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Trial record 1 of 1 for:    NCT02109939
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Genomics Used to Improve DEpression Decisions (GUIDED)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02109939
Recruitment Status : Completed
First Posted : April 10, 2014
Results First Posted : January 14, 2020
Last Update Posted : January 14, 2020
Sponsor:
Collaborator:
University of Michigan
Information provided by (Responsible Party):
Assurex Health Inc.

Brief Summary:
Evaluate the impact of GeneSight Psychotropic on response to psychotropic treatment as judged by the mean change in the 17-item Hamilton Depression (HAM-D17) score from baseline to end of Week 8 of the study.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder (MDD) Genetic: GeneSight Psychotropic Not Applicable

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1398 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 12 Week, Randomized, Double-Blind, Controlled Evaluation Followed by an Open Label 12-Week Follow-up Period of the Impact of GeneSight Psychotropic on Response to Psychotropic Treatment in Outpatients Suffering From A Major Depressive Disorder (MDD) Having Had- Within the Current Episode- An Inadequate Response to at Least One Medication Included in GeneSight Psychotropic
Actual Study Start Date : April 2014
Actual Primary Completion Date : April 20, 2017
Actual Study Completion Date : July 31, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: GeneSight Psychotropic Tested
Subjects being tested with GeneSight Psychotropic
Genetic: GeneSight Psychotropic

The GeneSight Psychotropic product is a pharmacogenomic decision support tool that helps clinicians to make informed, evidence-based decisions about proper drug selection, based on the testing for clinically important genetic variants in multiple pharmacokinetic and pharmacodynamic genes that affect a patient's ability to tolerate or respond to medications.

The GeneSight Psychotropic product contains the most commonly prescribed antidepressant and antipsychotic medications, including a full representation of the SSRI and SNRI drug classes.

tricyclic antidepressants, an MAOI, and typical and atypical antipsychotics are also represented.

Other Names:
  • Assurex Health
  • GeneSight

Placebo Comparator: Treatment As Usual
This group of subjects will not see their GeneSIght results or know whether or not they are in either arm until after week 12.
Genetic: GeneSight Psychotropic

The GeneSight Psychotropic product is a pharmacogenomic decision support tool that helps clinicians to make informed, evidence-based decisions about proper drug selection, based on the testing for clinically important genetic variants in multiple pharmacokinetic and pharmacodynamic genes that affect a patient's ability to tolerate or respond to medications.

The GeneSight Psychotropic product contains the most commonly prescribed antidepressant and antipsychotic medications, including a full representation of the SSRI and SNRI drug classes.

tricyclic antidepressants, an MAOI, and typical and atypical antipsychotics are also represented.

Other Names:
  • Assurex Health
  • GeneSight




Primary Outcome Measures :
  1. Percent Change in the 17-item Hamilton Depression (HAM-D17) Score From Baseline to 8 Weeks [ Time Frame: from baseline to end of Week 8 ]
    Evaluate the impact of GeneSight Psychotropic on response to psychotropic treatment as judged by the mean percent change in the 17-item Hamilton Depression (HAM-D17) score from baseline to end of Week 8 of the study. Scores range from 0 to 50, and lower scores are better outcomes. Percent change is defined as (week 8 score -baseline score) / (baseline score) x 100.


Secondary Outcome Measures :
  1. Percent Change in the 16-item Quick Inventory of Depression Symptomology (QIDS-C16) Score From Baseline to 8 Weeks [ Time Frame: from baseline to end of Week 8 ]
    Mean percent change in the 16-item Quick Inventory of Depression Symptomology (QIDS-C16) score from baseline to end of Week 8 of the study. Scores range from 0 to 27 with lower scores being better outcomes. Percent change is defined as (week 8 score - baseline score) / (baseline score) x 100.

  2. Percentage of Responders at Week 8 for HAM-D17 [ Time Frame: Week 8 visit info ]
    Adjusted percentage of responders at Week 8 in each treatment group on the 17-item Hamilton Depression Rating Scale (HAM-D17). A responder is defined as a participant with at least a 50% decrease from baseline in total scale score. Scores range from 0 to 50, and lower scores are better outcomes.

