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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.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Outcomes Assessor);   Primary Purpose: Treatment
Condition Major Depressive Disorder (MDD)
Intervention Genetic: GeneSight Psychotropic
Enrollment 1398
Recruitment Details  
Pre-assignment Details  
Arm/Group Title GeneSight Psychotropic Tested Treatment As Usual
Hide Arm/Group Description

Subjects being tested with GeneSight Psychotropic

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.

This group of subjects will not see their GeneSIght results or know whether or not they are in either arm.

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.

Period Title: Overall Study
Started 681 717
Completed 560 607
Not Completed 121 110
Arm/Group Title GeneSight Psychotropic Tested Treatment As Usual Total
Hide Arm/Group Description

Subjects being tested with GeneSight Psychotropic

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.

This group of subjects will not see their GeneSIght results or know whether or not they are in either arm.

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.

Total of all reporting groups
Overall Number of Baseline Participants 681 717 1398
Hide Baseline Analysis Population Description
Per Protocol Population at Baseline
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 681 participants 717 participants 1398 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
597
  87.7%
616
  85.9%
1213
  86.8%
>=65 years
84
  12.3%
101
  14.1%
185
  13.2%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 681 participants 717 participants 1398 participants
46.9  (14.5) 48.0  (50.0) 47.5  (14.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 681 participants 717 participants 1398 participants
Female
489
  71.8%
498
  69.5%
987
  70.6%
Male
192
  28.2%
219
  30.5%
411
  29.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 681 participants 717 participants 1398 participants
American Indian or Alaska Native
5
   0.7%
3
   0.4%
8
   0.6%
Asian
12
   1.8%
17
   2.4%
29
   2.1%
Native Hawaiian or Other Pacific Islander
1
   0.1%
0
   0.0%
1
   0.1%
Black or African American
114
  16.7%
94
  13.1%
208
  14.9%
White
538
  79.0%
589
  82.1%
1127
  80.6%
More than one race
11
   1.6%
14
   2.0%
25
   1.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 681 participants 717 participants 1398 participants
681 717 1398
Baseline HAM-D17   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 681 participants 717 participants 1398 participants
21.1  (4.20) 21.4  (4.22) 21.3  (4.21)
[1]
Measure Description: HAM-D17 score at baseline
1.Primary Outcome
Title Percent Change in the 17-item Hamilton Depression (HAM-D17) Score From Baseline to 8 Weeks
Hide Description 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.
Time Frame from baseline to end of Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol
Arm/Group Title Treatment As Usual GeneSight Psychotropic Tested
Hide Arm/Group Description:

This group of subjects will not have treatment guided by their GeneSight results or know whether they are in a particular arm.

GeneSight Psychotropic: The GeneSight Psychotropic product is a pharmacogenomic decision support tool that helps clinicians 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, one MAOI, and typical and atypical antipsychotics are also represented.

Subjects being tested with GeneSight Psychotropic. This group of subjects will not know whether they are in a particular arm.

GeneSight Psychotropic: The GeneSight Psychotropic product is a pharmacogenomic decision support tool that helps clinicians 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, one MAOI, and typical and atypical antipsychotics are also represented.

Overall Number of Participants Analyzed 607 560
Least Squares Mean (Standard Error)
Unit of Measure: percentage of change
-24.39  (1.22) -27.23  (1.27)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment As Usual, GeneSight Psychotropic Tested
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1070
Comments [Not Specified]
Method Mixed Models Analysis
Comments Repeated Measures including week 4.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.836
Confidence Interval (2-Sided) 95%
-6.285 to 0.613
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.758
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percent Change in the 16-item Quick Inventory of Depression Symptomology (QIDS-C16) Score From Baseline to 8 Weeks
Hide Description 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.
Time Frame from baseline to end of Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat
Arm/Group Title GeneSight Psychotropic Tested Treatment As Usual
Hide Arm/Group Description:

Subjects being tested with GeneSight Psychotropic. This group of subjects will not know whether they are in a particular arm.

GeneSight Psychotropic: The GeneSight Psychotropic product is a pharmacogenomic decision support tool that helps clinicians 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, one MAOI, and typical and atypical antipsychotics are also represented.

This group of subjects will not have treatment guided by their GeneSight results or know whether they are in a particular arm.

GeneSight Psychotropic: The GeneSight Psychotropic product is a pharmacogenomic decision support tool that helps clinicians 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, one MAOI, and typical and atypical antipsychotics are also represented.

