Trial Outcomes & Findings for Genomics Used to Improve DEpression Decisions (NCT NCT02109939)
NCT ID: NCT02109939
Last Updated: 2020-01-14
Results Overview
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.
COMPLETED
NA
1398 participants
from baseline to end of Week 8
2020-01-14
Participant Flow
Participant milestones
| Measure |
GeneSight Psychotropic Tested
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.
|
Treatment As Usual
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 Study
STARTED
|
681
|
717
|
|
Overall Study
COMPLETED
|
560
|
607
|
|
Overall Study
NOT COMPLETED
|
121
|
110
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Genomics Used to Improve DEpression Decisions
Baseline characteristics by cohort
| Measure |
GeneSight Psychotropic Tested
n=681 Participants
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.
|
Treatment As Usual
n=717 Participants
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
n=1398 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
597 Participants
n=5 Participants
|
616 Participants
n=7 Participants
|
1213 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
84 Participants
n=5 Participants
|
101 Participants
n=7 Participants
|
185 Participants
n=5 Participants
|
|
Age, Continuous
|
46.9 years
STANDARD_DEVIATION 14.5 • n=5 Participants
|
48.0 years
STANDARD_DEVIATION 50.0 • n=7 Participants
|
47.5 years
STANDARD_DEVIATION 14.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
489 Participants
n=5 Participants
|
498 Participants
n=7 Participants
|
987 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
192 Participants
n=5 Participants
|
219 Participants
n=7 Participants
|
411 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
12 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
114 Participants
n=5 Participants
|
94 Participants
n=7 Participants
|
208 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
538 Participants
n=5 Participants
|
589 Participants
n=7 Participants
|
1127 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
681 participants
n=5 Participants
|
717 participants
n=7 Participants
|
1398 participants
n=5 Participants
|
|
Baseline HAM-D17
|
21.1 units on a scale
STANDARD_DEVIATION 4.20 • n=5 Participants
|
21.4 units on a scale
STANDARD_DEVIATION 4.22 • n=7 Participants
|
21.3 units on a scale
STANDARD_DEVIATION 4.21 • n=5 Participants
|
PRIMARY outcome
Timeframe: from baseline to end of Week 8Population: Per-Protocol
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.
Outcome measures
| Measure |
Treatment As Usual
n=607 Participants
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.
|
GeneSight Psychotropic Tested
n=560 Participants
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.
|
|---|---|---|
|
Percent Change in the 17-item Hamilton Depression (HAM-D17) Score From Baseline to 8 Weeks
|
-24.39 percentage of change
Standard Error 1.22
|
-27.23 percentage of change
Standard Error 1.27
|
SECONDARY outcome
Timeframe: from baseline to end of Week 8Population: Intent-to-Treat
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.
Outcome measures
| Measure |
Treatment As Usual
n=621 Participants
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.
|
GeneSight Psychotropic Tested
n=677 Participants
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.
|
|---|---|---|
|
Percent Change in the 16-item Quick Inventory of Depression Symptomology (QIDS-C16) Score From Baseline to 8 Weeks
|
-35.107 percentage of change
Standard Error 1.189
|
-32.900 percentage of change
Standard Error 1.147
|
SECONDARY outcome
Timeframe: Week 8 visit infoPopulation: Per Protocol
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.
Outcome measures
| Measure |
Treatment As Usual
n=560 Participants
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.
|
GeneSight Psychotropic Tested
n=607 Participants
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.
|
|---|---|---|
|
Percentage of Responders at Week 8 for HAM-D17
|
26.00 percentage of subjects
|
19.92 percentage of subjects
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: week 8 visit infoPopulation: Per Protocol
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.
Outcome measures
| Measure |
Treatment As Usual
n=560 Participants
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.
|
GeneSight Psychotropic Tested
n=607 Participants
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.
|
|---|---|---|
|
Percentage of Remitters at Week 8 Defined as HAM-D17 ≤7 Each Treatment Group;
|
15.30 percentage of subjects
|
10.08 percentage of subjects
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to week 24 visitsPopulation: 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
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.
