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Impact of GeneSight Psychotropic on Response to Psychotropic Treatmen...

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https://www.clinicaltrials.gov/ct2/show/study/NCT02109939?recr=Ope...

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Trial record 13 of 31 for:

Open Studies | "Mood Disorders" | United States, Georgia

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Impact of GeneSight Psychotropic on Response to Psychotropic Treatment in Outpatients Suffering From a Major
Depressive Disorder (MDD) and Having Had an Inadequate Response to at Least One Psychotropic Medication Included in
GeneSight Psychotropic (RCT)
This study is currently recruiting participants. (see Contacts and Locations)

ClinicalTrials.gov Identifier:

NCT02109939

Verified April 2015 by AssureRx Health, Inc.

First received: April 4, 2014
Last updated: April 22, 2015
Last verified: April 2015
History of Changes

Sponsor:

AssureRx Health, Inc.
Collaborator:

University of Michigan
Information provided by (Responsible Party):

AssureRx Health, Inc.
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Purpose
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

Intervention

Phase

Major Depressive Disorder (MDD)

Genetic: GeneSight Psychotropic

Phase 4

Study Type:
Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 GeneSight
Psychotropic on Response to Psychotropic Treatment in Outpatients Suffering From a Major Depressive Disorder (MDD) and Having Had - Within the
Current 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 end
of 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 scale
score;
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 ]

6/11/2015 1:08 AM

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 <5 [ Time Frame: week 12 visit info ] [ Designated as safety issue: No ] Percentage of remitters at Week 12 defined as PHQ-9 <5 Percentage of remitters at Week 12 defined as CGI-S ≤1 [ Time Frame: week 12 visit info ] [ Designated as safety issue: No ] Percentage of remitters at Week 12 defined as CGI-S ≤1 Percentage of responders at Week 12 for QIDS-C16 [ 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 QIDS-C16 Percentage of responders at Week 12 for PHQ-9 [ 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 PHQ-9 Percentage of responders at Week 12 for CGI-S [ 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 CGI-S (defined as a change in category of severity of at least 1 point).gov/ct2/show/study/NCT02109939?recr=Ope. Mean percent response from baseline to week 24 across all scales in each treatment group. defined as a scores of 01. 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. Mean change in symptoms from week 12 to week 24 across all scales in each treatment group. [ Time Frame: week 12 to 24 visit info ] [ Designated as safety issue: No ] Mean change in percent remission from week 12 to week 24 across all scales in each treatment group.. [ Time Frame: week 8 visit info ] [ Designated as safety issue: No ] Percentage of remitters at Week 8 defined as QIDS-C16 ≤5 in each treatment group. [ Time Frame: week 8 visit info ] [ Designated as safety issue: No ] Percentage of remitters at Week 8 defined as PHQ-9 <5 in each treatment group. Percentage of remitters at Week 8 defined as QIDS-C16 ≤5 in each treatment group. or 06). 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. 05. 2 of 7 https://www.. Percentage of responders at Week 12 for CGI-I [ 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 Clinical Global Impression of Improvement (CGI-I. Percentage of responders at Week 12 for CGI-EI [ 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 Clinical Global Impression of Efficacy (CGI-EI.Impact of GeneSight Psychotropic on Response to Psychotropic Treatmen. [ Time Frame: Baseline to week 24 visit info ] [ Designated as safety issue: No ] Mean percent response from baseline to week 24 across all scales in each treatment group. A responder is defined as a participant with 50% change from baseline in total scale score. Time to response/remission of depressive symptoms over 8 weeks. Mean percent response from week 12 to week 24 across all scales in each treatment group. 02. [ 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. Mean percent remission from baseline to week 24 across all scales in each treatment group.clinicaltrials. Mean change in symptoms from baseline to week 24 across all scales in each treatment group. Estimated Enrollment: 300 6/11/2015 1:08 AM . [ Time Frame: week 12 to 24 visit info ] [ Designated as safety issue: No ] Mean change in symptoms from week 12 to week 24 across all scales in each treatment group. [ Time Frame: Baseline to week 24 visit info ] [ Designated as safety issue: No ] Mean percent remission from baseline to week 24 across all scales in each treatment group.. [ Time Frame: week 8 and 12 visit info ] [ Designated as safety issue: No ] Time to response/remission of depressive symptoms over 12 weeks. Mean change in percent remission from week 12 to week 24 across all scales in each treatment group. Percentage of remitters at Week 8 defined as PHQ-9 <5 in each treatment group.. defined as a score from 1 to 3). A responder is defined as a participant with 50% change from baseline in total scale score. Time to response/remission of depressive symptoms over 12 weeks. [ Time Frame: week 12 to 24 visit info ] [ Designated as safety issue: No ] Mean percent response from week 12 to week 24 across all scales in each treatment group.

