Genomics Used to Improve DEpression Decisions (GUIDED)

12 Week, Randomized, Double-Blind, Controlled Evaluation Followed by an Open Label 12-Week Follow-up Period of the Impact of GeneSight Psychotropic on Response to Psychotropic Treatment in Outpatients Suffering From A Major Depressive Disorder (MDD) Having Had- Within the Current Episode- An Inadequate Response to at Least One Medication Included in GeneSight Psychotropic

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.

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder (MDD)
• Intervention / Treatment: Genetic: GeneSight Psychotropic

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.

• Study Type: Interventional
• Enrollment (Actual): 1398
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

• Patients with a current Axis I diagnosis of:

  1. Delirium
  2. Dementia
  3. Amnestic and other cognitive disorder
  4. Schizophrenia or other psychotic disorder;
• Patients having experienced hallucinations, delusions, or any psychotic symptomatology within the current depressive episode or during prior depressive episodes;
• Patient is currently in an inpatient facility;
• Patients with a history of hypothyroidism unless taking a stable dose of thyroid medication and asymptomatic or euthyroid for 6 months;
• Patients who meet DSM-IV-TR criteria for any significant current substance use disorder;
• Patients with significant unstable medical condition; life threatening disease; hepatic insufficiency (3X ULN for AST and/or ALT); liver transplant recipient; cirrhosis of the liver; need for therapies that may obscure the results of treatment and/or of the study; malignancy (except basal cell carcinoma) and/or chemotherapy within 1 year prior to screening; malignancy more than 1 year prior to screening must have been local and without metastasis and/or recurrence, and if treated with chemotherapy, without nervous system complications;
• Participation in another clinical trial within 30 days of the screening visit;
• Anticipated inability to attend scheduled study visits;
• Patients who in the judgment of the Investigator may be unreliable or uncooperative with the evaluation procedure outlined in this protocol;
• Patients with a history of prior pharmacogenomic testing;
• Any change in psychotropic medication (including change in dosage) between screening and randomization;
• Patients receiving ECT, DBS or TMS treatment (should a Subject receive any of these treatments they must be discontinued from the study);
• Patients who are known to be pregnant or lactating;
• Patients with a history of gastric bypass surgery.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: GeneSight Psychotropic Tested; Subjects being tested with GeneSight Psychotropic	Genetic: GeneSight Psychotropic; The GeneSight Psychotropic product is a pharmacogenomic decision support tool that helps clinicians to make informed, evidence-based decisions about proper drug selection, based on the testing for clinically important genetic variants in multiple pharmacokinetic and pharmacodynamic genes that affect a patient's ability to tolerate or respond to medications. The GeneSight Psychotropic product contains the most commonly prescribed antidepressant and antipsychotic medications, including a full representation of the SSRI and SNRI drug classes. tricyclic antidepressants, an MAOI, and typical and atypical antipsychotics are also represented.; Other Names: Assurex Health; GeneSight
Placebo Comparator: Treatment As Usual; This group of subjects will not see their GeneSIght results or know whether or not they are in either arm until after week 12.	Genetic: GeneSight Psychotropic; The GeneSight Psychotropic product is a pharmacogenomic decision support tool that helps clinicians to make informed, evidence-based decisions about proper drug selection, based on the testing for clinically important genetic variants in multiple pharmacokinetic and pharmacodynamic genes that affect a patient's ability to tolerate or respond to medications. The GeneSight Psychotropic product contains the most commonly prescribed antidepressant and antipsychotic medications, including a full representation of the SSRI and SNRI drug classes. tricyclic antidepressants, an MAOI, and typical and atypical antipsychotics are also represented.; Other Names: Assurex Health; GeneSight

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	from baseline to end of Week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	Baseline to week 24 visit info

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	baseline to week 12

Collaborators and Investigators

• Sponsor: Assurex Health Inc.
• Collaborators: University of Michigan
• Investigators: Principal Investigator: John Greden, Ph.D, University of Michigan

Publications and helpful links

General 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2014
• Primary Completion (Actual): April 20, 2017
• Study Completion (Actual): July 31, 2017

Study Registration Dates

• First Submitted: April 4, 2014
• First Submitted That Met QC Criteria: April 9, 2014
• First Posted (Estimate): April 10, 2014

Study Record Updates

• Last Update Posted (Actual): January 14, 2020
• Last Update Submitted That Met QC Criteria: January 13, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Genetics; MDD; Randomized; Major Depressive Disorder; Pharmacogenomic; Pharmacogenomic Testing; Pharmacogenomics; Genetic Testing; GeneSight; Assurex; AssureRx; Psychotropic; Double Blind; Placebo Controlled
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major; Psychotropic Drugs
• Other Study ID Numbers: ARX1006

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No