Genomics Used to Improve DEpression Decisions (GUIDED)

• ClinicalTrials.gov Identifier: NCT02109939
• Recruitment Status: Completed
• First Posted: April 10, 2014
• Results First Posted: January 14, 2020
• Last Update Posted: January 14, 2020
• Sponsor: Assurex Health Inc.
• Collaborator: University of Michigan
• Information provided by (Responsible Party): Assurex Health Inc.

Study Description

Brief Summary:

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

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

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 Design

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

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Percent Change in the 16-item Quick Inventory of Depression Symptomology (QIDS-C16) Score From Baseline to 8 Weeks [ Time Frame: from baseline to end of Week 8 ]
   Mean percent change in the 16-item Quick Inventory of Depression Symptomology (QIDS-C16) score from baseline to end of Week 8 of the study. Scores range from 0 to 27 with lower scores being better outcomes. Percent change is defined as (week 8 score - baseline score) / (baseline score) x 100.
2. Percentage of Responders at Week 8 for HAM-D17 [ Time Frame: Week 8 visit info ]
   Adjusted percentage of responders at Week 8 in each treatment group on the 17-item Hamilton Depression Rating Scale (HAM-D17). A responder is defined as a participant with at least a 50% decrease from baseline in total scale score. Scores range from 0 to 50, and lower scores are better outcomes.
3. Percentage of Responders at Week 12 for HAM-D17 [ Time Frame: Week 12 visit info ]
   *Comment*: For patients in TAU, clinicians were blinded to the pharmacogenomic test result until after completion of the week 8 visit. Because unblinding might have occurred for some patients prior to week 12 assessments, data collected at week 12 were no longer considered blinded and are not analyzed or reported.
4. Percentage of Remitters at Week 12 Defined as HAM-D17 ≤7 [ Time Frame: week 12 visit info ]
   *Comment*: For patients in TAU, clinicians were blinded to the pharmacogenomic test result until after completion of the week 8 visit. Because unblinding might have occurred for some patients prior to week 12 assessments, data collected at week 12 were no longer considered blinded and are not analyzed or reported.
5. Percentage of Remitters at Week 8 Defined as HAM-D17 ≤7 Each Treatment Group; [ Time Frame: week 8 visit info ]
   Adjusted percentage of remitters at Week 8 defined as a score ≤7 in the 17-item Hamilton Depression Rating Scale (HAM-D17) in each treatment group. Scores range from 0 to 50, and lower scores are better outcomes.
6. Time to Response/Remission of Depressive Symptoms Over 8 Weeks; [ Time Frame: week 4 and 8 visit info ]
   *Comment*: Time to response/remission is not an outcome measure that can accurately be reported from the way the data was collected. As specified in the updated SAP before the blind was broken, this was not analyzed or reported.
7. Percent Change in the 17-item Hamilton Depression (HAM-D17) Score From Baseline to 24 Weeks [ Time Frame: Baseline to week 24 visits ]
   Evaluate the impact of GeneSight Psychotropic on response to psychotropic treatment as judged by the mean percent change in the 17-item Hamilton Depression (HAM-D17) score from baseline to end of Week 24 of the study. Scores range from 0 to 50, and lower scores are better outcomes. Percent change is defined as (week 24 score -baseline score) / (baseline score) x 100.
8. Percentage of Responders at Week 8 for QIDS-C16 [ Time Frame: Week 8 visit info ]
   Adjusted percentage of responders at Week 8 in each treatment group on the 16-item Quick Inventory of Depression Symptomology (QIDS-C16). A responder is defined as a participant with at least 50% decrease from baseline in total scale score. Scores range from 0 to 27 with lower scores being better outcomes.
9. Percentage of Responders at Week 8 for PHQ-9 [ Time Frame: Week 8 visit info ]
   Adjusted percentage of responders at Week 8 in each treatment group on the 9-item Patient Health Questionnaire (PHQ-9). A responder is defined as a participant with at least 50% decrease from baseline in total scale score. Scores range from 0 to 27 with lower scores being better outcomes.
10. Percentage of Remitters at Week 12 Defined as QIDS-C16 ≤5 [ Time Frame: week 12 visit info ]
    *Comment*: For patients in TAU, clinicians were blinded to the pharmacogenomic test result until after completion of the week 8 visit. Because unblinding might have occurred for some patients prior to week 12 assessments, data collected at week 12 were no longer considered blinded and are not analyzed or reported.
11. Percentage of Remitters at Week 12 Defined as PHQ-9 <5 [ Time Frame: week 12 visit info ]
