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Combinatorial Pharmacogenomics Testing in Treatment-Naïve Major Depressive Disorder

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ClinicalTrials.gov Identifier: NCT03537547
Recruitment Status : Recruiting
First Posted : May 25, 2018
Last Update Posted : September 5, 2019
Sponsor:
Collaborator:
AssureRx Health, Inc.
Information provided by (Responsible Party):
Washington University School of Medicine

Tracking Information
First Submitted Date  ICMJE May 15, 2018
First Posted Date  ICMJE May 25, 2018
Last Update Posted Date September 5, 2019
Actual Study Start Date  ICMJE May 4, 2018
Estimated Primary Completion Date May 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 16, 2018)
Hamilton Rating Scale for Depression change score- Week 8 [ Time Frame: Baseline to 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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 15, 2018)
Hamilton Rating Scale for Depression change score- Week 8 [ Time Frame: Baseline to Week 8 ]
17-item Hamilton Rating Scale for Depression (HAM-D17) to assess mean change in depressive symptoms severity
Change History Complete list of historical versions of study NCT03537547 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 16, 2018)
  • Hamilton Rating Scale for Depression change score- Week 4 [ Time Frame: Baseline to end of 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 [ Time Frame: Baseline to end of 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 [ Time Frame: Baseline to end of 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 15, 2018)
  • Hamilton Rating Scale for Depression change score- Week 4 [ Time Frame: Baseline to end of week 4 ]
    17-item Hamilton Rating Scale for Depression (HAM-D17) to assess mean change in depressive symptoms severity
  • Hamilton Rating Scale for Depression change score- Week 12 [ Time Frame: Baseline to end of week 12 ]
    17-item Hamilton Rating Scale for Depression (HAM-D17) to assess mean change in depressive symptoms severity
  • Hamilton Rating Scale for Depression change score- Week 24 [ Time Frame: Baseline to end of week 24 ]
    17-item Hamilton Rating Scale for Depression (HAM-D17) to assess mean change in depressive symptoms severity
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Combinatorial Pharmacogenomics Testing in Treatment-Naïve Major Depressive Disorder
Official Title  ICMJE Combinatorial Pharmacogenomics Testing in Treatment-Naïve Major Depressive Disorder
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Double (Participant, Outcomes Assessor)
Masking Description:
Coordinators at site are blinded, Sponsor and associates are unblinded.
Primary Purpose: Treatment
Condition  ICMJE
  • Major Depressive Disorder
  • Depression
  • Depressive Disorder
  • Depressive Episode
  • Depression, Unipolar
Intervention  ICMJE
  • Other: 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.
    Other Name: GeneSight test
  • Drug: FDA-approved antidepressant or antipsychotic treatment
    Participant is treated with medications included in the GeneSight Psychotropic product.
Study Arms  ICMJE
  • Experimental: 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.
    Interventions:
    • Other: GeneSight Psychotropic test
    • Drug: FDA-approved antidepressant or antipsychotic treatment
  • Active Comparator: 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.
    Intervention: Drug: FDA-approved antidepressant or antipsychotic treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 15, 2018)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 31, 2021
Estimated Primary Completion Date May 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Britt Gott, MS 314-362-2463 gottb@wustl.edu
Contact: Araba Budu-Anguah, MPH 314-273-1921 abudu-anguah@wustl.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03537547
Other Study ID Numbers  ICMJE 201609109
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Washington University School of Medicine
Study Sponsor  ICMJE Washington University School of Medicine
Collaborators  ICMJE AssureRx Health, Inc.
Investigators  ICMJE
Principal Investigator: Charles Conway, MD Washington University School of Medicine
PRS Account Washington University School of Medicine
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP