Genomics Used to Improve DEpression Decisions

NCT02109939 | Completed Results

• 1 other identifier: ARX1006
• Study Type: interventional
• Target: 1,398
• Locations: 1 country
• Sites: 61

Brief Summary

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.

Conditions

Major Depressive Disorder (MDD)

Keywords

MDD; Pharmacogenomic; Pharmacogenomic Testing; Pharmacogenomics; Genetic Testing; Genetics; Major Depressive Disorder; GeneSight; Assurex; AssureRx; Psychotropic; Randomized; Double Blind; Placebo Controlled

Outcome Measures

Primary Outcomes (1)

• Percent Change in the 17-item Hamilton Depression (HAM-D17) Score From Baseline to 8 Weeks

  Evaluate the impact of GeneSight Psychotropic on response to psychotropic treatment as judged by the mean percent change in the 17-item Hamilton Depression (HAM-D17) score from baseline to end of Week 8 of the study. Scores range from 0 to 50, and lower scores are better outcomes. Percent change is defined as (week 8 score -baseline score) / (baseline score) x 100.

  from baseline to end of Week 8

Secondary Outcomes (22)

• Percent Change in the 16-item Quick Inventory of Depression Symptomology (QIDS-C16) Score From Baseline to 8 Weeks

  from baseline to end of Week 8

• Percentage of Responders at Week 8 for HAM-D17

  Week 8 visit info

• Percentage of Responders at Week 12 for HAM-D17

  Week 12 visit info

• Percentage of Remitters at Week 12 Defined as HAM-D17 ≤7

  week 12 visit info

• Percentage of Remitters at Week 8 Defined as HAM-D17 ≤7 Each Treatment Group;

  week 8 visit info

Other Outcomes (3)

• Generalized Anxiety Disorder 7-item (GAD-7) Scale

  week 12 to week 24

• Generalized Anxiety Disorder 7-item (GAD-7) Scale

  baseline to week 8

• Generalized Anxiety Disorder 7-item (GAD-7) Scale

  baseline to week 12

Study Arms (2)

GeneSight Psychotropic Tested

ACTIVE COMPARATOR

Subjects being tested with GeneSight Psychotropic

Genetic: GeneSight Psychotropic

Treatment As Usual

PLACEBO COMPARATOR

This group of subjects will not see their GeneSIght results or know whether or not they are in either arm until after week 12.

Genetic: GeneSight Psychotropic

Interventions

GeneSight Psychotropic GENETIC

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.

Also known as: Assurex Health, GeneSight

GeneSight Psychotropic Tested; Treatment As Usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• Delirium
• Dementia
• Amnestic and other cognitive disorder
• 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;

Sponsors & Collaborators

• Assurex Health Inc.: lead
• University of Michigan: collaborator

Study Sites (61)

Birmingham Psychiatry Pharmaceutical Studies

Birmingham, Alabama, 35226, United States

Location

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

CiTrials

Bellflower, California, 90706, United States

Location

Catalina Research Institute

Chino, California, 91710, United States

Location

CiTrials

Costa Mesa, California, 92705, United States

Location

Synergy Research Center

Escondido, California, 92025, United States

Location

Pharmacology Research Institute

Los Alamitos, California, 90720, United States

Location

North County Research

Oceanside, California, 92056, United States

Location

CiTrials

Riverside, California, 92506, United States

Location

Stanford School of Medicine

Stanford, California, 94304, United States

Location

Viking Clinical Research

Temecula, California, 92591, United States

Location

Elite Clinical Trials, Inc

Wildomar, California, 92595, United States

Location

MCB Clinical Research Centers, LLC

Colorado Springs, Colorado, 80910, United States

Location

Howard University Hospital Mental Health Clinic

Washington D.C., District of Columbia, 20060, United States

Location

Sarkis Clinical Trials

Gainesville, Florida, 32607, United States

Location

Clinical Neuroscience Solutions Healthcare

Jacksonville, Florida, 32256, United States

Location

Clinical Neuroscience Solutions

Orlando, Florida, 32801, United States

Location

Clinical Research Trials of Florida, Inc

Tampa, Florida, 33607, United States

Location

Stedman Clinical Trials

Tampa, Florida, 33613, United States

Location

Janus Center For Psychiatric Research

West Palm Beach, Florida, 33407, United States

Location

Atlanta Institute of Medicine and Research

Atlanta, Georgia, 30328, United States

Location

Mood and Anxiety Program at Emory University

Atlanta, Georgia, 30329, United States

Location

Meridian Clinical Research

Savannah, Georgia, 31406, United States

Location

Carman Research

Smyrna, Georgia, 30080, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Behavioral Healthcare Associates

