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Combinatorial Pharmacogenomics Testing in Treatment-Naïve Major Depressive Disorder

Primary Purpose

Major Depressive Disorder, Depression, Depressive Disorder

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
GeneSight Psychotropic test
FDA-approved antidepressant or antipsychotic treatment
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring treatment naive, major depression, pharmacotherapy, pharmacogenomic, genomics

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Washington University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

GeneSight Psychotropic test

Treatment As Usual

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Hamilton Rating Scale for Depression change score- Week 4
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.
Hamilton Rating Scale for Depression change score- Week 12
17-item Hamilton Rating Scale for Depression (HAM-D17) to assess mean change in depressive symptoms severity. 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.
Hamilton Rating Scale for Depression change score- Week 24
17-item Hamilton Rating Scale for Depression (HAM-D17) to assess mean change in depressive symptoms severity. 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.

Full Information

First Posted
May 15, 2018
Last Updated
June 3, 2020
Sponsor
Washington University School of Medicine
Collaborators
AssureRx Health, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03537547
Brief Title
Combinatorial Pharmacogenomics Testing in Treatment-Naïve Major Depressive Disorder
Official Title
Combinatorial Pharmacogenomics Testing in Treatment-Naïve Major Depressive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Terminated
Why Stopped
Per sponsor and PI institution discussions
Study Start Date
May 4, 2018 (Actual)
Primary Completion Date
August 19, 2019 (Actual)
Study Completion Date
August 19, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
AssureRx Health, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder, Depression, Depressive Disorder, Depressive Episode, Depression, Unipolar
Keywords
treatment naive, major depression, pharmacotherapy, pharmacogenomic, genomics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantOutcomes Assessor
Masking Description
Coordinators at site are blinded, Sponsor and associates are unblinded.
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GeneSight Psychotropic test
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment As Usual
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
GeneSight Psychotropic test
Other Intervention Name(s)
GeneSight test
Intervention Description
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
Drug
Intervention Name(s)
FDA-approved antidepressant or antipsychotic treatment
Intervention Description
Participant is treated with medications included in the GeneSight Psychotropic product.
Primary Outcome Measure Information:
Title
Hamilton Rating Scale for Depression change score- Week 8
Description
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.
Time Frame
Baseline to Week 8
Secondary Outcome Measure Information:
Title
Hamilton Rating Scale for Depression change score- Week 4
Description
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.
Time Frame
Baseline to end of week 4
Title
Hamilton Rating Scale for Depression change score- Week 12
Description
17-item Hamilton Rating Scale for Depression (HAM-D17) to assess mean change in depressive symptoms severity. 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.
Time Frame
Baseline to end of week 12
Title
Hamilton Rating Scale for Depression change score- Week 24
Description
17-item Hamilton Rating Scale for Depression (HAM-D17) to assess mean change in depressive symptoms severity. 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.
Time Frame
Baseline to end of week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 Any other factor that in the investigators' judgment may affect patient safety or compliance
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles Conway, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

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Combinatorial Pharmacogenomics Testing in Treatment-Naïve Major Depressive Disorder

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