    *Comment*: For patients in TAU, clinicians were blinded to the pharmacogenomic test result until after completion of the week 8 visit. Because unblinding might have occurred for some patients prior to week 12 assessments, data collected at week 12 were no longer considered blinded and are not analyzed or reported.
12. Percentage of Remitters at Week 12 Defined as CGI-S ≤1 [ Time Frame: week 12 visit info ]
    *Comment*: For patients in TAU, clinicians were blinded to the pharmacogenomic test result until after completion of the week 8 visit. Because unblinding might have occurred for some patients prior to week 12 assessments, data collected at week 12 were no longer considered blinded and are not analyzed or reported.
13. Percentage of Responders at Week 12 for QIDS-C16 [ Time Frame: Week 12 visit info ]
    *Comment*: For patients in TAU, clinicians were blinded to the pharmacogenomic test result until after completion of the week 8 visit. Because unblinding might have occurred for some patients prior to week 12 assessments, data collected at week 12 were no longer considered blinded and are not analyzed or reported.
14. Percentage of Responders at Week 12 for PHQ-9 [ Time Frame: Week 12 visit info ]
    *Comment*: For patients in TAU, clinicians were blinded to the pharmacogenomic test result until after completion of the week 8 visit. Because unblinding might have occurred for some patients prior to week 12 assessments, data collected at week 12 were no longer considered blinded and are not analyzed or reported.
15. Percentage of Responders at Week 12 for CGI-S [ Time Frame: Week 12 visit info ]
    *Comment*: For patients in TAU, clinicians were blinded to the pharmacogenomic test result until after completion of the week 8 visit. Because unblinding might have occurred for some patients prior to week 12 assessments, data collected at week 12 were no longer considered blinded and are not analyzed or reported.
16. Percentage of Responders at Week 12 for CGI-I [ Time Frame: Week 12 visit info ]
    *Comment*: For patients in TAU, clinicians were blinded to the pharmacogenomic test result until after completion of the week 8 visit. Because unblinding might have occurred for some patients prior to week 12 assessments, data collected at week 12 were no longer considered blinded and are not analyzed or reported.
17. Percentage of Responders at Week 12 for CGI-EI [ Time Frame: Week 12 visit info ]
    *Comment*: For patients in TAU, clinicians were blinded to the pharmacogenomic test result until after completion of the week 8 visit. Because unblinding might have occurred for some patients prior to week 12 assessments, data collected at week 12 were no longer considered blinded and are not analyzed or reported.
18. Percentage of Remitters at Week 8 Defined as QIDS-C16 ≤ 5 in Each Treatment Group [ Time Frame: week 8 visit info ]
    Adjusted percentage of remitters at Week 8 in the 16-item Quick Inventory of Depression Symptomology (QIDS-C16) in each treatment group. A remitter is defined as a subject with a score ≤ 5. Scores range from 0 to 27 with lower scores being better outcomes.
19. Percentage of Remitters at Week 8 Defined as PHQ-9 <5 in Each Treatment Group [ Time Frame: week 8 visit info ]
    Adjusted percentage of remitters at Week 8 in each treatment group on the 9-item Patient Health Questionnaire (PHQ-9). A remitter is defined as a participant with score <5 on the PHQ-9. Scores range from 0 to 27 with lower scores being better outcomes.
20. Time to Response/Remission of Depressive Symptoms Over 12 Weeks; [ Time Frame: week 4, 8, and 12 visit info ]
    *Comment*: Time to response/remission is not an outcome measure that can accurately be reported from the way the data was collected. As specified in the updated SAP before the blind was broken, this was not analyzed and reported. Additionally, for patients in TAU, clinicians were blinded to the pharmacogenomic test result until after completion of the week 8 visit. Because unblinding may have occurred prior to week 12 assessments, data collected at week 12 were considered unblinded and are not reported.
21. Percentage of Responders at Week 24 for HAM-D17 in the GeneSight Psychotropic Tested Treatment Group [ Time Frame: Baseline to week 24 visit info ]
    Adjusted percentage of responders at Week 24 in the GeneSight Psychotropic Tested treatment group on the 17-item Hamilton Depression Rating Scale (HAM-D17). A responder is defined as a participant with at least a 50% decrease from baseline in total scale score. Scores range from 0 to 50, and lower scores are better outcomes.
22. Percentage of Remitters at Week 24 Defined as HAM-D17 ≤7 in the GeneSight Psychotropic Tested Treatment Group [ Time Frame: Baseline to week 24 visit info ]

