CompletedNCT02109939GUIDEDUpdated Jan 14, 2020Results posted

Genomics Used to Improve DEpression Decisions

An interventional study of GeneSight Psychotropic in Major Depressive Disorder (MDD), sponsored by Assurex Health Inc.. Completed at 61 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-01-14.

Sponsored by Assurex Health Inc. · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 1,398
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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.

Read the detailed description

Major depressive disorder (MDD) is a highly prevalent (Hasin et al., 2005) mental disorder and a leading source of disease burden worldwide (Lopez et al., 2006). Epidemiological studies estimate 12-month and lifetime prevalence for MDD in the United States to be 5.3% and 13.2%, respectively (reviewed in Blanco et al., 2010). MDD is expected to be the second greatest cause of disability by 2020 and has been shown to cause significant morbidity, affecting people's ability to work, function in relationships, and engage in social activities. Moreover, MDD increases the risk of suicidal ideation, attempted suicide, and death by completed suicide.

Prospective longitudinal studies of patient samples show that MDD is a chronic illness, characterized by remitting and recurrent depressive episodes (Solomon et al., 1997; Mueller et al., 1999). A major depressive episode is characterized by a low mood or an inability to experience pleasure (anhedonia), or both, for more than 2 weeks, combined with several cognitive and vegetative symptoms and the occurrence of distress or impairment (reviewed in Rot et al., 2009). In the US, nearly 1 in 5 people will experience a major depressive episode at some point in their lives (reviewed in Rot et al., 2009). Drugs currently available to treat depression fall into the categories of those that have their main effect by increasing norepinephrine (NE) (the tricyclic or tetracyclic antidepressants [TCAs]), those that increase serotonin (5-HT) (the selective serotonin reuptake inhibitors [SSRIs]), and those that increase both NE and 5-HT (the monoamine oxidase inhibitors [MAOIs] and the serotonin and norepinephrine reuptake inhibitors [SNRIs]). While all antidepressants achieve similar levels of efficacy, treatment failures are relatively high ranging from 30 to 60% (Simpson and DePaulo). Additionally, many of these compounds are associated with significant adverse events (AEs).

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.

The clinical utility of GeneSight Psychotropic has been evaluated in three previous prospective trials. Hall-Flavin et al reported the results of an open-label pilot study (n = 44) comparing GeneSight guided treatment to treatment as usual (TAU) without the benefit of pharmacogenomic testing (2012). The GeneSight guided arm demonstrated a 30.8% improvement in HAM-D17 score by the end of the 8 week treatment period, compared to an 18.2% improvement in the TAU arm (p = 0.04). Results of the larger (n = 165) open-label trial (Hall-Flavin, et al 2013) mirrored these findings, demonstrating a 46.9% improvement in HAMD17 score in the GeneSight arm, compared to a 29.9% improvement in the TAU arm (p \< 0.0001). The third trial used a randomized, double-blind trial design (n = 51). Due to the small sample size, the trial was underpowered to detect a significant difference in improvement between the two arms (TAU and GeneSight). However, effect sizes of improvement reflected those seen in previous trials. The GeneSight group experienced a 30.8% improvement in HAMD17, compared to 20.7% in TAU. Odds ratios for response were calculated, showing that GeneSight-guided subjects had a 2.14 times greater likelihood of response compared to TAU subjects, which was similar to the 4.67 (smaller trial) and 2.06 (larger trial) odds ratios calculated for the other two studies.

Previous studies utilizing an open-label design have shown significant improvement in patient outcomes following use of the GeneSight test. However, although effect sizes were similar to those seen in the open-label studies, a small (n = 51) blinded, randomized controlled trial did not detect a statistically significant outcome. Therefore, the primary rationale for this trial is to replicate previous findings of improvement in clinical outcomes in subjects treated with the benefit of GeneSight testing utilizing a double-blind, randomized control trial (RCT) design.

It is expected that results from this trial will be used to inform guidelines for the use of pharmacogenomic testing for the treatment of major depressive disorder. Results may also be shared with regulatory bodies in the United States and abroad.

Conditions studied

Major Depressive Disorder (MDD)

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Keywords

MDD
Pharmacogenomic
Pharmacogenomic Testing
Pharmacogenomics
Genetic Testing
Genetics
Major Depressive Disorder
GeneSight
Assurex
AssureRx
Psychotropic
Randomized
Double Blind
Placebo Controlled

In context

Depressive Disorder

4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.

