Genomics Used to Improve DEpression Decisions



Status:Completed
Conditions:Depression, Depression, Major Depression Disorder (MDD), Psychiatric
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - Any
Updated:6/2/2018
Start Date:April 2014
End Date:July 31, 2017

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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

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.

Major depressive disorder (MDD) is a highly prevalent (Hasin et al., 2005) mental disorder
and a leading source of disease burden worldwide (Lopez et al., 2006). Epidemiological
studies estimate 12-month and lifetime prevalence for MDD in the United States to be 5.3% and
13.2%, respectively (reviewed in Blanco et al., 2010). MDD is expected to be the second
greatest cause of disability by 2020 and has been shown to cause significant morbidity,
affecting people's ability to work, function in relationships, and engage in social
activities. Moreover, MDD increases the risk of suicidal ideation, attempted suicide, and
death by completed suicide.

Prospective longitudinal studies of patient samples show that MDD is a chronic illness,
characterized by remitting and recurrent depressive episodes (Solomon et al., 1997; Mueller
et al., 1999). A major depressive episode is characterized by a low mood or an inability to
experience pleasure (anhedonia), or both, for more than 2 weeks, combined with several
cognitive and vegetative symptoms and the occurrence of distress or impairment (reviewed in
Rot et al., 2009). In the US, nearly 1 in 5 people will experience a major depressive episode
at some point in their lives (reviewed in Rot et al., 2009). Drugs currently available to
treat depression fall into the categories of those that have their main effect by increasing
norepinephrine (NE) (the tricyclic or tetracyclic antidepressants [TCAs]), those that
increase serotonin (5-HT) (the selective serotonin reuptake inhibitors [SSRIs]), and those
that increase both NE and 5-HT (the monoamine oxidase inhibitors [MAOIs] and the serotonin
and norepinephrine reuptake inhibitors [SNRIs]). While all antidepressants achieve similar
levels of efficacy, treatment failures are relatively high ranging from 30 to 60% (Simpson
and DePaulo). Additionally, many of these compounds are associated with significant adverse
events (AEs).

The 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 in multiple 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.

The clinical utility of GeneSight Psychotropic has been evaluated in three previous
prospective trials. Hall-Flavin et al reported the results of an open-label pilot study (n =
44) comparing GeneSight guided treatment to treatment as usual (TAU) without the benefit of
pharmacogenomic testing (2012). The GeneSight guided arm demonstrated a 30.8% improvement in
HAM-D17 score by the end of the 8 week treatment period, compared to an 18.2% improvement in
the TAU arm (p = 0.04). Results of the larger (n = 165) open-label trial (Hall-Flavin, et al
2013) mirrored these findings, demonstrating a 46.9% improvement in HAMD17 score in the
GeneSight arm, compared to a 29.9% improvement in the TAU arm (p < 0.0001). The third trial
used a randomized, double-blind trial design (n = 51). Due to the small sample size, the
trial was underpowered to detect a significant difference in improvement between the two arms
(TAU and GeneSight). However, effect sizes of improvement reflected those seen in previous
trials. The GeneSight group experienced a 30.8% improvement in HAMD17, compared to 20.7% in
TAU. Odds ratios for response were calculated, showing that GeneSight-guided subjects had a
2.14 times greater likelihood of response compared to TAU subjects, which was similar to the
4.67 (smaller trial) and 2.06 (larger trial) odds ratios calculated for the other two
studies.

Previous studies utilizing an open-label design have shown significant improvement in patient
outcomes following use of the GeneSight test. However, although effect sizes were similar to
those seen in the open-label studies, a small (n = 51) blinded, randomized controlled trial
did not detect a statistically significant outcome. Therefore, the primary rationale for this
trial is to replicate previous findings of improvement in clinical outcomes in subjects
treated with the benefit of GeneSight testing utilizing a double-blind, randomized control
trial (RCT) design.

It is expected that results from this trial will be used to inform guidelines for the use of
pharmacogenomic testing for the treatment of major depressive disorder. Results may also be
shared with regulatory bodies in the United States and abroad.

Inclusion 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
each patient 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 weeks of 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:

1. Delirium

2. Dementia

3. Amnestic and other cognitive disorder

4. Schizophrenia or other psychotic disorder;

- 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 the liver; 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 prior to screening; malignancy more than 1 year prior to screening must
have been local and without metastasis and/or recurrence, and if treated with
chemotherapy, without nervous 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;

