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WIRB 20140530 #11880047.0

Genetic Testing help you find the •Mm

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right medication for your

depression?

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.

"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

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: •

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.

Psychotropic

GeneSight® Clinical Study: The Details

How does the study work? 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. • 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 week period. • The group whose clinicians do not receive GeneSight results until the end of the 12 week period. 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 week period.

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

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The GeneSight Report

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GeneSight Psychotropic Results

Patient, Sample DOB 7/22/1984

Antidepressants USE AS DIRECTED bupropion (Wellbutrin®) desvenlafaxine (Pristiq®) selegiline (Emsam®) (Viibryd®)

USE WITH CAUTION amitriptyline (Elavil®) [2] citalopram (Celexa®) [3] clomipramine (Anafranil®) [2,7 doxepin (Sinequan®) [2] escitalopram (Lexapro®) [3] imipramine (Tofranil®) [3] (Zoloft®) [3] (Desyrel®) [2]

USE WITH INCREASED CAUTION AND WITH MORE FREQUENT MONITORING desipramine (Norpramin®) [2] duloxetine (CymOalta®) [2,7] fluoxetine (Prozac®) [2] fluvoxamine (Luvox®) [2,7] mirtazapine (Remeron®) [2,7] nortriptyline (Pamelor®) [2] paroxetine (Paxil®) [2,4,6 venlafaxine (Effexor®) [3]

Antipsychotics USE AS DIRECTED fluphenazine (Prolixin®) lurasidone (Latuda®) paliperidone (Invega®) ziprasidone (Geodon®)

USE WITH CAUTION

USE WITH INCREASED CAUTION AND WITH MORE FREQUENT MONITORING aripiprazole (Abilify®) [2] chlorpromazine (Thorazine®) [2 clozapine (Clozaril®) [2,7] haloperidol (Haldol®) [2] iloperidone (Fanapt®) [2] olanzapine (Zyprexa®) [2,7] perphenazine (Trilafon®) [2,7] risperidone (Risperdal®) [2] (Mellaril®) [2,7]

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

Medications may be used as directed

YELLOW

Use medications with caution

RED

Use medications with increased caution and with more frequent monitoring

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Medications included on the GeneSight report

amitriptyline (Elavil®)

levomilnacipran (Fetzima®

aripiprazole (Abilify®)

lurasidone (Latuda®)

asenapine (Saphris®)

mirtazapine (Remeron®)

bupropion (Wellbutrin®)

nortriptyline (Pamelor®)

chlorpromazine (Thorazine®)

olanzapine (Zyprexa®) paliperidone (Invega®)

citalopram (Celexa®) clomipramine (Anafranil®)

perphenazine (Trilafon®)

clozapine (Clozaril®) desipramine (Norpramin®) desvenlafaxine (Pristiq®) doxepin (Sinequan®) duloxetine (Cymbalta®) escitalopram (Lexapro®) fluoxetine (Prozac®) fluphenazine (Prolixin®) fluvoxamine (Luvox®) haloperidol (Haldol®) iloperidone (Fanapt®) imipramine (Tofranil®)

paroxetine (Paxil®)

quetiapine (Seroquel®) risperidone (Risperdal®) selegiline (Emsam®) sertraline (Zoloft®) thioridazine (Mellaril®) thiothixene (Navane®) trazodone (Desyrel®) venlafaxine (Effexor®) vilazodone (Viibryd®) vortioxetine (Brintellix®) ziprasidone (Geodon®)

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How do I join the study?

For more information about the study and to see if you qualify, please contact:

insert IRB statement

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