  3. Percentage of Responders at Week 12 for HAM-D17 [ Time Frame: Week 12 visit info ]
    *Comment*: For patients in TAU, clinicians were blinded to the pharmacogenomic test result until after completion of the week 8 visit. Because unblinding might have occurred for some patients prior to week 12 assessments, data collected at week 12 were no longer considered blinded and are not analyzed or reported.

  4. Percentage of Remitters at Week 12 Defined as HAM-D17 ≤7 [ Time Frame: week 12 visit info ]
    *Comment*: For patients in TAU, clinicians were blinded to the pharmacogenomic test result until after completion of the week 8 visit. Because unblinding might have occurred for some patients prior to week 12 assessments, data collected at week 12 were no longer considered blinded and are not analyzed or reported.

  5. Percentage of Remitters at Week 8 Defined as HAM-D17 ≤7 Each Treatment Group; [ Time Frame: week 8 visit info ]
    Adjusted percentage of remitters at Week 8 defined as a score ≤7 in the 17-item Hamilton Depression Rating Scale (HAM-D17) in each treatment group. Scores range from 0 to 50, and lower scores are better outcomes.

  6. Time to Response/Remission of Depressive Symptoms Over 8 Weeks; [ Time Frame: week 4 and 8 visit info ]
    *Comment*: Time to response/remission is not an outcome measure that can accurately be reported from the way the data was collected. As specified in the updated SAP before the blind was broken, this was not analyzed or reported.

  7. Percent Change in the 17-item Hamilton Depression (HAM-D17) Score From Baseline to 24 Weeks [ Time Frame: Baseline to week 24 visits ]
    Evaluate the impact of GeneSight Psychotropic on response to psychotropic treatment as judged by the mean percent change in the 17-item Hamilton Depression (HAM-D17) score from baseline to end of Week 24 of the study. Scores range from 0 to 50, and lower scores are better outcomes. Percent change is defined as (week 24 score -baseline score) / (baseline score) x 100.

  8. Percentage of Responders at Week 8 for QIDS-C16 [ Time Frame: Week 8 visit info ]
    Adjusted percentage of responders at Week 8 in each treatment group on the 16-item Quick Inventory of Depression Symptomology (QIDS-C16). A responder is defined as a participant with at least 50% decrease from baseline in total scale score. Scores range from 0 to 27 with lower scores being better outcomes.

  9. Percentage of Responders at Week 8 for PHQ-9 [ Time Frame: Week 8 visit info ]
    Adjusted percentage of responders at Week 8 in each treatment group on the 9-item Patient Health Questionnaire (PHQ-9). A responder is defined as a participant with at least 50% decrease from baseline in total scale score. Scores range from 0 to 27 with lower scores being better outcomes.

  10. Percentage of Remitters at Week 12 Defined as QIDS-C16 ≤5 [ Time Frame: week 12 visit info ]
    *Comment*: For patients in TAU, clinicians were blinded to the pharmacogenomic test result until after completion of the week 8 visit. Because unblinding might have occurred for some patients prior to week 12 assessments, data collected at week 12 were no longer considered blinded and are not analyzed or reported.

  11. Percentage of Remitters at Week 12 Defined as PHQ-9 <5 [ Time Frame: week 12 visit info ]
    *Comment*: For patients in TAU, clinicians were blinded to the pharmacogenomic test result until after completion of the week 8 visit. Because unblinding might have occurred for some patients prior to week 12 assessments, data collected at week 12 were no longer considered blinded and are not analyzed or reported.

  12. Percentage of Remitters at Week 12 Defined as CGI-S ≤1 [ Time Frame: week 12 visit info ]
    *Comment*: For patients in TAU, clinicians were blinded to the pharmacogenomic test result until after completion of the week 8 visit. Because unblinding might have occurred for some patients prior to week 12 assessments, data collected at week 12 were no longer considered blinded and are not analyzed or reported.

  13. Percentage of Responders at Week 12 for QIDS-C16 [ Time Frame: Week 12 visit info ]
    *Comment*: For patients in TAU, clinicians were blinded to the pharmacogenomic test result until after completion of the week 8 visit. Because unblinding might have occurred for some patients prior to week 12 assessments, data collected at week 12 were no longer considered blinded and are not analyzed or reported.

