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Individualizing Antidepressant Treatment Using Pharmacogenomics and EHR-driven Clinical Decision Support (MyGenes)

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ClinicalTrials.gov Identifier: NCT03952494
Recruitment Status : Not yet recruiting
First Posted : May 16, 2019
Last Update Posted : May 16, 2019
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Brief Summary:
The purpose of this study is to understand the effectiveness of pharmacogenomic testing in using antidepressants and to understand how EHR - driven clinical decision support system can be used to deliver PGx test results by healhcare providers.

Condition or disease Intervention/treatment Phase
Depression Genetic: Genecept Assay Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The myGenes Study:Individualizing Antidepressant Treatment Using Pharmacogenomics and EHR-driven Clinical Decision Support
Estimated Study Start Date : July 1, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antidepressants

Arm Intervention/treatment
Experimental: Intervention group
Intervention group will have the PGx test results available via Epic, three days after the biospecimen is received.
Genetic: Genecept Assay
Genecept Assay, a genetic test produced by Genomind, Inc., King of Prussia, Pennsylvania,that analyzes both pharmacokinetic and pharmacodynamic genes. The current test includes the analysis of 12 pharmacodynamic genes and six pharmacokinetic CYP450 genes that have been shown in numerous clinical studies to have implications for response to treatments used for depression, anxiety, OCD, ADHD, bipolar disorder, PTSD, autism, schizophrenia, chronic pain and substance abuse. The genes assessed by the assay target major hepatic enzymes and key neurotransmitter pathways including serotonin, dopamine, norepinephrine and glutamate.

Experimental: Control group

The control group will be considered in TAU(treatment as usual) group but will have the PGx test results available after 24 weeks.

Note: Patient in both the groups will be followed for 24 weeks and will take questionnaires every other week.

Genetic: Genecept Assay
Genecept Assay, a genetic test produced by Genomind, Inc., King of Prussia, Pennsylvania,that analyzes both pharmacokinetic and pharmacodynamic genes. The current test includes the analysis of 12 pharmacodynamic genes and six pharmacokinetic CYP450 genes that have been shown in numerous clinical studies to have implications for response to treatments used for depression, anxiety, OCD, ADHD, bipolar disorder, PTSD, autism, schizophrenia, chronic pain and substance abuse. The genes assessed by the assay target major hepatic enzymes and key neurotransmitter pathways including serotonin, dopamine, norepinephrine and glutamate.




Primary Outcome Measures :
  1. Response, as defined by > 50% reduction in Hamilton Depressing Rating Scale ( HAM-D) [ Time Frame: 24 weeks ]
    The Hamilton Depression Rating Scale is used for rating the severity of depressive symptoms. Scores range from 0 to 50, with higher scores indicating greater severity of depression. The scoring system is as follows- 0-7 = Normal 8-13 = Mild Depression 14-18 = Moderate Depression 19-23 = Severe Depression > 23 = Very severe Depression.

  2. Remission, as defined by < 8 on Hamilton Depressing Rating Scale ( HAM-D). [ Time Frame: 24 weeks ]
    The Hamilton Depression Rating Scale is used for rating the severity of depressive symptoms. Scores range from 0 to 50, with higher scores indicating greater severity of depression. The scoring system is as follows- 0-7 = Normal 8-13 = Mild Depression 14-18 = Moderate Depression 19-23 = Severe Depression > 23 = Very severe Depression.

  3. Conformance between antidepressant medication prescription changes and recommendations from the pharmacogenomics testing [ Time Frame: 24 weeks ]
    Conformance is defined as the number of prescriptions that are in agreement with clinical decision support recommendations based on pharmacogenomics test results.


Secondary Outcome Measures :
  1. Self-reported side effects [ Time Frame: 24 weeks ]
    FIBSER (Frequency, intensity and burden of side effects rating) questionnaire will be administered to assess the frequency, severity and degree of impairment related to side effects including nausea, headache, vomiting, GI distress, and sexual dysfunction. Frequency of side-effects are rated from 0-6, with 0 signifying no side effects and score of 6 showing that the effects are present all the time. Similarly intensity is also rated from 0-6 with 0 demonstrating no side effects and 6 signifying that the intensity is intolerable. Interference of side effects in day to day function is also rated in the same way. A reading of 0 tells us that there is no impairment of day-to-day functions and a reading of 6 depicts inability to function.

  2. Social role and activities [ Time Frame: 24 weeks ]

    PROMIS assessment (Patient-Reported Outcomes Measurement Information System) which is a tool to assess the physical, mental and social health of the patients will be administered. PROMIS assess the ability of patients in performing day social roles and activities by measuring satisfaction levels of patients in their abilities, including performing daily routines for self, family and friends, entertainment with others outside home, meeting the needs of family and friends, performing daily routines for self, family and friends.

    The scale has the following categories- Not at all, a little bit, somewhat, quite a bit and very much.




