Clinical Trial of Genomind

This study is currently recruiting participants. (see Contacts and Locations)Verified April 2015 by AssureRx Health, Inc.

Sponsor:AssureRx Health, Inc.Collaborator:University of MichiganInformation provided by (Responsible Party):AssureRx Health, Inc.

ClinicalTrials.gov Identifier:NCT02109939First received: April 4, 2014Last updated: April 22, 2015Last verified: April 2015History of Changes

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Trial record 13 of 31 for: Open Studies | "Mood Disorders" | United States, GeorgiaPrevious Study | Return to List | Next Study

Impact of GeneSight Psychotropic on Response to Psychotropic Treatment in Outpatients Suffering From a MajorDepressive Disorder (MDD) and Having Had an Inadequate Response to at Least One Psychotropic Medication Included inGeneSight Psychotropic (RCT)

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

Condition Intervention Phase

Major Depressive Disorder (MDD) Genetic: GeneSight Psychotropic Phase 4

Study Type: InterventionalStudy Design: Allocation: Randomized

Endpoint Classification: Efficacy StudyIntervention Model: Parallel AssignmentMasking: Double Blind (Subject, Caregiver)Primary Purpose: Treatment

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

Further study details as provided by AssureRx Health, Inc.:

Primary Outcome Measures:17-item Hamilton Depression (HAM-D17) score [ Time Frame: from baseline to end of Week 8 ] [ Designated as safety issue: No ]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.

Secondary Outcome Measures:16-item Quick Inventory of Depression Symptomology (QIDS-C16) scale [ Time Frame: from baseline to end of Week 8 ] [ Designated as safety issue: No ]Mean change in the 16-item Quick Inventory of Depression Symptomology (QIDS-C16) scale or the 9-item Patient Health Questionnaire (PHQ-9) from baseline to endof Week 8 of the study;

Percentage of responders at Week 8 for HAM-D17 [ Time Frame: Week 8 visit info ] [ Designated as safety issue: No ]Percentage of responders at Week 8 in each treatment group on the HAM-D17. A responder is defined as a participant with 50% change from baseline in total scalescore;

Percentage of responders at Week 12 for HAM-D17 [ Time Frame: Week 12 visit info ] [ Designated as safety issue: No ]Percentage of responders at Week 12 (defined as above) in each treatment group on the HAM-D17

Percentage of remitters at Week 12 defined as HAM-D17 7 [ Time Frame: week 12 visit info ] [ Designated as safety issue: No ]Percentage of remitters at Week 12 defined as HAM-D17 7

Percentage of remitters at Week 8 defined as HAM-D17 7 in each treatment group; [ Time Frame: week 8 visit info ] [ Designated as safety issue: No ]Percentage of remitters at Week 8 defined as HAM-D17 7 in each treatment group;

Time to response/remission of depressive symptoms over 8 weeks; [ Time Frame: week 8 and 12 visit info ] [ Designated as safety issue: No ]

Impact of GeneSight Psychotropic on Response to Psychotropic Treatmen... https://www.clinicaltrials.gov/ct2/show/study/NCT02109939?recr=Ope...

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Time to response/remission of depressive symptoms over 8 weeks;

Mean change in symptoms from baseline to week 24 across all scales in each treatment group. [ Time Frame: Baseline to week 24 visits ][ Designated as safety issue: No ]Mean change in symptoms from baseline to week 24 across all scales in each treatment group.

Percentage of responders at Week 8 for QIDS-C16 [ Time Frame: Week 8 visit info ] [ Designated as safety issue: No ]Percentage of responders at Week 8 in each treatment group on the QIDS-C16. A responder is defined as a participant with 50% change from baseline in total scalescore;

Percentage of responders at Week 8 for PHQ-9 [ Time Frame: Week 8 visit info ] [ Designated as safety issue: No ]Percentage of responders at Week 8 in each treatment group on the PHQ-9. A responder is defined as a participant with 50% change from baseline in total scale score;

Percentage of remitters at Week 12 defined as QIDS-C16 5 [ Time Frame: week 12 visit info ] [ Designated as safety issue: No ]Percentage of remitters at Week 12 defined as QIDS-C16 5

Percentage of remitters at Week 12 defined as PHQ-9

Study Start Date: April 2014Estimated Study Completion Date: February 2016Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)

Arms Assigned Interventions

Active Comparator: GeneSightPsychotropic TestedSubjects being tested with GeneSightPsychotropic

Genetic: GeneSight PsychotropicThe 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 inmultiple 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 HealthGeneSight

Placebo Comparator: Treatment AsUsualThis group of subjects will not see theirGeneSIght results or know whether ornot they are in either arm.

Genetic: GeneSight PsychotropicThe 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 inmultiple 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 HealthGeneSight

Show Detailed Description

EligibilityAges Eligible for Study: 18 Years and olderGenders Eligible for Study: BothAccepts Healthy Volunteers: NoCriteriaInclusion 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 eachpatient 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 weeksof 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:

Deliriuma. Dementiab. Amnestic and other cognitive disorderc. Schizophrenia or other psychotic disorder;d.