Overall Number of Participants Analyzed 621 677
Least Squares Mean (Standard Error)
Unit of Measure: percentage of change
-35.107  (1.189) -32.900  (1.147)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GeneSight Psychotropic Tested, Treatment As Usual
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1822
Comments [Not Specified]
Method Mixed Models Analysis
Comments MMRM with week 4 data.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.207
Confidence Interval (2-Sided) 95%
-5.450 to 1.036
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.653
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Responders at Week 8 for HAM-D17
Hide Description 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.
Time Frame Week 8 visit info
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol
Arm/Group Title GeneSight Psychotropic Tested Treatment As Usual
Hide Arm/Group Description:

Subjects being tested with GeneSight Psychotropic

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.

This group of subjects will not see their GeneSIght results or know whether or not they are in either arm.

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.

Overall Number of Participants Analyzed 560 607
Measure Type: Number
Unit of Measure: percentage of subjects
26.00 19.92
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GeneSight Psychotropic Tested, Treatment As Usual
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0134
Comments [Not Specified]
Method Generalized linear mixed model
Comments The reported outcome measure is the estimated percentage from a generalized linear mixed model, not a simple count of subjects.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.41
Confidence Interval (2-Sided) 95%
1.07 to 1.86
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Responders at Week 12 for HAM-D17
Hide Description *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.
Time Frame Week 12 visit info
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Percentage of Remitters at Week 12 Defined as HAM-D17 ≤7
Hide Description *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.
Time Frame week 12 visit info
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Percentage of Remitters at Week 8 Defined as HAM-D17 ≤7 Each Treatment Group;
Hide Description 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.
Time Frame week 8 visit info
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol
Arm/Group Title GeneSight Psychotropic Tested Treatment As Usual
Hide Arm/Group Description:

Subjects being tested with GeneSight Psychotropic

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.

This group of subjects will not see their GeneSIght results or know whether or not they are in either arm.

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.

Overall Number of Participants Analyzed 560 607
Measure Type: Number
Unit of Measure: percentage of subjects
15.30 10.08
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GeneSight Psychotropic Tested, Treatment As Usual
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0066
Comments [Not Specified]
Method Generalized linear mixed model
Comments The reported outcome measure is the estimated percentage from a generalized linear mixed model, not a simple count of subjects.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.61
Confidence Interval (2-Sided) 95%
1.14 to 2.27
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Time to Response/Remission of Depressive Symptoms Over 8 Weeks;
Hide Description *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.
Time Frame week 4 and 8 visit info
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Percent Change in the 17-item Hamilton Depression (HAM-D17) Score From Baseline to 24 Weeks
Hide Description 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.
Time Frame Baseline to week 24 visits
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol - Due to unblinding before week 12 there was no longer a treatment as usual and guided treatment arm and it was pre-specified in the Protocol to include only the GeneSight Psychotropic Tested Arm/Group for this Outcome Measure
Arm/Group Title GeneSight Psychotropic Tested
Hide Arm/Group Description:

Subjects being tested with GeneSight Psychotropic

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.

Overall Number of Participants Analyzed 457
Mean (Standard Error)
Unit of Measure: percentage of change
42.5  (1.52)
9.Secondary Outcome
Title Percentage of Responders at Week 8 for QIDS-C16
Hide Description 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.
Time Frame Week 8 visit info
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title GeneSight Psychotropic Tested Treatment As Usual
Hide Arm/Group Description:

Subjects being tested with GeneSight Psychotropic

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.

This group of subjects will not see their GeneSIght results or know whether or not they are in either arm.

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.

Overall Number of Participants Analyzed 677 621
Measure Type: Number
Unit of Measure: percentage of subjects
34.14 31.36
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GeneSight Psychotropic Tested, Treatment As Usual
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2852
Comments [Not Specified]
Method Generalized linear mixed model.
Comments The reported outcome measure is the estimated percentage from a generalized linear mixed model, not a simple count of subjects.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.13
Confidence Interval (2-Sided) 95%
0.90 to 1.43
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Percentage of Responders at Week 8 for PHQ-9
Hide Description 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.
Time Frame Week 8 visit info
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Treatment As Usual GeneSight Psychotropic Tested
Hide Arm/Group Description:

This group of subjects will not have treatment guided by their GeneSight results or know whether they are in a particular arm.