This study's enrollment of 1,398 is above the median of 80 across 3,999 interventional studies indexed under Depressive Disorder.

Browse Depressive Disorder studies →

Lead sponsor

Assurex Health Inc. is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

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.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Care provider, Outcomes assessor)
Enrollment: 1,398 participants (actual)

Study arms

Active comparator
GeneSight Psychotropic Tested
Subjects being tested with GeneSight Psychotropic
Genetic: GeneSight Psychotropic
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

Interventions

GeneticGeneSight 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.
Also known as: Assurex Health, GeneSight

What researchers measure

Primary outcomes

Percent Change in the 17-item Hamilton Depression (HAM-D17) Score From Baseline to 8 Weeks
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

Secondary outcomes

Percent Change in the 16-item Quick Inventory of Depression Symptomology (QIDS-C16) Score From Baseline to 8 Weeks
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
Percentage of Responders at Week 8 for HAM-D17
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
Percentage of Responders at Week 12 for HAM-D17
\*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
Percentage of Remitters at Week 12 Defined as HAM-D17 ≤7
\*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
Percentage of Remitters at Week 8 Defined as HAM-D17 ≤7 Each Treatment Group;
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
Time to Response/Remission of Depressive Symptoms Over 8 Weeks;
\*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
Percent Change in the 17-item Hamilton Depression (HAM-D17) Score From Baseline to 24 Weeks
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
Percentage of Responders at Week 8 for QIDS-C16
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
Percentage of Responders at Week 8 for PHQ-9
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
Percentage of Remitters at Week 12 Defined as QIDS-C16 ≤5
\*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
Percentage of Remitters at Week 12 Defined as PHQ-9 <5
\*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
Percentage of Remitters at Week 12 Defined as CGI-S ≤1
\*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
Percentage of Responders at Week 12 for QIDS-C16
\*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
Percentage of Responders at Week 12 for PHQ-9
\*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
Percentage of Responders at Week 12 for CGI-S
\*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
Percentage of Responders at Week 12 for CGI-I
\*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
Percentage of Responders at Week 12 for CGI-EI
\*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
Percentage of Remitters at Week 8 Defined as QIDS-C16 ≤ 5 in Each Treatment Group
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
Percentage of Remitters at Week 8 Defined as PHQ-9 <5 in Each Treatment Group
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
Time to Response/Remission of Depressive Symptoms Over 12 Weeks;
\*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
Percentage of Responders at Week 24 for HAM-D17 in the GeneSight Psychotropic Tested Treatment Group
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
Percentage of Remitters at Week 24 Defined as HAM-D17 ≤7 in the GeneSight Psychotropic Tested Treatment Group
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

Other outcomes

Generalized Anxiety Disorder 7-item (GAD-7) Scale
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
Generalized Anxiety Disorder 7-item (GAD-7) Scale
The mean change in Generalized Anxiety Disorder 7-item (GAD-7) scale from baseline to week 8
Time frame: baseline to week 8
Generalized Anxiety Disorder 7-item (GAD-7) Scale
The mean change in Generalized Anxiety Disorder 7-item (GAD-7) scale from baseline to week 12
Time frame: baseline to week 12

Results

Posted Jan 14, 2020

Participant flow

Participant flow — Overall Study
Milestone	GeneSight Psychotropic Tested	Treatment As Usual
Started	681	717
Completed	560	607
Not completed	121	110

Outcome measures

PrimaryPercent Change in the 17-item Hamilton Depression (HAM-D17) Score From Baseline to 8 Weeks

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
Reported as:: Least squares mean · percentage of change

Percent Change in the 17-item Hamilton Depression (HAM-D17) Score From Baseline to 8 Weeks
percentage of change	Treatment As Usual	GeneSight Psychotropic Tested
Percent Change in the 17-item Hamilton Depression (HAM-D17) Score From Baseline to 8 Weeks	-24.39 ± 1.22	-27.23 ± 1.27

Statistical analysis

Treatment As Usual vs GeneSight Psychotropic Tested · Mixed Models Analysis · p = 0.1070 · Mean difference (net): -2.836 · 95% CI -6.285 to 0.613Repeated Measures including week 4.