Impact of GeneSight Psychotropic on Response to Psychotropic Treatmen.. hepatic insufficiency (3X ULN for AST and/or ALT).gov/ct2/show/study/NCT02109939?recr=Ope.. Schizophrenia or other psychotic disorder. and typical and atypical antipsychotics are also represented. 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. including a full representation of the SSRI and SNRI drug classes. cirrhosis of the liver. Suffer from a Major Depressive Episode meeting DSM-IV-TR criteria.clinicaltrials. 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. Be ≥18 years of age. Amnestic and other cognitive disorder d.. need for therapies that may obscure the results of treatment and/or of the study. Patients with a current Axis I diagnosis of: a. including all visits and tests. The GeneSight Psychotropic product contains the most commonly prescribed antidepressant and antipsychotic medications. 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. Patients with a diagnosis of Bipolar I or II disorder. Anticipated inability to attend scheduled study visits. an MAOI.. liver transplant recipient. Have had an inadequate response within the current episode to at least 1 psychotropic treatment. an MAOI. 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. 3 of 7 https://www. Patients with significant unstable medical condition. tricyclic antidepressants. Patient is currently in an inpatient facility. Agree to abide by the study protocol and its restrictions and be able to complete all aspects of the study. Exclusion Criteria: Patients posing a serious suicidal risk and/or in need of immediate hospitalization as judged by the investigator. delusions. Study Start Date: April 2014 Estimated Study Completion Date: February 2016 Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure) Arms Assigned Interventions Active Comparator: GeneSight Psychotropic Tested Genetic: GeneSight Psychotropic Subjects being tested with GeneSight Psychotropic The GeneSight Psychotropic product is a pharmacogenomic decision support tool that helps clinicians to make informed. Have a total baseline score on the QIDS-C16 and QIDS-SR16 rating scale ≥11. Participation in another clinical trial within 30 days of the screening visit. including a full representation of the SSRI and SNRI drug classes. 6/11/2015 1:08 AM . Dementia c. tricyclic antidepressants. malignancy more than 1 year prior to screening must have been local and without metastasis and/or recurrence. Patients with a history of prior pharmacogenomic testing. without nervous system complications. and if treated with chemotherapy. Patients who in the judgment of the Investigator may be unreliable or uncooperative with the evaluation procedure outlined in this protocol. Any change in psychotropic medication (including change in dosage) between screening and randomization. life threatening disease. 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. and typical and atypical antipsychotics are also represented. malignancy (except basal cell carcinoma) and/or chemotherapy within 1 year prior to screening. Patients having experienced hallucinations. 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. Delirium b. or any psychotic symptomatology within the current depressive episode or during prior depressive episodes. Patients who meet DSM-IV-TR criteria for any significant current substance use disorder. Patients with a history of hypothyroidism unless taking a stable dose of thyroid medication and asymptomatic or euthyroid for 6 months. Other Names: Assurex Health GeneSight Show Detailed Description Eligibility Ages Eligible for Study: Genders Eligible for Study: Accepts Healthy Volunteers: 18 Years and older Both No Criteria Inclusion Criteria: Be able to understand the requirements of the study and provide written informed consent to participate in this study. evidence-based decisions about proper drug selection. The GeneSight Psychotropic product contains the most commonly prescribed antidepressant and antipsychotic medications.