Outcome measures
| Measure |
Treatment As Usual
n=457 Participants
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.
|
GeneSight Psychotropic Tested
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.
|
|---|---|---|
|
Percent Change in the 17-item Hamilton Depression (HAM-D17) Score From Baseline to 24 Weeks
|
42.5 percentage of change
Standard Error 1.52
|
—
|
SECONDARY outcome
Timeframe: Week 8 visit infoPopulation: Intent-to-treat
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.
Outcome measures
| Measure |
Treatment As Usual
n=677 Participants
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.
|
GeneSight Psychotropic Tested
n=621 Participants
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.
|
|---|---|---|
|
Percentage of Responders at Week 8 for QIDS-C16
|
34.14 percentage of subjects
|
31.36 percentage of subjects
|
SECONDARY outcome
Timeframe: Week 8 visit infoPopulation: Intent-to-treat
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.
Outcome measures
| Measure |
Treatment As Usual
n=676 Participants
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.
|
GeneSight Psychotropic Tested
n=620 Participants
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.
|
|---|---|---|
|
Percentage of Responders at Week 8 for PHQ-9
|
31.63 percentage of subjects
|
39.74 percentage of subjects
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: week 8 visit infoPopulation: Intent-to-treat
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.
Outcome measures
| Measure |
Treatment As Usual
n=677 Participants
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.
|
GeneSight Psychotropic Tested
n=621 Participants
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.
|
|---|---|---|
|
Percentage of Remitters at Week 8 Defined as QIDS-C16 ≤ 5 in Each Treatment Group
|
15.62 percentage of subjects
|
20.89 percentage of subjects
|
SECONDARY outcome
Timeframe: week 8 visit infoPopulation: Intent-to-treat
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.
Outcome measures
| Measure |
Treatment As Usual
n=677 Participants
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.
|
GeneSight Psychotropic Tested
n=620 Participants
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.
|
|---|---|---|
|
Percentage of Remitters at Week 8 Defined as PHQ-9 <5 in Each Treatment Group
|
14.79 percentage of subjects
|
18.58 percentage of subjects
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to week 24 visit infoPopulation: Per Protocol
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.
Outcome measures
| Measure |
Treatment As Usual
n=457 Participants
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.
|
GeneSight Psychotropic Tested
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.
|
|---|---|---|
|
Percentage of Responders at Week 24 for HAM-D17 in the GeneSight Psychotropic Tested Treatment Group
|
44.3 percentage of subjects
|
—
|
SECONDARY outcome
Timeframe: Baseline to week 24 visit infoPopulation: Per Protocol
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.
Outcome measures
| Measure |
Treatment As Usual
n=457 Participants
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.
|
GeneSight Psychotropic Tested
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.
|
|---|---|---|
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Percentage of Remitters at Week 24 Defined as HAM-D17 ≤7 in the GeneSight Psychotropic Tested Treatment Group
|
31.1 percentage of subjects
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: week 12 to week 24The mean change in Generalized Anxiety Disorder 7-item (GAD-7) scale from week 12 to week 24
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline to week 8The mean change in Generalized Anxiety Disorder 7-item (GAD-7) scale from baseline to week 8
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline to week 12The mean change in Generalized Anxiety Disorder 7-item (GAD-7) scale from baseline to week 12
Outcome measures
Outcome data not reported
Adverse Events
GeneSight Psychotropic Tested
Treatment As Usual
Serious adverse events
| Measure |
GeneSight Psychotropic Tested
n=681 participants at risk
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.
|
Treatment As Usual
n=717 participants at risk
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.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.15%
1/681 • Number of events 1 • 8 weeks
|
0.00%
0/717 • 8 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.15%
1/681 • Number of events 1 • 8 weeks
|
0.00%
0/717 • 8 weeks
|
|
Gastrointestinal disorders
Gastrointestinal hemorrhage
|
0.00%
0/681 • 8 weeks
|
0.14%
1/717 • Number of events 1 • 8 weeks
|
|
Metabolism and nutrition disorders
transient hypoglycemia
|
0.15%
1/681 • Number of events 1 • 8 weeks
|
0.00%
0/717 • 8 weeks
|
|
General disorders
non cardiac chest pains
|
0.00%
0/681 • 8 weeks
|
0.14%
1/717 • Number of events 1 • 8 weeks
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place