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

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

Other Outcome Measures:

1. Generalized Anxiety Disorder 7-item (GAD-7) Scale [ Time Frame: week 12 to week 24 ]
   The mean change in Generalized Anxiety Disorder 7-item (GAD-7) scale from week 12 to week 24
2. Generalized Anxiety Disorder 7-item (GAD-7) Scale [ Time Frame: baseline to week 8 ]
   The mean change in Generalized Anxiety Disorder 7-item (GAD-7) scale from baseline to week 8
3. Generalized Anxiety Disorder 7-item (GAD-7) Scale [ Time Frame: baseline to week 12 ]
   The mean change in Generalized Anxiety Disorder 7-item (GAD-7) scale from baseline to week 12

Eligibility Criteria

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

• Patients with a current Axis I diagnosis of:

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

Contacts and Locations

Locations

United States, Alabama

Birmingham Psychiatry Pharmaceutical Studies

Birmingham, Alabama, United States, 35226

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35233

United States, California

CiTrials

Bellflower, California, United States, 90706

Catalina Research Institute

Chino, California, United States, 91710

CiTrials

Costa Mesa, California, United States, 92705

Synergy Research Center

Escondido, California, United States, 92025

Pharmacology Research Institute

Los Alamitos, California, United States, 90720

North County Research

Oceanside, California, United States, 92056

CiTrials

Riverside, California, United States, 92506

Stanford School of Medicine

Stanford, California, United States, 94304

Viking Clinical Research

Temecula, California, United States, 92591

Elite Clinical Trials, Inc

Wildomar, California, United States, 92595

United States, Colorado

MCB Clinical Research Centers, LLC

Colorado Springs, Colorado, United States, 80910

United States, District of Columbia

Howard University Hospital Mental Health Clinic

Washington, District of Columbia, United States, 20060

United States, Florida

Sarkis Clinical Trials

Gainesville, Florida, United States, 32607

Clinical Neuroscience Solutions Healthcare

Jacksonville, Florida, United States, 32256

Clinical Neuroscience Solutions

Orlando, Florida, United States, 32801

Clinical Research Trials of Florida, Inc

Tampa, Florida, United States, 33607

Stedman Clinical Trials

Tampa, Florida, United States, 33613

Janus Center For Psychiatric Research

West Palm Beach, Florida, United States, 33407

United States, Georgia

Atlanta Institute of Medicine and Research

Atlanta, Georgia, United States, 30328

Mood and Anxiety Program at Emory University

Atlanta, Georgia, United States, 30329

Meridian Clinical Research

Savannah, Georgia, United States, 31406

Carman Research

Smyrna, Georgia, United States, 30080

United States, Illinois

Rush University Medical Center

Chicago, Illinois, United States, 60612

Behavioral Healthcare Associates

Schaumburg, Illinois, United States, 60194

United States, Indiana

The Institute of Psychiatric Research

Indianapolis, Indiana, United States, 46202

United States, Iowa

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States, 52242

United States, Kansas

Kansas University Medical Center- Clinical Trials Unit

Wichita, Kansas, United States, 67214

United States, Maryland

Pharmasite Research

Baltimore, Maryland, United States, 21208

Johns Hopkins Hospital

Baltimore, Maryland, United States, 21224

United States, Massachusetts

