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
1 other identifier
observational
104
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2011
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 27, 2012
CompletedFirst Posted
Study publicly available on registry
July 2, 2012
CompletedResults Posted
Study results publicly available
March 22, 2013
CompletedJanuary 5, 2016
February 1, 2013
3 months
June 27, 2012
February 14, 2013
December 4, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Number of Medical Absence Days
During the one year study window (April 1, 2010 to April 1, 2011)
Number of Disability Claims
During the one year study window (April 1, 2010 to April 1, 2011)
Study Arms (1)
Depression and anxiety
Subjects with a primary diagnosis of depression or anxiety disorder.
Eligibility Criteria
Subjects under the care of a psychiatrist at Union Health Services, Chicago, IL
You may qualify if:
- 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
You may not qualify if:
- Bipolar Disorder
- Schizophrenia
- Schizoaffective Disorder
- Previous pharmacogenomic testing
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Union Health Services
Chicago, Illinois, 60612, United States
Biospecimen
Buccal samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Joel Winner, MD
- Organization
- AssureRx
Study Officials
- PRINCIPAL INVESTIGATOR
Aida Spahic-Mihajlovic, MD
Union Health Services
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 27, 2012
First Posted
July 2, 2012
Study Start
January 1, 2011
Primary Completion
April 1, 2011
Study Completion
September 1, 2011
Last Updated
January 5, 2016
Results First Posted
March 22, 2013
Record last verified: 2013-02