Retrospective Analysis of Outcomes With a Pharmacogenomic Algorithm

Completed

• Conditions: Depression; Anxiety

• Registration Number: NCT01632267
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2011-04
• Study Completion: 2011-09
• Study First Submitted: 2012-06-27
• Study First Submitted QC: 2012-06-28
• Study First Posted: 2012-07-02
• Status Verified: 2013-02
• Results First Submitted: 2013-02-14
• Results First Submitted QC: 2013-02-14
• Results First Posted: 2013-03-22
• Last Update Submitted: 2015-12-04
• Last Update Posted: 2016-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Outpatient Visits	During the one year study window (April 1, 2010 to April 1, 2011)	Number of outpatient healthcare visits during study window

Secondary Outcome Measures

Name	Time	Method
Number of Medical Absence Days	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	During the one year study window (April 1, 2010 to April 1, 2011)	Number of disabiity claims during study window

Trial Locations

Locations (1)

Union Health Services; 🇺🇸 Chicago, Illinois, United States