MD Sub-Investigator: Madeline Stam.. California. District of Columbia Howard University Hospital Mental Health Clinic Washington. MD United States. United States. Georgia. 20060 Contact: William B Lawson. MD Sub-Investigator: Jeffrey Litzinger. Illinois. United States. M. United States. United States. For general information. 30329 Contact: Boadie Dunlop. MD 770-817-9200 Principal Investigator: Angelo Sambunaris. California. Florida Recruiting Janus Center For Psychiatric Research West Palm Beach.. MD 561-238-3030 jmillermd@januspsychresearch. MD Sub-Investigator: John Zajecka.gov/ct2/show/study/NCT02109939?recr=Ope. United States. Patients receiving ECT. DBS or TMS treatment (should a Subject receive any of these treatments they must be discontinued from the study).com Principal Investigator: Nader Oskooilar. Patients who are known to be pregnant or lactating. 4 of 7 https://www.com Principal Investigator: Janice Miller. California Synergy Research Center Escondido.edu 6/11/2015 1:08 AM .edu United States. 92705 Contact: Evangelos Coskinas. MD Recruiting Corey_goldstein@rush. Alabama University of Alabama at Birmingham Birmingham. 92025 Terminated Pharmacology Research Institute Los Alamitos. PhD Atlanta Institute of Medicine and Research Atlanta. United States. MD Sub-Investigator: Hugh Brent Solvanson. Georgia.com Stanford School of Medicine Stanford. MD Sub-Investigator: Yilang Tang.D. Florida. MD 773-330-4332 Principal Investigator: Corey Goldstein.edu Principal Investigator: William B Lawson. MS Sub-Investigator: Jeffrey Rakofsky. MD 714-827-3667 noskooilar@priresearch. Please refer to this study by its ClinicalTrials. 94304 Contact: Charles DeBattista. PhD Recruiting United States. Illinois Rush University Medical Center Chicago. MD. Patients with a history of gastric bypass surgery. 33407 Contact: Janice Miller. you or your doctor may contact the study research staff using the Contacts provided below. Recruiting Coskinas@citrials. Georgia Mood and Anxiety Program at Emory University Altanta..com United States. Alabama. 30328 Contact: Angelo Sambunaris.Impact of GeneSight Psychotropic on Response to Psychotropic Treatmen. Contacts and Locations Choosing to participate in a study is an important personal decision. United States. United States.edu Recruiting a. Talk with your doctor and family members or friends about deciding to join a study. 35233 Contact: Richard Shelton. MD. MD Recruiting rshelton@uab. M. MD.edu Principal Investigator: Charles DeBattista. 60612 Contact: Corey Goldstein. MD Recruiting CiTrials Santa Ana. 714-979-4101 Principal Investigator: Evangelos Coskinas. see Learn About Clinical Studies. California. District of Columbia. MD Sub-Investigator: Rachel Fargason. MD 202-865-6100 wblawson@howard. To learn more about this study.gov identifier: NCT02109939 Hide Study Locations Locations United States. 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 Recruiting United States. MD Recruiting bdunlop@emory.sambunaris@atlanta-institute. MD Sub-Investigator: Li Li. United States. 90720 Contact: Nader Oskooilar.D. MD Sub-Investigator: Alan Schatzberg. United States. California. MD 650-723-8324 debattista@stanford.clinicaltrials.. MS 404-727-8969 Principal Investigator: Boadie Dunlop. MD 205-975-3442 Principal Investigator: Richard Shelton. MD.