SecondaryPercent Change in the 16-item Quick Inventory of Depression Symptomology (QIDS-C16) Score From Baseline to 8 Weeks

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
Reported as:: Least squares mean · percentage of change

Percent Change in the 16-item Quick Inventory of Depression Symptomology (QIDS-C16) Score From Baseline to 8 Weeks
percentage of change	GeneSight Psychotropic Tested	Treatment As Usual
Percent Change in the 16-item Quick Inventory of Depression Symptomology (QIDS-C16) Score From Baseline to 8 Weeks	-35.107 ± 1.189	-32.900 ± 1.147

Statistical analysis

GeneSight Psychotropic Tested vs Treatment As Usual · Mixed Models Analysis · p = 0.1822 · Mean difference (net): -2.207 · 95% CI -5.450 to 1.036MMRM with week 4 data.

SecondaryPercentage of Responders at Week 8 for HAM-D17

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
Reported as:: Number · percentage of subjects

Percentage of Responders at Week 8 for HAM-D17
percentage of subjects	GeneSight Psychotropic Tested	Treatment As Usual
Percentage of Responders at Week 8 for HAM-D17	26.00	19.92

Statistical analysis

GeneSight Psychotropic Tested vs Treatment As Usual · Generalized linear mixed model · p = 0.0134 · Odds ratio (or): 1.41 · 95% CI 1.07 to 1.86The reported outcome measure is the estimated percentage from a generalized linear mixed model, not a simple count of subjects.

SecondaryPercentage of Responders at Week 12 for HAM-D17

\*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

Results for this outcome have not been posted.

SecondaryPercentage of Remitters at Week 12 Defined as HAM-D17 ≤7

Time frame:: week 12 visit info

Results for this outcome have not been posted.

SecondaryPercentage of Remitters at Week 8 Defined as HAM-D17 ≤7 Each Treatment Group;

Time frame:: week 8 visit info
Reported as:: Number · percentage of subjects

Percentage of Remitters at Week 8 Defined as HAM-D17 ≤7 Each Treatment Group;
percentage of subjects	GeneSight Psychotropic Tested	Treatment As Usual
Percentage of Remitters at Week 8 Defined as HAM-D17 ≤7 Each Treatment Group;	15.30	10.08

Statistical analysis

GeneSight Psychotropic Tested vs Treatment As Usual · Generalized linear mixed model · p = 0.0066 · Odds ratio (or): 1.61 · 95% CI 1.14 to 2.27The reported outcome measure is the estimated percentage from a generalized linear mixed model, not a simple count of subjects.

SecondaryTime to Response/Remission of Depressive Symptoms Over 8 Weeks;

Time frame:: week 4 and 8 visit info

Results for this outcome have not been posted.

SecondaryPercent Change in the 17-item Hamilton Depression (HAM-D17) Score From Baseline to 24 Weeks

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
Reported as:: Mean · percentage of change

Percent Change in the 17-item Hamilton Depression (HAM-D17) Score From Baseline to 24 Weeks
percentage of change	GeneSight Psychotropic Tested
Percent Change in the 17-item Hamilton Depression (HAM-D17) Score From Baseline to 24 Weeks	42.5 ± 1.52

SecondaryPercentage of Responders at Week 8 for QIDS-C16

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
Reported as:: Number · percentage of subjects

Percentage of Responders at Week 8 for QIDS-C16
percentage of subjects	GeneSight Psychotropic Tested	Treatment As Usual
Percentage of Responders at Week 8 for QIDS-C16	34.14	31.36

Statistical analysis

GeneSight Psychotropic Tested vs Treatment As Usual · Generalized linear mixed model. · p = 0.2852 · Odds ratio (or): 1.13 · 95% CI 0.90 to 1.43The reported outcome measure is the estimated percentage from a generalized linear mixed model, not a simple count of subjects.

SecondaryPercentage of Responders at Week 8 for PHQ-9

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
Reported as:: Number · percentage of subjects

Percentage of Responders at Week 8 for PHQ-9
percentage of subjects	Treatment As Usual	GeneSight Psychotropic Tested
Percentage of Responders at Week 8 for PHQ-9	31.63	39.74

Statistical analysis

Treatment As Usual vs GeneSight Psychotropic Tested · Generalized linear mixed model · p = 0.0023 · Odds ratio (or): 1.43 · 95% CI 1.14 to 1.79The reported outcome measure is the estimated percentage from a generalized linear mixed model, not a simple count of subjects.

SecondaryPercentage of Remitters at Week 12 Defined as QIDS-C16 ≤5

Time frame:: week 12 visit info

Results for this outcome have not been posted.

