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Retrospective Analysis of Outcomes With a Pharmacogenomic Algorithm (UHS)

This study has been completed.
Information provided by (Responsible Party):
Assurex Health Inc. Identifier:
First received: June 27, 2012
Last updated: December 4, 2015
Last verified: February 2013
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.


Study Type: Observational
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Assurex Health Inc.:

Primary Outcome Measures:
  • 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:
  • 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

  • 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

Enrollment: 104
Study Start Date: January 2011
Study Completion Date: September 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Depression and anxiety
Subjects with a primary diagnosis of depression or anxiety disorder.


Ages Eligible for Study:   18 Years to 65 Years   (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
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Please refer to this study by its identifier: NCT01632267

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

Responsible Party: Assurex Health Inc. Identifier: NCT01632267     History of Changes
Other Study ID Numbers: 10003
Study First Received: June 27, 2012
Results First Received: February 14, 2013
Last Updated: December 4, 2015 processed this record on April 26, 2017