Kansas. MD Recruiting conwayc@wustl. MD Sub-Investigator: Cheryl McCullumsmith. MD 617-855-3492 bforester@harvard. United States. D. Missouri.com United States. 5 of 7 https://www. Recruiting mmacaluso@kumc.D. Iowa University of Iowa Hospitals and Clinics Iowa City. Sub-Investigator: Sheldon Preskorn.D. Kansas Kansas University Medical Center. Recruiting jnurnberger@iupui. 316-293-1833 Principal Investigator: Matthew Macaluso. Ohio University of Cincinnati Health Cincinnati. United States. Minnesota University of Minnesota Minneapolis. M.umich. 44120 Recruiting 6/11/2015 1:08 AM .Impact of GeneSight Psychotropic on Response to Psychotropic Treatmen.D. MD Recruiting nvatakis@spristudy. United States.O.com Eastside Comprehensive Medical Center. Ohio.gov/ct2/show/study/NCT02109939?recr=Ope.edu Principal Investigator: Barry Rittberg.org Principal Investigator: Anthony Rothschild. 21224 Contact: Peter Zandi.. M. MD 718-616-2230 Principal Investigator: Nick Vatakis.edu United States. MD Sub-Investigator: Leslie Miller. MD Recruiting drramshrivastava@aol. Missouri Washington University School of Medicine St. Ph. MD Recruiting United States. MD 319-353-4434 Principal Investigator: William Coreyll. LLC New York. MD 314-362-0038 Principal Investigator: Charles Conway. United States.D. Indiana The Institute of Psychiatric Research Indianapolis. Massachusetts Geriatric Outpatient Unit. 46202 Contact: John Nurnberger. 48109 Contact: Melvin McInnis mmcinnis@med. United States. United States.McLean Hospital Belmont. DO United States. MD Recruiting william-coryell@uiowa. Michigan. MD 508-856-1027 anthony. 10021 Contact: Ram Shrivastava. Louis.edu Principal Investigator: Erik Nelson.. New York. PhD Sub-Investigator: Francis Mondimore. PhD 410-614-2686 pzandi1@jhu. United States.edu United States. MD Sub-Investigator: Donald Bohnenkamp. Indiana.clinicaltrials.Clinical Trials Unit Wichita. New York.edu United States. 63110 Contact: Charles Conway.D. United States. MD Sub-Investigator: Eugeny Fink... 52242 Contact: William Coreyll. 55454 Contact: Barry Rittberg. 01655 Contact: Anthony Rothschild. MD Sub-Investigator: Alison Trexler. MD Recruiting United States. M. Ohio. United States. MD 212-288-0138 Principal Investigator: Ram Shrivastava. Massachusetts. MD 612-273-9813 rittb001@umn.edu Recruiting United States.edu Principal Investigator: Peter Zandi. Ph. MD 513-558-5115 erik. Michigan University of Michigan Ann Arbor. Minnesota. MD Recruiting Recruiting UMASS Center for Psychopharmacologic Research and Treatment Worcester. 317-274-8844 Principal Investigator: John Nurnberger. 45267 Contact: Erik Nelson. 67214 Contact: Matthew Macaluso.D Sub-Investigator: Yokesh Balaraman. United States. 11235 Contact: Nick Vatakis. M.nelson@uc. 02478 Contact: Brent Forester. New York SPRI Clinical Trials Brooklyn. MD Sub-Investigator: Nicole Ross.mclean. United States.edu Principal Investigator: Brent Forester. Massachusetts.O. MD Sub-Investigator: David Bond. United States. MD Recruiting Cleveland Clinic Cleveland. Maryland Johns Hopkins Hospital Baltimore. Maryland. United States.edu United States. Iowa. D. MD Sub-Investigator: Ben Legesse.rothschild@umassmemorial. United States.