SecondaryPercentage of Remitters at Week 12 Defined as PHQ-9 <5

Time frame:: week 12 visit info

Results for this outcome have not been posted.

SecondaryPercentage of Remitters at Week 12 Defined as CGI-S ≤1

Time frame:: week 12 visit info

Results for this outcome have not been posted.

SecondaryPercentage of Responders at Week 12 for QIDS-C16

Time frame:: Week 12 visit info

Results for this outcome have not been posted.

SecondaryPercentage of Responders at Week 12 for PHQ-9

Time frame:: Week 12 visit info

Results for this outcome have not been posted.

SecondaryPercentage of Responders at Week 12 for CGI-S

Time frame:: Week 12 visit info

Results for this outcome have not been posted.

SecondaryPercentage of Responders at Week 12 for CGI-I

Time frame:: Week 12 visit info

Results for this outcome have not been posted.

SecondaryPercentage of Responders at Week 12 for CGI-EI

Time frame:: Week 12 visit info

Results for this outcome have not been posted.

SecondaryPercentage of Remitters at Week 8 Defined as QIDS-C16 ≤ 5 in Each Treatment Group

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
Reported as:: Number · percentage of subjects

Percentage of Remitters at Week 8 Defined as QIDS-C16 ≤ 5 in Each Treatment Group
percentage of subjects	Treatment As Usual	GeneSight Psychotropic Tested
Percentage of Remitters at Week 8 Defined as QIDS-C16 ≤ 5 in Each Treatment Group	15.62	20.89

Statistical analysis

Treatment As Usual vs GeneSight Psychotropic Tested · Generalized linear mixed model · p = 0.0140 · Odds ratio (or): 1.43 · 95% CI 1.07 to 1.89The reported outcome measure is the estimated percentage from a generalized linear mixed model, not a simple count of subjects.

SecondaryPercentage of Remitters at Week 8 Defined as PHQ-9 <5 in Each Treatment Group

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
Reported as:: Number · percentage of subjects

Percentage of Remitters at Week 8 Defined as PHQ-9 <5 in Each Treatment Group
percentage of subjects	Treatment As Usual	GeneSight Psychotropic Tested
Percentage of Remitters at Week 8 Defined as PHQ-9 <5 in Each Treatment Group	14.79	18.58

Statistical analysis

Treatment As Usual vs GeneSight Psychotropic Tested · Generalized linear mixed model · p = 0.0663 · Odds ratio (or): 1.31 · 95% CI 0.98 to 1.76The reported outcome measure is the estimated percentage from a generalized linear mixed model, not a simple count of subjects.

SecondaryTime to Response/Remission of Depressive Symptoms Over 12 Weeks;

\*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

Results for this outcome have not been posted.

SecondaryPercentage of Responders at Week 24 for HAM-D17 in the GeneSight Psychotropic Tested Treatment Group

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
Reported as:: Number · percentage of subjects

Percentage of Responders at Week 24 for HAM-D17 in the GeneSight Psychotropic Tested Treatment Group
percentage of subjects	GeneSight Psychotropic Tested
Percentage of Responders at Week 24 for HAM-D17 in the GeneSight Psychotropic Tested Treatment Group	44.3

SecondaryPercentage of Remitters at Week 24 Defined as HAM-D17 ≤7 in the GeneSight Psychotropic Tested Treatment Group

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
Reported as:: Number · percentage of subjects

Percentage of Remitters at Week 24 Defined as HAM-D17 ≤7 in the GeneSight Psychotropic Tested Treatment Group
percentage of subjects	GeneSight Psychotropic Tested
Percentage of Remitters at Week 24 Defined as HAM-D17 ≤7 in the GeneSight Psychotropic Tested Treatment Group	31.1

Other pre-specifiedGeneralized Anxiety Disorder 7-item (GAD-7) Scale

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

Results for this outcome have not been posted.

Other pre-specifiedGeneralized Anxiety Disorder 7-item (GAD-7) Scale

The mean change in Generalized Anxiety Disorder 7-item (GAD-7) scale from baseline to week 8

Time frame:: baseline to week 8

Results for this outcome have not been posted.

Other pre-specifiedGeneralized Anxiety Disorder 7-item (GAD-7) Scale

The mean change in Generalized Anxiety Disorder 7-item (GAD-7) scale from baseline to week 12

Time frame:: baseline to week 12

Results for this outcome have not been posted.