GeneSight Psychotropic: The GeneSight Psychotropic product is a pharmacogenomic decision support tool that helps clinicians 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, one MAOI, and typical and atypical antipsychotics are also represented.

Subjects being tested with GeneSight Psychotropic. This group of subjects will not know whether they are in a particular arm.

GeneSight Psychotropic: The GeneSight Psychotropic product is a pharmacogenomic decision support tool that helps clinicians 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, one MAOI, and typical and atypical antipsychotics are also represented.

Overall Number of Participants Analyzed 676 620
Measure Type: Number
Unit of Measure: percentage of subjects
31.63 39.74
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment As Usual, GeneSight Psychotropic Tested
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0023
Comments [Not Specified]
Method Generalized linear mixed model
Comments The reported outcome measure is the estimated percentage from a generalized linear mixed model, not a simple count of subjects.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.43
Confidence Interval (2-Sided) 95%
1.14 to 1.79
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Percentage of Remitters at Week 12 Defined as QIDS-C16 ≤5
Hide Description *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.
Time Frame week 12 visit info
Outcome Measure Data Not Reported
12.Secondary Outcome
Title Percentage of Remitters at Week 12 Defined as PHQ-9 <5
Hide Description *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.
Time Frame week 12 visit info
Outcome Measure Data Not Reported
13.Secondary Outcome
Title Percentage of Remitters at Week 12 Defined as CGI-S ≤1
Hide Description *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.
Time Frame week 12 visit info
Outcome Measure Data Not Reported
14.Secondary Outcome
Title Percentage of Responders at Week 12 for QIDS-C16
Hide Description *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.
Time Frame Week 12 visit info
Outcome Measure Data Not Reported
15.Secondary Outcome
Title Percentage of Responders at Week 12 for PHQ-9
Hide Description *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.
Time Frame Week 12 visit info
Outcome Measure Data Not Reported
16.Secondary Outcome
Title Percentage of Responders at Week 12 for CGI-S
Hide Description *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.
Time Frame Week 12 visit info
Outcome Measure Data Not Reported
17.Secondary Outcome
Title Percentage of Responders at Week 12 for CGI-I
Hide Description *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.
Time Frame Week 12 visit info
Outcome Measure Data Not Reported
18.Secondary Outcome
Title Percentage of Responders at Week 12 for CGI-EI
Hide Description *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.
Time Frame Week 12 visit info
Outcome Measure Data Not Reported
19.Secondary Outcome
Title Percentage of Remitters at Week 8 Defined as QIDS-C16 ≤ 5 in Each Treatment Group
Hide Description 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.
Time Frame week 8 visit info
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Treatment As Usual GeneSight Psychotropic Tested
Hide Arm/Group Description:

This group of subjects will not have treatment guided by their GeneSight results or know whether they are in a particular arm.

GeneSight Psychotropic: The GeneSight Psychotropic product is a pharmacogenomic decision support tool that helps clinicians 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, one MAOI, and typical and atypical antipsychotics are also represented.

Subjects being tested with GeneSight Psychotropic. This group of subjects will not know whether they are in a particular arm.

GeneSight Psychotropic: The GeneSight Psychotropic product is a pharmacogenomic decision support tool that helps clinicians 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, one MAOI, and typical and atypical antipsychotics are also represented.

Overall Number of Participants Analyzed 677 621
Measure Type: Number
Unit of Measure: percentage of subjects
15.62 20.89
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment As Usual, GeneSight Psychotropic Tested
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0140
Comments [Not Specified]
Method Generalized linear mixed model
Comments The reported outcome measure is the estimated percentage from a generalized linear mixed model, not a simple count of subjects.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.43
Confidence Interval (2-Sided) 95%
1.07 to 1.89
Estimation Comments [Not Specified]
20.Secondary Outcome
Title Percentage of Remitters at Week 8 Defined as PHQ-9 <5 in Each Treatment Group
Hide Description 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.
Time Frame week 8 visit info
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Treatment As Usual GeneSight Psychotropic Tested
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This group of subjects will not have treatment guided by their GeneSight results or know whether they are in a particular arm.

GeneSight Psychotropic: The GeneSight Psychotropic product is a pharmacogenomic decision support tool that helps clinicians 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, one MAOI, and typical and atypical antipsychotics are also represented.

Subjects being tested with GeneSight Psychotropic. This group of subjects will not know whether they are in a particular arm.