  14. Percentage of Responders at Week 12 for PHQ-9 [ Time Frame: Week 12 visit info ]
    *Comment*: For patients in TAU, clinicians were blinded to the pharmacogenomic test result until after completion of the week 8 visit. Because unblinding might have occurred for some patients prior to week 12 assessments, data collected at week 12 were no longer considered blinded and are not analyzed or reported.

  15. Percentage of Responders at Week 12 for CGI-S [ Time Frame: Week 12 visit info ]
    *Comment*: For patients in TAU, clinicians were blinded to the pharmacogenomic test result until after completion of the week 8 visit. Because unblinding might have occurred for some patients prior to week 12 assessments, data collected at week 12 were no longer considered blinded and are not analyzed or reported.

  16. Percentage of Responders at Week 12 for CGI-I [ Time Frame: Week 12 visit info ]
    *Comment*: For patients in TAU, clinicians were blinded to the pharmacogenomic test result until after completion of the week 8 visit. Because unblinding might have occurred for some patients prior to week 12 assessments, data collected at week 12 were no longer considered blinded and are not analyzed or reported.

  17. Percentage of Responders at Week 12 for CGI-EI [ Time Frame: Week 12 visit info ]
    *Comment*: For patients in TAU, clinicians were blinded to the pharmacogenomic test result until after completion of the week 8 visit. Because unblinding might have occurred for some patients prior to week 12 assessments, data collected at week 12 were no longer considered blinded and are not analyzed or reported.

  18. Percentage of Remitters at Week 8 Defined as QIDS-C16 ≤ 5 in Each Treatment Group [ Time Frame: week 8 visit info ]
    Adjusted percentage of remitters at Week 8 in the 16-item Quick Inventory of Depression Symptomology (QIDS-C16) in each treatment group. A remitter is defined as a subject with a score ≤ 5. Scores range from 0 to 27 with lower scores being better outcomes.

  19. Percentage of Remitters at Week 8 Defined as PHQ-9 <5 in Each Treatment Group [ Time Frame: week 8 visit info ]
    Adjusted percentage of remitters at Week 8 in each treatment group on the 9-item Patient Health Questionnaire (PHQ-9). A remitter is defined as a participant with score <5 on the PHQ-9. Scores range from 0 to 27 with lower scores being better outcomes.

  20. Time to Response/Remission of Depressive Symptoms Over 12 Weeks; [ Time Frame: week 4, 8, and 12 visit info ]
    *Comment*: Time to response/remission is not an outcome measure that can accurately be reported from the way the data was collected. As specified in the updated SAP before the blind was broken, this was not analyzed and reported. Additionally, for patients in TAU, clinicians were blinded to the pharmacogenomic test result until after completion of the week 8 visit. Because unblinding may have occurred prior to week 12 assessments, data collected at week 12 were considered unblinded and are not reported.

  21. Percentage of Responders at Week 24 for HAM-D17 in the GeneSight Psychotropic Tested Treatment Group [ Time Frame: Baseline to week 24 visit info ]
    Adjusted percentage of responders at Week 24 in the GeneSight Psychotropic Tested treatment group on the 17-item Hamilton Depression Rating Scale (HAM-D17). A responder is defined as a participant with at least a 50% decrease from baseline in total scale score. Scores range from 0 to 50, and lower scores are better outcomes.

  22. Percentage of Remitters at Week 24 Defined as HAM-D17 ≤7 in the GeneSight Psychotropic Tested Treatment Group [ Time Frame: Baseline to week 24 visit info ]

    Adjusted percentage of remitters at Week 8 defined as a score ≤7 in the 17-item Hamilton Depression Rating Scale (HAM-D17) in each treatment group. Scores range from 0 to 50, and lower scores are better outcomes.

    *Comment*: For patients in TAU, clinicians were blinded to the pharmacogenomic test result until after completion of the week 8 visit. Because unblinding may have occurred prior to week 12 assessments, all data collected at week 12 were considered unblinded and are not reported.