MD 713-873-5270 Principal Investigator: Asim Shah.edu Principal Investigator: Michael Thase. 2014 Last Updated: April 22.clinicaltrials. 77030 Contact: Asim Shah.D. Recruiting Shatti@suburbanresearch. Oklahoma. Inc. MD Sub-Investigator: Jeffrey Bishop.raza@utsouthwestern. MD Recruiting United States. 19063 Contact: Shirkumar Hatti. Washington. Inc. M. MD PHD Baylor College of Medicine Houston. MD Sub-Investigator: Mario Cristancho. 214-648-2806 mustafa. M. United States.gov/ct2/show/study/NCT02109939?recr=Ope. 45417 Contact: Bernadette D'Souza. United States. MD Sub-Investigator: Melody Stupey. Sub-Investigator: Jessica Lammers. MD Sub-Investigator: Raza Ahmad. ClinicalTrials. M. 99204 Contact: John Tran. Sub-Investigator: Samar McCutcheon. Recruiting subhdeep.org Ohio State University Department of Psychiatry Columbus.D.D. Texas Recruiting University of Texas Southwestern Medical Center Dallas.edu Contact: Ahmad Raza. M. MD Sub-Investigator: Sanjay Mathew.D..virk@osumc. 405-753-4994 drpeyton@okcrc.net Principal Investigator: Marvin L Peyton.D.D University of Michigan More Information No publications provided Responsible Party: AssureRx Health.D. MD Sub-Investigator: Theodore Satterthwaite. MD 216-636-2841 Principal Investigator: Amit Anand.D. MD 215-746-6680 thase@mail. MD Recruiting United States. MD https://www. MD Recruiting aashah@bcm. 19104 Contact: Michael Thase. Texas. MD 509-710-8750 jtranfi@smhca. 610-891-9024 Principal Investigator: Shirkumar Hatti. M.upenn.D.D. MD 937-424-1050 Principal Investigator: Bernadette D'Souza. M. Pennsylvania. Ohio. M.: 6/11/2015 1:08 AM . Oklahoma Oklahoma Clinical Research Center Oklahoma City. Sub-Investigator: Rita Aouad.edu United States. Texas. University of Michigan Investigators Principal Investigator: John Greden.Impact of GeneSight Psychotropic on Response to Psychotropic Treatmen.. Sub-Investigator: Kevin Reeves. United States. United States. MD Recruiting bdsouza@midwestclinical.com United States.husain@utsouthwestern. 76034 Contact: Mustafa Husain.D. Pennsylvania.D. 614-293-7109 Principal Investigator: Subhdeep Virk.com Mood and Anxiety Disorders Treatment and Research Philadelphia. Ohio. United States. Sub-Investigator: Sudha Nair. Sub-Investigator: Amy Thompson. MD Sub-Investigator: Murat Altinay. Washington Frontier Institute Spokane.org Principal Investigator: John Tran.edu Midwest Clinical Research Center Dayton. Pennsylvania Suburban Research Associates Media. MD Sub-Investigator: Mahendra T Bhati. M.edu Principal Investigator: Mustafa Husain.med. 43210 Contact: Subhdeep Virk. 73112 Contact: Marvin L Peyton.D. M.gov Identifier: NCT02109939 History of Changes Other Study ID Numbers: ARX1006 Study First Received: April 4.. 2015 Health Authority: USA: INC Research USA: Copernicus Group IRB Keywords provided by AssureRx Health. 6 of 7 Contact: Amit Anand. United States. M.. M. MD Recruiting Sponsors and Collaborators AssureRx Health. MD PHD 214-648-2806 ahmad. M. United States. United States. MD Sub-Investigator: Otto Dueno. Inc. ananda@ccf. Ph.

. 2015 6/11/2015 1:08 AM .. 7 of 7 https://www. MDD Pharmacogenomic Pharmacogenomic Testing Pharmacogenomics Genetic Testing Genetics Major Depressive Disorder GeneSight Assurex AssureRx Psychotropic Randomized Double Blind Placebo Controlled Additional relevant MeSH terms: Depression Depressive Disorder Depressive Disorder.Impact of GeneSight Psychotropic on Response to Psychotropic Treatmen.gov/ct2/show/study/NCT02109939?recr=Ope.gov processed this record on June 09..clinicaltrials.. Major Behavioral Symptoms Mental Disorders Mood Disorders Psychotropic Drugs Central Nervous System Agents Pharmacologic Actions Therapeutic Uses ClinicalTrials.