Adverse events

Collected over 8 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
GeneSight Psychotropic Tested	0/681 (0%)	3/681 (0.4%)	0/681 (0%)
Treatment As Usual	0/717 (0%)	2/717 (0.3%)	0/717 (0%)

Most frequent serious events

Most frequent serious events
Event	GeneSight Psychotropic Tested	Treatment As Usual
Pulmonary embolismRespiratory, thoracic and mediastinal disorders	1/681	0/717
Muscle twitchingMusculoskeletal and connective tissue disorders	1/681	0/717
transient hypoglycemiaMetabolism and nutrition disorders	1/681	0/717
Gastrointestinal hemorrhageGastrointestinal disorders	0/681	1/717
non cardiac chest painsGeneral disorders	0/681	1/717

Baseline characteristics

Per Protocol Population at Baseline

Age, Categorical
Age, Categorical(Participants)	GeneSight Psychotropic Tested	Treatment As Usual	Total
<=18 years	0	0	0
Between 18 and 65 years	597	616	1213
>=65 years	84	101	185

Age, Continuous
Age, Continuous(years)	GeneSight Psychotropic Tested	Treatment As Usual	Total
Mean	46.9 ± 14.5	48.0 ± 50.0	47.5 ± 14.5

Sex: Female, Male
Sex: Female, Male(Participants)	GeneSight Psychotropic Tested	Treatment As Usual	Total
Female	489	498	987
Male	192	219	411

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	GeneSight Psychotropic Tested	Treatment As Usual	Total
American Indian or Alaska Native	5	3	8
Asian	12	17	29
Native Hawaiian or Other Pacific Islander	1	0	1
Black or African American	114	94	208
White	538	589	1127
More than one race	11	14	25
Unknown or Not Reported	0	0	0

Region of Enrollment
Region of Enrollment(participants)	GeneSight Psychotropic Tested	Treatment As Usual	Total
United States	681	717	1398

Baseline HAM-D17
Baseline HAM-D17(units on a scale)	GeneSight Psychotropic Tested	Treatment As Usual	Total
Mean	21.1 ± 4.20	21.4 ± 4.22	21.3 ± 4.21

Study locations

61 sites

Birmingham Psychiatry Pharmaceutical Studies
Birmingham, Alabama 35226, United States
University of Alabama at Birmingham
Birmingham, Alabama 35233, United States
CiTrials
Bellflower, California 90706, United States
Catalina Research Institute
Chino, California 91710, United States
CiTrials
Costa Mesa, California 92705, United States
Synergy Research Center
Escondido, California 92025, United States
Pharmacology Research Institute
Los Alamitos, California 90720, United States
North County Research
Oceanside, California 92056, United States
CiTrials
Riverside, California 92506, United States
Stanford School of Medicine
Stanford, California 94304, United States
Viking Clinical Research
Temecula, California 92591, United States
Elite Clinical Trials, Inc
Wildomar, California 92595, United States
MCB Clinical Research Centers, LLC
Colorado Springs, Colorado 80910, United States
Howard University Hospital Mental Health Clinic
Washington, District of Columbia 20060, United States
Sarkis Clinical Trials
Gainesville, Florida 32607, United States
Clinical Neuroscience Solutions Healthcare
Jacksonville, Florida 32256, United States
Clinical Neuroscience Solutions
Orlando, Florida 32801, United States
Clinical Research Trials of Florida, Inc
Tampa, Florida 33607, United States
Stedman Clinical Trials
Tampa, Florida 33613, United States
Janus Center For Psychiatric Research
West Palm Beach, Florida 33407, United States
Atlanta Institute of Medicine and Research
Atlanta, Georgia 30328, United States
Mood and Anxiety Program at Emory University
Atlanta, Georgia 30329, United States
Meridian Clinical Research
Savannah, Georgia 31406, United States
Carman Research
Smyrna, Georgia 30080, United States
Rush University Medical Center
Chicago, Illinois 60612, United States
Behavioral Healthcare Associates
Schaumburg, Illinois 60194, United States
The Institute of Psychiatric Research
Indianapolis, Indiana 46202, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa 52242, United States
Kansas University Medical Center- Clinical Trials Unit
Wichita, Kansas 67214, United States
Pharmasite Research
Baltimore, Maryland 21208, United States
Johns Hopkins Hospital
Baltimore, Maryland 21224, United States
Geriatric Outpatient Unit- McLean Hospital
Belmont, Massachusetts 02478, United States
Boston Clinical Trials
Boston, Massachusetts 02131, United States
UMASS Center for Psychopharmacologic Research and Treatment
Worcester, Massachusetts 01655, United States
University of Michigan
Ann Arbor, Michigan 48109, United States
University of Minnesota
Minneapolis, Minnesota 55454, United States
Washington University School of Medicine
Saint Louis, Missouri 63110, United States
PsychCare Consultants Research
Saint Louis, Missouri 63128, United States
Meridian Clinical Research
Bellevue, Nebraska 68005, United States
Premier Psychiatric Research Institute, LLC
Lincoln, Nebraska 68526, United States
United Medical Research Associates
Binghamton, New York 13901, United States
Integrative Clinical Trials, LLC
Brooklyn, New York 11229, United States
SPRI Clinical Trials
Brooklyn, New York 11235, United States
Eastside Comprehensive Medical Center, LLC
New York, New York 10021, United States
Finger Lakes Clinical Research
Rochester, New York 14618, United States
University of Cincinnati Health
Cincinnati, Ohio 45267, United States
Cleveland Clinic
Cleveland, Ohio 44120, United States
Ohio State University Department of Psychiatry
Columbus, Ohio 43210, United States
Midwest Clinical Research Center
Dayton, Ohio 45417, United States
Oklahoma Clinical Research Center
Oklahoma City, Oklahoma 73112, United States
Summit Research Network
Portland, Oregon 97210, United States
Suburban Research Associates
Media, Pennsylvania 19063, United States
Mood and Anxiety Disorders Treatment and Research
Philadelphia, Pennsylvania 19104, United States
Lincoln Research
Lincoln, Rhode Island 02865, United States
Clinical Neuroscience Solutions
Memphis, Tennessee 38119, United States
University of Texas Southwestern Medical Center
Dallas, Texas 76034, United States
Baylor College of Medicine
Houston, Texas 77030, United States
Alliance Research Group
Richmond, Virginia 20230, United States
Northwest Clinical Research Center
Bellevue, Washington 98007, United States
Summit Research Network
Seattle, Washington 98104, United States
Frontier Institute
Spokane, Washington 99204, United States