Other Outcome Measures:
  1. Generalized Anxiety Disorder 7-item (GAD-7) Scale [ Time Frame: week 12 to week 24 ]
    The mean change in Generalized Anxiety Disorder 7-item (GAD-7) scale from week 12 to week 24

  2. Generalized Anxiety Disorder 7-item (GAD-7) Scale [ Time Frame: baseline to week 8 ]
    The mean change in Generalized Anxiety Disorder 7-item (GAD-7) scale from baseline to week 8

  3. Generalized Anxiety Disorder 7-item (GAD-7) Scale [ Time Frame: baseline to week 12 ]
    The mean change in Generalized Anxiety Disorder 7-item (GAD-7) scale from baseline to week 12



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Be able to understand the requirements of the study and provide written informed consent to participate in this study; a signed and dated ICF will be obtained from each patient before participation in the study;
  • Have provided written authorization for the use and disclosure of their protected health information;
  • Be ≥18 years of age;
  • Suffer from a Major Depressive Episode meeting DSM-IV-TR criteria;
  • Have had an inadequate response within the current episode to at least 1 psychotropic treatment. Inadequate response is defined as inadequate efficacy after 6 weeks of a psychotropic treatment or discontinuation of a psychotropic treatment due to AEs or intolerability;
  • Have a total baseline score on the QIDS-C16 and QIDS-SR16 rating scale ≥11;
  • Agree to abide by the study protocol and its restrictions and be able to complete all aspects of the study, including all visits and tests.

Exclusion Criteria:

  • Patients posing a serious suicidal risk and/or in need of immediate hospitalization as judged by the investigator;
  • Patients with a diagnosis of Bipolar I or II disorder;
  • Patients with a current Axis I diagnosis of:

    1. Delirium
    2. Dementia
    3. Amnestic and other cognitive disorder
    4. Schizophrenia or other psychotic disorder;
  • Patients having experienced hallucinations, delusions, or any psychotic symptomatology within the current depressive episode or during prior depressive episodes;
  • Patient is currently in an inpatient facility;
  • Patients with a history of hypothyroidism unless taking a stable dose of thyroid medication and asymptomatic or euthyroid for 6 months;
  • Patients who meet DSM-IV-TR criteria for any significant current substance use disorder;
  • Patients with significant unstable medical condition; life threatening disease; hepatic insufficiency (3X ULN for AST and/or ALT); 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;
  • Participation in another clinical trial within 30 days of the screening visit;
  • Anticipated inability to attend scheduled study visits;
  • Patients who in the judgment of the Investigator may be unreliable or uncooperative with the evaluation procedure outlined in this protocol;
  • Patients with a history of prior pharmacogenomic testing;
  • Any change in psychotropic medication (including change in dosage) between screening and randomization;
  • Patients receiving ECT, DBS or TMS treatment (should a Subject receive any of these treatments they must be discontinued from the study);
  • Patients who are known to be pregnant or lactating;
  • Patients with a history of gastric bypass surgery.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02109939


Locations
Show Show 61 study locations
Sponsors and Collaborators
Assurex Health Inc.
University of Michigan
Investigators
Layout table for investigator information
Principal Investigator: John Greden, Ph.D University of Michigan
  Study Documents (Full-Text)

Documents provided by Assurex Health Inc.:
Study Protocol  [PDF] April 21, 2015
Statistical Analysis Plan  [PDF] August 17, 2016

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Assurex Health Inc.
ClinicalTrials.gov Identifier: NCT02109939    
Other Study ID Numbers: ARX1006
First Posted: April 10, 2014    Key Record Dates
Results First Posted: January 14, 2020
Last Update Posted: January 14, 2020
Last Verified: January 2020
Keywords provided by Assurex Health Inc.:
MDD
Pharmacogenomic
Pharmacogenomic Testing
Pharmacogenomics
Genetic Testing
Genetics
Major Depressive Disorder
GeneSight
Assurex
AssureRx
Psychotropic
Randomized
Double Blind
Placebo Controlled
Additional relevant MeSH terms:
Layout table for MeSH terms
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Psychotropic Drugs