Combinatorial Pharmacogenomics Testing in Treatment-Naïve Major Depressive Disorder

NCT03537547 | Terminated Phase 4

• 1 other identifier: 201609109
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

treatment naive; major depression; pharmacotherapy; pharmacogenomic; genomics

Outcome Measures

Primary Outcomes (1)

• Hamilton Rating Scale for Depression change score- Week 8

  17-item Hamilton Rating Scale for Depression (HAM-D17) to assess mean change in depressive symptoms severity. Total range of the Hamilton Rating Scale for Depression is 0 to 52, with a greater score being an indication of more severe depressive symptoms.

  Baseline to Week 8

Secondary Outcomes (3)

• Hamilton Rating Scale for Depression change score- Week 4

  Baseline to end of week 4

• Hamilton Rating Scale for Depression change score- Week 12

  Baseline to end of week 12

• Hamilton Rating Scale for Depression change score- Week 24

  Baseline to end of week 24

Study Arms (2)

GeneSight Psychotropic test

EXPERIMENTAL

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.

Other: GeneSight Psychotropic test; Drug: FDA-approved antidepressant or antipsychotic treatment

Treatment As Usual

ACTIVE COMPARATOR

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.

Drug: FDA-approved antidepressant or antipsychotic treatment

Interventions

GeneSight Psychotropic test 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.

Also known as: GeneSight test

GeneSight Psychotropic test

FDA-approved antidepressant or antipsychotic treatment DRUG

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

GeneSight Psychotropic test; Treatment As Usual

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults 18-65 years of age
• Treatment-naïve major depressive disorder meeting Diagnostic and Statistical Manual 4th Edition (DSM-IV) criteria, without psychosis
• 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
• Good command of the English language

You may not qualify if:

• Patients with a current diagnosis of schizophrenia
• Patients with a current diagnosis of schizoaffective disorder
• Patients with a current diagnosis of bipolar disorder (any type)
• Currently meeting DSM-IV criteria for significant substance use disorder (exception: nicotine use disorder)
• A diagnosis of personality disorder that may interfere with the patient's ability to improve on pharmacologic treatment, as determined by study investigator
• Patients currently receiving electroconvulsive therapy(ECT), deep brain stimulation (DBS) or transcranial magnetic stimulation (TMS) treatment
• History of hypothyroidism unless taking a stable dose of thyroid medication and asymptomatic or euthyroid for 6 months
• 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
• History of gastric bypass surgery
• Acute suicidal intention and/or in need of immediate hospitalization as judged by the investigator
• Active psychotic symptoms
• Currently in an inpatient facility
• History of prior pharmacogenomic testing
• Currently pregnant or lactating
• Inability to provide informed consent

Sponsors & Collaborators

• Washington University School of Medicine: lead
• AssureRx Health, Inc.: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depression; Depressive Disorder

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Charles Conway, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Coordinators at site are blinded, Sponsor and associates are unblinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized to have their study clinician have access to their pharmacogenetic report (provide through the GeneSight Psychotropic tool) 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 for 'open label' to be able to use the results to guide treatment options for an additional 12 weeks.

Study Record Dates

• First Submitted: May 15, 2018
• First Posted: May 25, 2018
• Study Start: May 4, 2018
• Primary Completion: August 19, 2019
• Study Completion: August 19, 2019
• Last Updated: June 5, 2020

Record last verified: 2020-06

Locations

US (1)