatment continues to be largely based on subjective factors, primarily the clinician and/or patient's preferences, as well as the individual's history of response to treatment, often tainted by recall bias. Psychiatric medication decisions are even more arbitrary when the subject in question has not had past treatment trials. This often leads to a trial and error process and an increasingly resistant disease with each failed trial. Early implementation of an objective tool designed for tailoring medication choice to an individual may prove highly beneficial in decreasing illness chronicity, individual suffering, and economic burden.

GeneSight Psychotropic test is a pharmacogenomic decision support tool, developed to help clinicians make informed, evidence-based decisions about proper drug selection. Therefore, we propose conducting a randomized, double blind, controlled trial to evaluate the impact of the GeneSight Psychotropic test to guide treatment decisions in patients with treatment-naïve (never having taken medication for depression) Major Depressive Disorder.

This study will involve 6 visits over about 24 weeks where participants will be randomized to have their study clinician have access to their pharmacogenetic report in order to make treatment decisions, or to not have access to their report for the first 12 weeks. At Visit 5, Week 12, all participants will receive a copy of their pharmacogenetics report and all clinicians will be unblinded to be able to use the results to guide treatment options for an additional 12 weeks.

Conditions

Major Depressive Disorder; Depression; Depressive Disorder; Depressive Episode; Depression, Unipolar

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

GeneSight Psychotropic test

Participants randomized to have their study clinician have access to their pharmacogenetic report (provided through the GeneSight Psychotropic tool) in order to make treatment decisions for the first 12 weeks. At Visit 5, Week 12, participants will receive a copy of their pharmacogenetics report and clinicians will continue to be able to use the results to guide treatment options for an additional 12 weeks.

Group Type: EXPERIMENTAL

GeneSight Psychotropic test

Intervention Type: OTHER

GeneSight Psychotropic test, developed by AssureRx Health, is a genetic test that analyses pre-selected pharmacokinetics and pharmacodynamics genes and results in a composite phenotype and interpretive report, addressing both safety and efficacy of psychiatric medications.

FDA-approved antidepressant or antipsychotic treatment

Intervention Type: DRUG

Participant is treated with medications included in the GeneSight Psychotropic product.

Treatment As Usual

Participants randomized to treatment as usual will receive treatment from study clinicians who do not have access to the participant's report for the first 12 weeks. At Visit 5, Week 12, participants will receive a copy of their pharmacogenetics report and clinicians will be unblinded to be able to use the results to guide treatment options for an additional 12 weeks.

Group Type: ACTIVE_COMPARATOR

FDA-approved antidepressant or antipsychotic treatment

Intervention Type: DRUG

Participant is treated with medications included in the GeneSight Psychotropic product.

Interventions

GeneSight Psychotropic test

GeneSight Psychotropic test, developed by AssureRx Health, is a genetic test that analyses pre-selected pharmacokinetics and pharmacodynamics genes and results in a composite phenotype and interpretive report, addressing both safety and efficacy of psychiatric medications.

Intervention Type: OTHER

FDA-approved antidepressant or antipsychotic treatment

Participant is treated with medications included in the GeneSight Psychotropic product.

Intervention Type: DRUG

Other Intervention Names

GeneSight test

Eligibility Criteria

Inclusion Criteria

1. Adults 18-65 years of age

2. Treatment-naïve major depressive disorder meeting Diagnostic and Statistical Manual 4th Edition (DSM-IV) criteria, without psychosis

3. Total baseline score on the Quick Inventory Of Depressive Symptomatology Clinician-rated (QIDS-C16) and the Quick Inventory Of Depressive Symptomatology Self-Report (QIDS-SR16) rating scale ≥11

4. Good command of the English language

Exclusion Criteria

1. Patients with a current diagnosis of schizophrenia

2. Patients with a current diagnosis of schizoaffective disorder

3. Patients with a current diagnosis of bipolar disorder (any type)

4. Currently meeting DSM-IV criteria for significant substance use disorder (exception: nicotine use disorder)

5. A diagnosis of personality disorder that may interfere with the patient's ability to improve on pharmacologic treatment, as determined by study investigator

6. Patients currently receiving electroconvulsive therapy(ECT), deep brain stimulation (DBS) or transcranial magnetic stimulation (TMS) treatment

7. History of hypothyroidism unless taking a stable dose of thyroid medication and asymptomatic or euthyroid for 6 months

8. Significant unstable medical condition; life threatening disease; hepatic insufficiency; liver transplant recipient; cirrhosis of the liver; need for therapies that may obscure the results of treatment and/or of the study; malignancy (except basal cell carcinoma) and/or chemotherapy within 1 year prior to screening; malignancy more than 1 year prior to screening must have been local and without metastasis and/or recurrence, and if treated with chemotherapy, without nervous system complications

9. History of gastric bypass surgery

10. Acute suicidal intention and/or in need of immediate hospitalization as judged by the investigator

11. Active psychotic symptoms

12. Currently in an inpatient facility

13. History of prior pharmacogenomic testing

14. Currently pregnant or lactating

15. Inability to provide informed consent

16. Any other factor that in the investigators' judgment may affect patient safety or compliance

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AssureRx Health, Inc.

INDUSTRY

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Charles Conway, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University School of Medicine

St Louis, Missouri, United States

Countries

United States

Other Identifiers

201609109

Identifier Type: -

Identifier Source: org_study_id