- 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.
We found this trial at
61
sites
2713 West Virginia Avenue
Tampa, Florida 33607
(813) 873-8102
Principal Investigator: Sady A Alipzar
Phone: 813-873-8102
Clinical Research Trials of Florida, Inc (CRTFI) is located across of St Joseph Hospital the...
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Birmingham, AL
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Principal Investigator: Amit Anand, MD
Phone: 216-636-2841
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Cleveland, OH
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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Houston, TX
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Minneapolis, Minnesota 55455
(612) 625-5000
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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Minneapolis, MN
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3212 Cutshaw Ave
Richmond, Virginia 23230
804-353-4494
Principal Investigator: Prakash Ettigi, M.D.
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Richmond, VA
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3212 Cove Bend Drive
Tampa, Florida 33613
Principal Investigator: Mary L Stedman, M.D.
Phone: 813-971-8311
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5601 Corporate Way
West Palm Beach, Florida 33407
561-238-3036
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West Palm Beach, FL
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
University of Michigan The University of Michigan was founded in 1817 as one of the...
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12 Executive Park Drive Northeast
Atlanta, Georgia 30329
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Baltimore, Maryland 21208
Principal Investigator: Robert B Lehman, M.D.
Phone: 410-602-1440
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1800 Orleans St.
Baltimore, Maryland 21287
410-955-5000
Principal Investigator: Peter Zandi, PhD
Phone: 410-614-2686
Johns Hopkins Hospital Patients are the focus of everything we do at The Johns Hopkins...
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Baltimore, MD
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Bellevue, Nebraska 68005
Principal Investigator: James Cervantes, MD
Phone: 402-916-9840
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Bellevue, Washington 98007
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Bellflower, California 90706
Principal Investigator: Myron Reiff, MD
Phone: 562-748-4999
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Belmont, Massachusetts 02478
Principal Investigator: Brent Forester, MD
Phone: 617-855-3492
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Binghamton, New York 13901
Principal Investigator: Frank S Eder, MD
Phone: 607-771-1064
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Birmingham, Alabama 35226
Principal Investigator: James Hall, MD
Phone: 205-978-7840
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Boston, Massachusetts 02135
Principal Investigator: Irina Mezhebovsky, M.D.
Phone: 617-477-4868
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Brooklyn, New York 11229
Principal Investigator: Inna Yuryev-Golger, M.D.
Phone: 718-444-7774
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Brooklyn, New York 11235
Principal Investigator: Nick Vatakis, MD
Phone: 718-616-2230
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Principal Investigator: Corey Goldstein, MD
Phone: 773-330-4332
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Chino, California 91710
Principal Investigator: Gilbert Martinez, M.D.
Phone: 909-203-4700
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Cincinnati, Ohio 45267
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Colorado Springs, Colorado 80910
Principal Investigator: Andrew Sedillo, MD
Phone: 719-634-6576
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Columbus, OH
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Costa Mesa, California 92626
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1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
Principal Investigator: Mustafa Husain, MD
Phone: 214-648-2806
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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Escondido, California 92025
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Gainesville, Florida 32607
Principal Investigator: Elias H Sarkis, M.D.
Phone: 352-333-0094
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Indianapolis, Indiana 46202
Principal Investigator: John Nurnberger, Ph.D, M.D
Phone: 317-274-8844
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Indianapolis, IN
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200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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Jacksonville, Florida 32256
Principal Investigator: Mark Joyce, M.D.
Phone: 904-281-5757
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Lincoln, Nebraska 68510
Principal Investigator: Walter Duffy, MD
Phone: 402-817-2235
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Lincoln, Rhode Island 02865
Principal Investigator: James Whalen, MD
Phone: 401-333-3435
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Los Alamitos, California 90720
Principal Investigator: Nader Oskooilar, MD
Phone: 714-827-3667
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Media, Pennsylvania 19063
Principal Investigator: Shirkumar Hatti, M.D.
Phone: 610-891-9024
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Memphis, Tennessee 38119
Principal Investigator: Valerie Arnold, MD
Phone: 901-843-1045
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New York, New York 10021
Principal Investigator: Ram Shrivastava, MD
Phone: 212-288-0138
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Oceanside, California 92056
Principal Investigator: Valentin Isacescu, M.D.
Phone: 760-639-4378
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Oklahoma City, Oklahoma 73112
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Orlando, Florida 32806
Principal Investigator: Linda S Harper, M.D.
Phone: 407-425-5100
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Philadelphia, Pennsylvania 19104
Principal Investigator: Michael Thase, MD
Phone: 215-746-6680
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Portland, Oregon 97210
Principal Investigator: Alan Yeo, M.D.
Phone: 503-972-9812
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Riverside, California 92506
Principal Investigator: Rajagopal Sunder, MD
Phone: 951-300-4924
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Rochester, New York 14618
Principal Investigator: Sarah D Atkinson, MD
Phone: 585-241-9670
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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5000 Cedar Plaza Parkway
Saint Louis, Missouri 63128
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Savannah, Georgia 31406
Principal Investigator: Steven K Corse, MD
Phone: 912-443-4253
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Schaumburg, Illinois 60194
Principal Investigator: Blaise Wolfrum
Phone: 847-895-4540
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Seattle, Washington 98104
Principal Investigator: Jerry Steiert, M.D.
Phone: 206-624-4587
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Smyrna, Georgia 30080
Principal Investigator: Nathan Shapira, MD, PhD
Phone: 770-333-0093
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Spokane, Washington 99204
Principal Investigator: John Tran, MD
Phone: 509-710-8750
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Stanford, California 94305
Principal Investigator: Charles DeBattista, MD
Phone: 650-723-8324
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Temecula, California 92591
Principal Investigator: Sana Johnson-Quijada, M.D.
Phone: 951-695-6238
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Washington, District of Columbia 20060
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Wichita, Kansas 67214
Principal Investigator: Matthew Macaluso, D.O.
Phone: 316-293-1833
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Wildomar, California 92595
Principal Investigator: Eliot Moon, M.D.
Phone: 951-678-1551
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