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 theliver; 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 priorto screening; malignancy more than 1 year prior to screening must have been local and without metastasis and/or recurrence, and if treated with chemotherapy, withoutnervous 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;


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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 LocationsChoosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more aboutthis study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02109939

Hide Study LocationsLocationsUnited States, Alabama

University of Alabama at Birmingham RecruitingBirmingham, Alabama, United States, 35233Contact: Richard Shelton, MD 205-975-3442 [email protected] Investigator: Richard Shelton, MD Sub-Investigator: Rachel Fargason, MD Sub-Investigator: Li Li, MD

United States, CaliforniaSynergy Research Center Terminated

Escondido, California, United States, 92025Pharmacology Research Institute Recruiting

Los Alamitos, California, United States, 90720Contact: Nader Oskooilar, MD 714-827-3667 [email protected] Investigator: Nader Oskooilar, MD Sub-Investigator: Jeffrey Litzinger, MD

CiTrials RecruitingSanta Ana, California, United States, 92705Contact: Evangelos Coskinas, M.D. 714-979-4101 [email protected] Investigator: Evangelos Coskinas, M.D.

Stanford School of Medicine RecruitingStanford, California, United States, 94304Contact: Charles DeBattista, MD 650-723-8324 [email protected] Investigator: Charles DeBattista, MD Sub-Investigator: Alan Schatzberg, MD Sub-Investigator: Hugh Brent Solvanson, MD, PhD

United States, District of ColumbiaHoward University Hospital Mental Health Clinic Recruiting

Washington, District of Columbia, United States, 20060Contact: William B Lawson, MD 202-865-6100 [email protected] Investigator: William B Lawson, MD Sub-Investigator: Mansoor Malik Sub-Investigator: Tanya Alim Sub-Investigator: Kamal Gandotra Sub-Investigator: Babur Bhatti Sub-Investigator: Matie Trewe Sub-Investigator: Urooj Saeed

United States, FloridaJanus Center For Psychiatric Research Recruiting

West Palm Beach, Florida, United States, 33407Contact: Janice Miller, MD 561-238-3030 [email protected] Investigator: Janice Miller, MD Sub-Investigator: Madeline Stam, MD

United States, GeorgiaMood and Anxiety Program at Emory University Recruiting

Altanta, Georgia, United States, 30329Contact: Boadie Dunlop, MD, MS 404-727-8969 [email protected] Investigator: Boadie Dunlop, MD, MS Sub-Investigator: Jeffrey Rakofsky, MD Sub-Investigator: Yilang Tang, MD, PhD

Atlanta Institute of Medicine and Research RecruitingAtlanta, Georgia, United States, 30328Contact: Angelo Sambunaris, MD 770-817-9200 [email protected] Investigator: Angelo Sambunaris, MD

United States, IllinoisRush University Medical Center Recruiting

Chicago, Illinois, United States, 60612Contact: Corey Goldstein, MD 773-330-4332 [email protected] Investigator: Corey Goldstein, MD Sub-Investigator: John Zajecka, MD


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United States, IndianaThe Institute of Psychiatric Research Recruiting

Indianapolis, Indiana, United States, 46202Contact: John Nurnberger, Ph.D, M.D. 317-274-8844 [email protected] Investigator: John Nurnberger, Ph.D, M.D Sub-Investigator: Yokesh Balaraman, M.D.

United States, IowaUniversity of Iowa Hospitals and Clinics Recruiting

Iowa City, Iowa, United States, 52242Contact: William Coreyll, MD 319-353-4434 [email protected] Investigator: William Coreyll, MD

United States, KansasKansas University Medical Center- Clinical Trials Unit Recruiting

Wichita, Kansas, United States, 67214Contact: Matthew Macaluso, D.O. 316-293-1833 [email protected] Investigator: Matthew Macaluso, D.O. Sub-Investigator: Sheldon Preskorn, M.D.

United States, MarylandJohns Hopkins Hospital Recruiting

Baltimore, Maryland, United States, 21224Contact: Peter Zandi, PhD 410-614-2686 [email protected] Investigator: Peter Zandi, PhD Sub-Investigator: Francis Mondimore, MD Sub-Investigator: Leslie Miller, MD

United States, MassachusettsGeriatric Outpatient Unit- McLean Hospital Recruiting

Belmont, Massachusetts, United States, 02478Contact: Brent Forester, MD 617-855-3492 [email protected] Investigator: Brent Forester, MD Sub-Investigator: Ben Legesse, MD

UMASS Center for Psychopharmacologic Research and Treatment RecruitingWorcester, Massachusetts, United States, 01655Contact: Anthony Rothschild, MD 508-856-1027 [email protected] Investigator: Anthony Rothschild, MD Sub-Investigator: Alison Trexler, MD Sub-Investigator: Nicole Ross, DO

United States, MichiganUniversity of Michigan Recruiting

Ann Arbor, Michigan, United States, 48109Contact: Melvin McInnis [email protected]

