Can Genetic Testing help you find. the right medication. for your depression?
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- Sharleen Hoover
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1 Can Genetic Testing help you find the right medication for your depression?
2 One of the worst side effects of a psychotropic medication is when it just doesn t work Selecting the medication that s right for someone is often a challenge. But finding the appropriate medication may help avoid additional challenges that can lead to worsening depression, the need to change medication, and frustration for you and your clinician. Pharmacogenomic testing may provide answers. Your doctor is participating in a study to see if a genetic test can be used to help select the most appropriate medication for you, resulting in improved response to the medication. What is the study? The study is trying to see if a genetic test (called GeneSight ) is helpful in guiding clinicians selection of medications for depression. What is GeneSight? GeneSight is a fast, simple, and non-invasive genetic test that may help determine how an individual s genetic variations can influence their response to medication. You might be eligible to participate in this study if: Pharmacogenomics uses information about a person s genetic makeup,or genome, to choose the drugs and drug doses that are likely to work best for that particular person. National Institutes of Health National Human Genome Research Institute You are trying or have recently tried one of the psychiatric medications on page 7, and Your symptoms of depression are not improving despite at least 6 weeks on the treatment you are receiving, and/or You are unable to tolerate the medication and have discontinued it. 1
3 GeneSight Clinical Study: The Details How does the study work? 1 This is a 2 part study occurring over 24 weeks: 1. The first part of the study consists of 12 weeks with a total of 5 study visits. 2 In this part of the study, you will randomly be assigned to one of two groups: The group whose clinicians receive GeneSight results and can use them to select medications for you during the 12 The group whose clinicians do not receive GeneSight results until the end of the 12 At each study visit you will be asked questions about your depression and your overall health. 2. The second phase also consists of 12 weeks but with only 1 study visit scheduled during the 24th week. In this part of the study, all participants and their clinicians will receive the GeneSight results and they can be used during the 12 What are the risks of the study? The GeneSight test is performed using a simple, non-invasive cheek swab, which is considered low risk. Sometimes people have allergic reactions and there is risk of having allergic reactions with your prescribed medications or a possible allergic reaction at the test site for the GeneSight genetic swab. Other risks of the study are those associated with the medications the study doctor selects to treat your depression. About GeneSight GeneSight is a genetic test that analyzes patient genomic information and integrates it with advanced bioinformatics and drug pharmacology. The test is administered (DNA collection) with a simple cheek swab -- no blood draw required. If you are in the group where GeneSight is used to help guide your clinician s prescribing decision, your GeneSight results will be delivered within 36 hours after sample receipt. The GeneSight report will group the most commonly prescribed medications for depression into three color-coded categories for fast, easy to use information that may assist your healthcare professional in treatment choices. GeneSight - developed by Assurex Health based on technology licensed from Mayo Clinic and Cincinnati Children s Hospital Medical Center 3
4 The GeneSight Report Medications included on the GeneSight report: bupropion (Wellbutrin ) desvenlafaxine (Pristiq ) selegiline (Emsam ) vilazodone (Viibryd ) fluphenazine (Prolixin ) lurasidone (Latuda ) paliperidone (Invega ) ziprasidone (Geodon ) GeneSight Psychotropic Results DOB: 7/22/1984 Reference: 1456CIP Order Number: 9299 Clinician: Sample Clinician Report Date: 6/13/2013 USE AS DIRECTED USE AS DIRECTED Patient, Sample Antidepressants USE WITH CAUTION amitriptyline (Elavil ) [2] citalopram (Celexa ) [3] clomipramine (Anafranil ) [2,7] doxepin (Sinequan ) [2] escitalopram (Lexapro ) [3] imipramine (Tofranil ) [3] sertraline (Zoloft ) [3] trazodone (Desyrel ) [2] Antipsychotics USE WITH CAUTION asenapine (Saphris ) [2,7] quetiapine (Seroquel ) [2] thiothixene (Navane ) [2,7] [2]: Serum level may be too low, higher doses may be required. [3]: Difficult to predict dose adjustments due to conflicting variations in metabolism. [4]: Genotype may impact drug mechanism of action and result in reduced efficacy. USE WITH INCREASED CAUTION AND WITH MORE FREQUENT MONITORING desipramine (Norpramin ) [2] duloxetine (Cymbalta ) [2,7] fluoxetine (Prozac ) [2] fluvoxamine (Luvox ) [2,7] mirtazapine (Remeron ) [2,7] nortriptyline (Pamelor ) [2] paroxetine (Paxil ) [2,4,6] venlafaxine (Effexor ) [3] USE WITH INCREASED CAUTION AND WITH MORE FREQUENT MONITORING aripiprazole (Abilify ) [2] chlorpromazine (Thorazine ) [2,7] clozapine (Clozaril ) [2,7] haloperidol (Haldol ) [2] iloperidone (Fanapt ) [2] olanzapine (Zyprexa ) [2,7] perphenazine (Trilafon ) [2,7] risperidone (Risperdal ) [2] thioridazine (Mellaril ) [2,7] [6]: Use of this drug may increase risk of side effects. [7]: Serum level may be too low in smokers. All psychotropic medications require clinical monitoring. Drugs are reported in alphabetical order. This report is not intended to imply that the drugs listed are approved for the same indications or that they are comparable in safety or efficacy. The brand name is shown for illustrative purposes only; other brand names may be available. The prescribing physician should review the prescribing information for the drug(s) being considered and make treatment decisions based on the patient s individual needs and the characteristics of the drug prescribed. amitriptyline (Elavil ) aripiprazole (Abilify ) asenapine (Saphris ) bupropion (Wellbutrin ) chlorpromazine (Thorazine ) citalopram (Celexa ) clomipramine (Anafranil ) clozapine (Clozaril ) desipramine (Norpramin ) desvenlafaxine (Pristiq ) doxepin (Sinequan ) duloxetine (Cymbalta ) escitalopram (Lexapro ) fluoxetine (Prozac ) fluphenazine (Prolixin ) fluvoxamine (Luvox ) haloperidol (Haldol ) iloperidone (Fanapt ) imipramine (Tofranil ) levomilnacipran (Fetzima ) lurasidone (Latuda ) mirtazapine (Remeron ) nortriptyline (Pamelor ) olanzapine (Zyprexa ) paliperidone (Invega ) paroxetine (Paxil ) perphenazine (Trilafon ) quetiapine (Seroquel ) risperidone (Risperdal ) selegiline (Emsam ) sertraline (Zoloft ) thioridazine (Mellaril ) thiothixene (Navane ) trazodone (Desyrel ) venlafaxine (Effexor ) vilazodone (Viibryd ) vortioxetine (Brintellix ) ziprasidone (Geodon ) The GeneSight patient report will show commonly prescribed psychiatric medications that are grouped into 1 of 3 color-coded categories, based on your own unique genomic profile. GREEN YELLOW RED Medications may be used as directed Use medications with caution Use medications with increased caution and with more frequent monitoring 6 5
5 How How do do I I join join the the study? study? For more information about the study and to see if you qualify, please contact: 2014 AssureRx Health, Inc. Assurex Health is a DBA of AssureRx Health, Inc. Assurex and GeneSight are trademarks of AssureRx Health, Inc. All other product names are trademarks of their respective owners. All rights reserved. Printed in the USA.
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