References and documents

Publications

Dunlop BW, Parikh SV, Rothschild AJ, Thase ME, DeBattista C, Conway CR, Forester BP, Mondimore FM, Shelton RC, Macaluso M, Logan J, Traxler P, Li J, Johnson H, Greden JF. Comparing sensitivity to change using the 6-item versus the 17-item Hamilton depression rating scale in the GUIDED randomized controlled trial. BMC Psychiatry. 2019 Dec 27;19(1):420. doi: 10.1186/s12888-019-2410-2. PubMed 31881956 ↗
Thase ME, Parikh SV, Rothschild AJ, Dunlop BW, DeBattista C, Conway CR, Forester BP, Mondimore FM, Shelton RC, Macaluso M, Li J, Brown K, Jablonski MR, Greden JF. Impact of Pharmacogenomics on Clinical Outcomes for Patients Taking Medications With Gene-Drug Interactions in a Randomized Controlled Trial. J Clin Psychiatry. 2019 Oct 31;80(6):19m12910. doi: 10.4088/JCP.19m12910. PubMed 31721487 ↗
Greden JF, Parikh SV, Rothschild AJ, Thase ME, Dunlop BW, DeBattista C, Conway CR, Forester BP, Mondimore FM, Shelton RC, Macaluso M, Li J, Brown K, Gilbert A, Burns L, Jablonski MR, Dechairo B. Impact of pharmacogenomics on clinical outcomes in major depressive disorder in the GUIDED trial: A large, patient- and rater-blinded, randomized, controlled study. J Psychiatr Res. 2019 Apr;111:59-67. doi: 10.1016/j.jpsychires.2019.01.003. Epub 2019 Jan 4. PubMed 30677646 ↗

Study documents

Study protocol · Apr 21, 2015
Statistical analysis plan · Aug 17, 2016

Documents are hosted by the registry — open the source record to download them.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 14, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02109939
Lead sponsor: Assurex Health Inc.
Collaborators: University of Michigan
Responsible party: Sponsor
First posted: Apr 10, 2014
Start date: Apr 2014
Primary completion: Apr 20, 2017
Completion: Jul 31, 2017
Results posted: Jan 14, 2020
Last update: Jan 14, 2020

Study contacts

John Greden, Ph.D

principal investigator · University of Michigan

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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