United States, MinnesotaUniversity of Minnesota Recruiting

Minneapolis, Minnesota, United States, 55454Contact: Barry Rittberg, MD 612-273-9813 [email protected] Investigator: Barry Rittberg, MD Sub-Investigator: David Bond, MD

United States, MissouriWashington University School of Medicine Recruiting

St. Louis, Missouri, United States, 63110Contact: Charles Conway, MD 314-362-0038 [email protected] Investigator: Charles Conway, MD Sub-Investigator: Donald Bohnenkamp, MD

United States, New YorkSPRI Clinical Trials Recruiting

Brooklyn, New York, United States, 11235Contact: Nick Vatakis, MD 718-616-2230 [email protected] Investigator: Nick Vatakis, MD Sub-Investigator: Eugeny Fink, MD

Eastside Comprehensive Medical Center, LLC RecruitingNew York, New York, United States, 10021Contact: Ram Shrivastava, MD 212-288-0138 [email protected] Investigator: Ram Shrivastava, MD

United States, OhioUniversity of Cincinnati Health Recruiting

Cincinnati, Ohio, United States, 45267Contact: Erik Nelson, MD 513-558-5115 [email protected] Investigator: Erik Nelson, MD Sub-Investigator: Cheryl McCullumsmith, MD

Cleveland Clinic RecruitingCleveland, Ohio, United States, 44120


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Contact: Amit Anand, MD 216-636-2841 [email protected] Investigator: Amit Anand, MD Sub-Investigator: Murat Altinay, MD

Ohio State University Department of Psychiatry RecruitingColumbus, Ohio, United States, 43210Contact: Subhdeep Virk, M.D. 614-293-7109 [email protected] Investigator: Subhdeep Virk, M.D. Sub-Investigator: Jessica Lammers, M.D. Sub-Investigator: Samar McCutcheon, M.D. Sub-Investigator: Amy Thompson, M.D. Sub-Investigator: Rita Aouad, M.D. Sub-Investigator: Kevin Reeves, M.D.

Midwest Clinical Research Center RecruitingDayton, Ohio, United States, 45417Contact: Bernadette D'Souza, MD 937-424-1050 [email protected] Investigator: Bernadette D'Souza, MD Sub-Investigator: Otto Dueno, MD Sub-Investigator: Jeffrey Bishop, MD

United States, OklahomaOklahoma Clinical Research Center Recruiting

Oklahoma City, Oklahoma, United States, 73112Contact: Marvin L Peyton, M.D. 405-753-4994 [email protected] Investigator: Marvin L Peyton, MD

United States, PennsylvaniaSuburban Research Associates Recruiting

Media, Pennsylvania, United States, 19063Contact: Shirkumar Hatti, M.D. 610-891-9024 [email protected] Investigator: Shirkumar Hatti, M.D. Sub-Investigator: Sudha Nair, M.D.

Mood and Anxiety Disorders Treatment and Research RecruitingPhiladelphia, Pennsylvania, United States, 19104Contact: Michael Thase, MD 215-746-6680 [email protected] Investigator: Michael Thase, MD Sub-Investigator: Mario Cristancho, MD Sub-Investigator: Mahendra T Bhati, MD Sub-Investigator: Theodore Satterthwaite, MD

United States, TexasUniversity of Texas Southwestern Medical Center Recruiting

Dallas, Texas, United States, 76034Contact: Mustafa Husain, M.D. 214-648-2806 [email protected]: Ahmad Raza, MD PHD 214-648-2806 [email protected] Investigator: Mustafa Husain, MD Sub-Investigator: Raza Ahmad, MD PHD

Baylor College of Medicine RecruitingHouston, Texas, United States, 77030Contact: Asim Shah, MD 713-873-5270 [email protected] Investigator: Asim Shah, MD Sub-Investigator: Sanjay Mathew, MD

United States, WashingtonFrontier Institute Recruiting

Spokane, Washington, United States, 99204Contact: John Tran, MD 509-710-8750 [email protected] Investigator: John Tran, MD Sub-Investigator: Melody Stupey, MD

Sponsors and CollaboratorsAssureRx Health, Inc.University of MichiganInvestigatorsPrincipal Investigator: John Greden, Ph.D University of Michigan

More InformationNo publications provided

Responsible Party: AssureRx Health, Inc.ClinicalTrials.gov Identifier: NCT02109939 History of ChangesOther Study ID Numbers: ARX1006Study First Received: April 4, 2014Last Updated: April 22, 2015Health Authority: USA: INC Research

USA: Copernicus Group IRB

Keywords provided by AssureRx Health, Inc.:


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MDDPharmacogenomicPharmacogenomic TestingPharmacogenomicsGenetic TestingGeneticsMajor Depressive Disorder

GeneSightAssurexAssureRxPsychotropicRandomizedDouble BlindPlacebo Controlled

Additional relevant MeSH terms:DepressionDepressive DisorderDepressive Disorder, MajorBehavioral SymptomsMental Disorders

Mood DisordersPsychotropic DrugsCentral Nervous System AgentsPharmacologic ActionsTherapeutic Uses

ClinicalTrials.gov processed this record on June 09, 2015


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Clinical Trial of Genomind