Geriatric Outpatient Unit- McLean Hospital

Belmont, Massachusetts, United States, 02478

Boston Clinical Trials

Boston, Massachusetts, United States, 02131

UMASS Center for Psychopharmacologic Research and Treatment

Worcester, Massachusetts, United States, 01655

United States, Michigan

University of Michigan

Ann Arbor, Michigan, United States, 48109

United States, Minnesota

University of Minnesota

Minneapolis, Minnesota, United States, 55454

United States, Missouri

Washington University School of Medicine

Saint Louis, Missouri, United States, 63110

PsychCare Consultants Research

Saint Louis, Missouri, United States, 63128

United States, Nebraska

Meridian Clinical Research

Bellevue, Nebraska, United States, 68005

Premier Psychiatric Research Institute, LLC

Lincoln, Nebraska, United States, 68526

United States, New York

United Medical Research Associates

Binghamton, New York, United States, 13901

Integrative Clinical Trials, LLC

Brooklyn, New York, United States, 11229

SPRI Clinical Trials

Brooklyn, New York, United States, 11235

Eastside Comprehensive Medical Center, LLC

New York, New York, United States, 10021

Finger Lakes Clinical Research

Rochester, New York, United States, 14618

United States, Ohio

University of Cincinnati Health

Cincinnati, Ohio, United States, 45267

Cleveland Clinic

Cleveland, Ohio, United States, 44120

Ohio State University Department of Psychiatry

Columbus, Ohio, United States, 43210

Midwest Clinical Research Center

Dayton, Ohio, United States, 45417

United States, Oklahoma

Oklahoma Clinical Research Center

Oklahoma City, Oklahoma, United States, 73112

United States, Oregon

Summit Research Network

Portland, Oregon, United States, 97210

United States, Pennsylvania

Suburban Research Associates

Media, Pennsylvania, United States, 19063

Mood and Anxiety Disorders Treatment and Research

Philadelphia, Pennsylvania, United States, 19104

United States, Rhode Island

Lincoln Research

Lincoln, Rhode Island, United States, 02865

United States, Tennessee

Clinical Neuroscience Solutions

Memphis, Tennessee, United States, 38119

United States, Texas

University of Texas Southwestern Medical Center

Dallas, Texas, United States, 76034

Baylor College of Medicine

Houston, Texas, United States, 77030

United States, Virginia

Alliance Research Group

Richmond, Virginia, United States, 20230

United States, Washington

Northwest Clinical Research Center

Bellevue, Washington, United States, 98007

Summit Research Network

Seattle, Washington, United States, 98104

Frontier Institute

Spokane, Washington, United States, 99204

Sponsors and Collaborators

Assurex Health Inc.

University of Michigan

Investigators

• Principal Investigator: John Greden, Ph.D; University of Michigan

  Study Documents (Full-Text)

Documents provided by Assurex Health Inc.:

Study Protocol  [PDF] April 21, 2015

Statistical Analysis Plan  [PDF] August 17, 2016

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Assurex Health Inc.
• ClinicalTrials.gov Identifier: NCT02109939
• Other Study ID Numbers: ARX1006
• First Posted: April 10, 2014
• Results First Posted: January 14, 2020
• Last Update Posted: January 14, 2020
• Last Verified: January 2020

Keywords provided by Assurex Health Inc.:

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

Additional relevant MeSH terms:

Depressive Disorder; Depression; Depressive Disorder, Major; Mood Disorders; Mental Disorders; Behavioral Symptoms; Psychotropic Drugs