GeneSight Psychotropic: The GeneSight Psychotropic product is a pharmacogenomic decision support tool that helps clinicians 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, one MAOI, and typical and atypical antipsychotics are also represented.

Overall Number of Participants Analyzed 677 620
Measure Type: Number
Unit of Measure: percentage of subjects
14.79 18.58
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment As Usual, GeneSight Psychotropic Tested
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0663
Comments [Not Specified]
Method Generalized linear mixed model
Comments The reported outcome measure is the estimated percentage from a generalized linear mixed model, not a simple count of subjects.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.31
Confidence Interval (2-Sided) 95%
0.98 to 1.76
Estimation Comments [Not Specified]
21.Secondary Outcome
Title Time to Response/Remission of Depressive Symptoms Over 12 Weeks;
Hide Description *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.
Time Frame week 4, 8, and 12 visit info
Outcome Measure Data Not Reported
22.Secondary Outcome
Title Percentage of Responders at Week 24 for HAM-D17 in the GeneSight Psychotropic Tested Treatment Group
Hide Description 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.
Time Frame Baseline to week 24 visit info
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Per Protocol
Arm/Group Title GeneSight Psychotropic Tested
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Subjects being tested with GeneSight Psychotropic

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.

Overall Number of Participants Analyzed 457
Measure Type: Number
Unit of Measure: percentage of subjects
44.3
23.Secondary Outcome
Title Percentage of Remitters at Week 24 Defined as HAM-D17 ≤7 in the GeneSight Psychotropic Tested Treatment Group
Hide Description

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.

Time Frame Baseline to week 24 visit info
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Per Protocol
Arm/Group Title GeneSight Psychotropic Tested
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Subjects being tested with GeneSight Psychotropic

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.

Overall Number of Participants Analyzed 457
Measure Type: Number
Unit of Measure: percentage of subjects
31.1
24.Other Pre-specified Outcome
Title Generalized Anxiety Disorder 7-item (GAD-7) Scale
Hide Description The mean change in Generalized Anxiety Disorder 7-item (GAD-7) scale from week 12 to week 24
Time Frame week 12 to week 24
Outcome Measure Data Not Reported
25.Other Pre-specified Outcome
Title Generalized Anxiety Disorder 7-item (GAD-7) Scale
Hide Description The mean change in Generalized Anxiety Disorder 7-item (GAD-7) scale from baseline to week 8
Time Frame baseline to week 8
Outcome Measure Data Not Reported
26.Other Pre-specified Outcome
Title Generalized Anxiety Disorder 7-item (GAD-7) Scale
Hide Description The mean change in Generalized Anxiety Disorder 7-item (GAD-7) scale from baseline to week 12
Time Frame baseline to week 12
Outcome Measure Data Not Reported
Time Frame 8 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title GeneSight Psychotropic Tested Treatment As Usual
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Subjects being tested with GeneSight Psychotropic

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.

This group of subjects will not see their GeneSIght results or know whether or not they are in either arm.

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.

All-Cause Mortality
GeneSight Psychotropic Tested Treatment As Usual
Affected / at Risk (%) Affected / at Risk (%)
Total   0/681 (0.00%)      0/717 (0.00%)    
Hide Serious Adverse Events
GeneSight Psychotropic Tested Treatment As Usual
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/681 (0.44%)      2/717 (0.28%)    
Gastrointestinal disorders     
Gastrointestinal hemorrhage  1  0/681 (0.00%)  0 1/717 (0.14%)  1
General disorders     
non cardiac chest pains  1  0/681 (0.00%)  0 1/717 (0.14%)  1
Metabolism and nutrition disorders     
transient hypoglycemia  1  1/681 (0.15%)  1 0/717 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Muscle twitching  1  1/681 (0.15%)  1 0/717 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Pulmonary embolism  1  1/681 (0.15%)  1 0/717 (0.00%)  0
1
Term from vocabulary, MedDRA (Unspecified)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
GeneSight Psychotropic Tested Treatment As Usual
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/681 (0.00%)      0/717 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
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Name/Title: Lindsey Burns
Organization: Assurex Health
Phone: 5137015068
EMail: lindsey.burns@myriad.com
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Responsible Party: Assurex Health Inc.
ClinicalTrials.gov Identifier: NCT02109939    
Other Study ID Numbers: ARX1006
First Submitted: April 4, 2014
First Posted: April 10, 2014
Results First Submitted: October 14, 2019
Results First Posted: January 14, 2020
Last Update Posted: January 14, 2020