Retrospective Analysis of Outcomes With a Pharmacogenomic Algorithm (UHS)

A Retrospective Analysis of Outcomes in Outpatients With Major Depressive Disorder (MDD) in a Staff Model HMO: Pharmacogenetic Algorithm for Psychotropic Pharmacotherapeutic Applications

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 Overview

• Status: Completed
• Conditions: Depression; Anxiety

• Study Type: Observational
• Enrollment (Actual): 104

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Union Health Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Subjects under the care of a psychiatrist at Union Health Services, Chicago, IL

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Depression and anxiety; Subjects with a primary diagnosis of depression or anxiety disorder.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Outpatient Visits	Number of outpatient healthcare visits during study window	During the one year study window (April 1, 2010 to April 1, 2011)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Medical Absence Days	Number of medical absence days during study window	During the one year study window (April 1, 2010 to April 1, 2011)
Number of Disability Claims	Number of disabiity claims during study window	During the one year study window (April 1, 2010 to April 1, 2011)

Collaborators and Investigators

• Sponsor: Assurex Health Inc.
• Investigators: Principal Investigator: Aida Spahic-Mihajlovic, MD, Union Health Services

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): April 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: June 27, 2012
• First Submitted That Met QC Criteria: June 28, 2012
• First Posted (Estimate): July 2, 2012

Study Record Updates

• Last Update Posted (Estimate): January 5, 2016
• Last Update Submitted That Met QC Criteria: December 4, 2015
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: 10003