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Retrospective Analysis of Outcomes With a Pharmacogenomic Algorithm (UHS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01632267
Recruitment Status : Completed
First Posted : July 2, 2012
Results First Posted : March 22, 2013
Last Update Posted : January 5, 2016
Information provided by (Responsible Party):
Assurex Health Inc.

Brief Summary:
Antidepressants are among the most widely prescribed medications, yet only 35-45% of patients achieve remission following an initial antidepressant trial. The financial burden of treatment failures in direct treatment costs, disability, decreased productivity, and missed work may in part derive from a mismatch between optimal, and actual, medications prescribed. The present one year retrospective study seeks to evaluate the indirect and direct healthcare costs for 96 patients with a DSM-IV-TR depressive or anxiety disorder, in relation to an interpretive reporting system designed to predict antidepressant responses based on DNA variations in cytochrome P450 genes (CYP2D6, CYP2C19, CYP1A2), the serotonin transporter gene (SLC6A4), and the serotonin 2A receptor (5HTR2A) genes.

Condition or disease
Depression Anxiety

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Study Type : Observational
Actual Enrollment : 104 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Retrospective Analysis of Outcomes in Outpatients With Major Depressive Disorder (MDD) in a Staff Model HMO: Pharmacogenetic Algorithm for Psychotropic Pharmacotherapeutic Applications
Study Start Date : January 2011
Actual Primary Completion Date : April 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Depression and anxiety
Subjects with a primary diagnosis of depression or anxiety disorder.

Primary Outcome Measures :
  1. Number of Outpatient Visits [ Time Frame: During the one year study window (April 1, 2010 to April 1, 2011) ]
    Number of outpatient healthcare visits during study window

Secondary Outcome Measures :
  1. Number of Medical Absence Days [ Time Frame: During the one year study window (April 1, 2010 to April 1, 2011) ]
    Number of medical absence days during study window

  2. Number of Disability Claims [ Time Frame: During the one year study window (April 1, 2010 to April 1, 2011) ]
    Number of disabiity claims during study window

Biospecimen Retention:   Samples With DNA
Buccal samples

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Subjects under the care of a psychiatrist at Union Health Services, Chicago, IL

Inclusion Criteria:

  • Major Depressive Disorder
  • Dysthymic Disorder
  • Depressive Disorder NOS
  • Obsessive Compulsive Disorder (OCD)
  • Generalized Anxiety Disorder
  • Panic Disorder
  • Anxiety Disorder NOS
  • Post-Traumatic Stress Disorder (PTSD)
  • Social Phobia

Exclusion Criteria:

  • Bipolar Disorder
  • Schizophrenia
  • Schizoaffective Disorder
  • Previous pharmacogenomic testing

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 identifier (NCT number): NCT01632267

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United States, Illinois
Union Health Services
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Assurex Health Inc.
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Principal Investigator: Aida Spahic-Mihajlovic, MD Union Health Services

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Responsible Party: Assurex Health Inc. Identifier: NCT01632267     History of Changes
Other Study ID Numbers: 10003
First Posted: July 2, 2012    Key Record Dates
Results First Posted: March 22, 2013
Last Update Posted: January 5, 2016
Last Verified: February 2013

Additional relevant MeSH terms:
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Behavioral Symptoms