Major Depressive Disorder (MDD)GUIDEDNCT02109939
Genomics Used to Improve DEpression Decisions
A study testing GeneSight Psychotropic in people with Major Depressive Disorder (MDD), run by Assurex Health Inc. at 61 sites in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depressive Disorder (MDD)
- What is being tested?
- GeneSight Psychotropic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,398 participants
- Where
- 61 sitesUnited States
- Study dates
- Apr 2014to 31 Jul 2017
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
- Delirium
- Dementia
- Amnestic and other cognitive disorder
Show all 20Show fewer
- 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.
Trial locations and contacts
61 sites in 1 country.
61 sites in 1 country
United States61 sites
University of Michigan
Ann Arbor, Michigan, 48109
Atlanta Institute of Medicine and Research
Atlanta, Georgia, 30328
Mood and Anxiety Program at Emory University
Atlanta, Georgia, 30329
Pharmasite Research
Baltimore, Maryland, 21208
Johns Hopkins Hospital
Baltimore, Maryland, 21224
Meridian Clinical Research
Bellevue, Nebraska, 68005
Northwest Clinical Research Center
Bellevue, Washington, 98007
CiTrials
Bellflower, California, 90706
Geriatric Outpatient Unit- McLean Hospital
Belmont, Massachusetts, 02478
United Medical Research Associates
Binghamton, New York, 13901
Birmingham Psychiatry Pharmaceutical Studies
Birmingham, Alabama, 35226
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Boston Clinical Trials
Boston, Massachusetts, 02131
Integrative Clinical Trials, LLC
Brooklyn, New York, 11229
SPRI Clinical Trials
Brooklyn, New York, 11235
Rush University Medical Center
Chicago, Illinois, 60612
Catalina Research Institute
Chino, California, 91710
University of Cincinnati Health
Cincinnati, Ohio, 45267
Cleveland Clinic
Cleveland, Ohio, 44120
MCB Clinical Research Centers, LLC
Colorado Springs, Colorado, 80910
Ohio State University Department of Psychiatry
Columbus, Ohio, 43210
CiTrials
Costa Mesa, California, 92705
University of Texas Southwestern Medical Center
Dallas, Texas, 76034
Midwest Clinical Research Center
Dayton, Ohio, 45417
Synergy Research Center
Escondido, California, 92025
Sarkis Clinical Trials
Gainesville, Florida, 32607
Baylor College of Medicine
Houston, Texas, 77030
The Institute of Psychiatric Research
Indianapolis, Indiana, 46202
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Clinical Neuroscience Solutions Healthcare
Jacksonville, Florida, 32256
Premier Psychiatric Research Institute, LLC
Lincoln, Nebraska, 68526
Lincoln Research
Lincoln, Rhode Island, 02865
Pharmacology Research Institute
Los Alamitos, California, 90720
Suburban Research Associates
Media, Pennsylvania, 19063
Clinical Neuroscience Solutions
Memphis, Tennessee, 38119
University of Minnesota
Minneapolis, Minnesota, 55454
Eastside Comprehensive Medical Center, LLC
New York, New York, 10021
North County Research
Oceanside, California, 92056
Oklahoma Clinical Research Center
Oklahoma City, Oklahoma, 73112
Clinical Neuroscience Solutions
Orlando, Florida, 32801
Mood and Anxiety Disorders Treatment and Research
Philadelphia, Pennsylvania, 19104
Summit Research Network
Portland, Oregon, 97210
Alliance Research Group
Richmond, Virginia, 20230
CiTrials
Riverside, California, 92506
Finger Lakes Clinical Research
Rochester, New York, 14618
Meridian Clinical Research
Savannah, Georgia, 31406
Behavioral Healthcare Associates
Schaumburg, Illinois, 60194
Summit Research Network
Seattle, Washington, 98104
Carman Research
Smyrna, Georgia, 30080
Frontier Institute
Spokane, Washington, 99204
Washington University School of Medicine
St Louis, Missouri, 63110
PsychCare Consultants Research
St Louis, Missouri, 63128
Stanford School of Medicine
Stanford, California, 94304
Clinical Research Trials of Florida, Inc
Tampa, Florida, 33607
Stedman Clinical Trials
Tampa, Florida, 33613
Viking Clinical Research
Temecula, California, 92591
Howard University Hospital Mental Health Clinic
Washington D.C., District of Columbia, 20060
Janus Center For Psychiatric Research
West Palm Beach, Florida, 33407
Kansas University Medical Center- Clinical Trials Unit
Wichita, Kansas, 67214
Elite Clinical Trials, Inc
Wildomar, California, 92595
UMASS Center for Psychopharmacologic Research and Treatment
Worcester, Massachusetts, 01655
About this study
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
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
- Major Depressive Disorder (MDD)
- Being tested
- GeneSight Psychotropic
- Keywords
- MDD, Pharmacogenomic, Pharmacogenomic Testing, Pharmacogenomics, Genetic Testing, Genetics, Major Depressive Disorder, GeneSight, Assurex, AssureRx, Psychotropic, Randomized, Double Blind, Placebo Controlled
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GeneSight PsychotropicGenetic
Also called Assurex Health, GeneSight
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.
| Study group | Role | What they receive |
|---|---|---|
| GeneSight Psychotropic Tested | Active comparator | Subjects being tested with GeneSight Psychotropic Receives: Genetic: GeneSight Psychotropic |
| Treatment As Usual | Placebo comparator | This group of subjects will not see their GeneSIght results or know whether or not they are in either arm until after week 12. Receives: Genetic: GeneSight Psychotropic |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from baseline to end of Week 8
Secondary outcomes (22)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to week 24 visit info
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2014 (estimated)
- Study startApr 2014
- Primary completion20 Apr 2017
- Study completion31 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Major Depressive Disorder (MDD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 1,398 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assurex Health Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Michigan
- Responsible party
- Sponsor
- Investigators
- John Greden, Ph.D, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02109939
- Sponsor's protocol ID
- ARX1006
- Acronym
- GUIDED
- Status last verified
- Jan 2020
- First submitted
- 4 Apr 2014
- Last updated
- 14 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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 31881956Thase 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 31721487Greden 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