Schaumburg, Illinois, 60194, United States

Location

The Institute of Psychiatric Research

Indianapolis, Indiana, 46202, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Kansas University Medical Center- Clinical Trials Unit

Wichita, Kansas, 67214, United States

Location

Pharmasite Research

Baltimore, Maryland, 21208, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21224, United States

Location

Geriatric Outpatient Unit- McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

Boston Clinical Trials

Boston, Massachusetts, 02131, United States

Location

UMASS Center for Psychopharmacologic Research and Treatment

Worcester, Massachusetts, 01655, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55454, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

PsychCare Consultants Research

St Louis, Missouri, 63128, United States

Location

Meridian Clinical Research

Bellevue, Nebraska, 68005, United States

Location

Premier Psychiatric Research Institute, LLC

Lincoln, Nebraska, 68526, United States

Location

United Medical Research Associates

Binghamton, New York, 13901, United States

Location

Integrative Clinical Trials, LLC

Brooklyn, New York, 11229, United States

Location

SPRI Clinical Trials

Brooklyn, New York, 11235, United States

Location

Eastside Comprehensive Medical Center, LLC

New York, New York, 10021, United States

Location

Finger Lakes Clinical Research

Rochester, New York, 14618, United States

Location

University of Cincinnati Health

Cincinnati, Ohio, 45267, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44120, United States

Location

Ohio State University Department of Psychiatry

Columbus, Ohio, 43210, United States

Location

Midwest Clinical Research Center

Dayton, Ohio, 45417, United States

Location

Oklahoma Clinical Research Center

Oklahoma City, Oklahoma, 73112, United States

Location

Summit Research Network

Portland, Oregon, 97210, United States

Location

Suburban Research Associates

Media, Pennsylvania, 19063, United States

Location

Mood and Anxiety Disorders Treatment and Research

Philadelphia, Pennsylvania, 19104, United States

Location

Lincoln Research

Lincoln, Rhode Island, 02865, United States

Location

Clinical Neuroscience Solutions

Memphis, Tennessee, 38119, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 76034, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Alliance Research Group

Richmond, Virginia, 20230, United States

Location

Northwest Clinical Research Center

Bellevue, Washington, 98007, United States

Location

Summit Research Network

Seattle, Washington, 98104, United States

Location

Frontier Institute

Spokane, Washington, 99204, United States

Location

Related Publications (3)

• Dunlop BW, Parikh SV, Rothschild AJ, Thase ME, DeBattista C, Conway CR, Forester BP, Mondimore FM, Shelton RC, Macaluso M, Logan J, Traxler P, Li J, Johnson H, Greden JF. Comparing sensitivity to change using the 6-item versus the 17-item Hamilton depression rating scale in the GUIDED randomized controlled trial. BMC Psychiatry. 2019 Dec 27;19(1):420. doi: 10.1186/s12888-019-2410-2.

  PMID: 31881956 DERIVED

• Thase ME, Parikh SV, Rothschild AJ, Dunlop BW, DeBattista C, Conway CR, Forester BP, Mondimore FM, Shelton RC, Macaluso M, Li J, Brown K, Jablonski MR, Greden JF. Impact of Pharmacogenomics on Clinical Outcomes for Patients Taking Medications With Gene-Drug Interactions in a Randomized Controlled Trial. J Clin Psychiatry. 2019 Oct 31;80(6):19m12910. doi: 10.4088/JCP.19m12910.

  PMID: 31721487 DERIVED

• Greden JF, Parikh SV, Rothschild AJ, Thase ME, Dunlop BW, DeBattista C, Conway CR, Forester BP, Mondimore FM, Shelton RC, Macaluso M, Li J, Brown K, Gilbert A, Burns L, Jablonski MR, Dechairo B. Impact of pharmacogenomics on clinical outcomes in major depressive disorder in the GUIDED trial: A large, patient- and rater-blinded, randomized, controlled study. J Psychiatr Res. 2019 Apr;111:59-67. doi: 10.1016/j.jpsychires.2019.01.003. Epub 2019 Jan 4.

  PMID: 30677646 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: Lindsey Burns
• Organization: Assurex Health

lindsey.burns@myriad.com

5137015068

Study Officials

• John Greden, Ph.D

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2014
• First Posted: April 10, 2014
• Study Start: April 1, 2014
• Primary Completion: April 20, 2017
• Study Completion: July 31, 2017
• Last Updated: January 14, 2020
• Results First Posted: January 14, 2020

Record last verified: 2020-01

Locations

US (61)