Information from the National Library of Medicine

Choosing 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 about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients who quality the criteria below:

  • Patients with nonpsychotic MDD
  • Patients who would like to either start a new antidepressant or change their existing antidepressant treatment
  • Patients for whom antidepressant treatment is deemed appropriate by the treating clinician
  • >18 years of age
  • Willingness to provide signed informed consent to participate in the study
  • Will be following up or continuously visiting their physician

Providers:

  • Outpatient practice providers
  • Providers who are familiar with Epic

Exclusion Criteria:

Patients:

  • Patients with medical contraindications that preclude antidepressant treatment
  • Patients with schizophrenia, schizoaffective disorder, or who have Bipolar I disorder
  • Patients currently on antipsychotic medications (e.g., typical and atypical antipsychotic drugs) and mood stabilizing agents (e.g., lithium, carbamazepine, valproate, lamotrigine, gabapentin, or other anticonvulsants)
  • Patients who are pregnant or have severe cognitive impairment
  • Patients requiring urgent care or inpatient hospitalization at the time of consent

Providers:

• Unable or unwilling to commit time to introduce myGenes study to patients


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03952494


Contacts
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Contact: Jyotishman Pathak, PhD (646) 962-9415 Jyp2001@med.cornell.edu
Contact: Yiye Zhang, PhD (646) 962-9437 yiz2014@med.cornell.edu

Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
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Principal Investigator: Jyotishman Pathak, PhD Weill Cornell Medicine

Additional Information:
Publications of Results:
Murray CJ, Atkinson C, Bhalla K, Birbeck G, Burstein R, Chou D, Dellavalle R, Danaei G, Ezzati M, Fahimi A, Flaxman D, Foreman, Gabriel S, Gakidou E, Kassebaum N, Khatibzadeh S, Lim S, Lipshultz SE, London S, Lopez, MacIntyre MF, Mokdad AH, Moran A, Moran AE, Mozaffarian D, Murphy T, Naghavi M, Pope C, Roberts T, Salomon J, Schwebel DC, Shahraz S, Sleet DA, Murray, Abraham J, Ali MK, Atkinson C, Bartels DH, Bhalla K, Birbeck G, Burstein R, Chen H, Criqui MH, Dahodwala, Jarlais, Ding EL, Dorsey ER, Ebel BE, Ezzati M, Fahami, Flaxman S, Flaxman AD, Gonzalez-Medina D, Grant B, Hagan H, Hoffman H, Kassebaum N, Khatibzadeh S, Leasher JL, Lin J, Lipshultz SE, Lozano R, Lu Y, Mallinger L, McDermott MM, Micha R, Miller TR, Mokdad AA, Mokdad AH, Mozaffarian D, Naghavi M, Narayan KM, Omer SB, Pelizzari PM, Phillips D, Ranganathan D, Rivara FP, Roberts T, Sampson U, Sanman E, Sapkota A, Schwebel DC, Sharaz S, Shivakoti R, Singh GM, Singh D, Tavakkoli M, Towbin JA, Wilkinson JD, Zabetian A, Murray, Abraham J, Ali MK, Alvardo M, Atkinson C, Baddour LM, Benjamin EJ, Bhalla K, Birbeck G, Bolliger I, Burstein R, Carnahan E, Chou D, Chugh SS, Cohen A, Colson KE, Cooper LT, Couser W, Criqui MH, Dabhadkar KC, Dellavalle RP, Jarlais, Dicker D, Dorsey ER, Duber H, Ebel BE, Engell RE, Ezzati M, Felson DT, Finucane MM, Flaxman S, Flaxman AD, Fleming T, Foreman, Forouzanfar MH, Freedman G, Freeman MK, Gakidou E, Gillum RF, Gonzalez-Medina D, Gosselin R, Gutierrez HR, Hagan H, Havmoeller R, Hoffman H, Jacobsen KH, James SL, Jasrasaria R, Jayarman S, Johns N, Kassebaum N, Khatibzadeh S, Lan Q, Leasher JL, Lim S, Lipshultz SE, London S, Lopez, Lozano R, Lu Y, Mallinger L, Meltzer M, Mensah GA, Michaud C, Miller TR, Mock C, Moffitt TE, Mokdad AA, Mokdad AH, Moran A, Naghavi M, Narayan KM, Nelson RG, Olives C, Omer SB, Ortblad K, Ostro B, Pelizzari PM, Phillips D, Raju M, Razavi H, Ritz B, Roberts T, Sacco RL, Salomon J, Sampson U, Schwebel DC, Shahraz S, Shibuya K, Silberberg D, Singh JA, Steenland K, Taylor JA, Thurston GD, Vavilala MS, Vos T, Wagner GR, Weinstock MA, Weisskopf MG, Wulf S, Murray; U.S. Burden of Disease Collaborators. The state of US health, 1990-2010: burden of diseases, injuries, and risk factors. JAMA. 2013 Aug 14;310(6):591-608. doi: 10.1001/jama.2013.13805.

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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT03952494     History of Changes
Other Study ID Numbers: 1806019379
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Antidepressive Agents
Psychotropic Drugs