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Completed

NCT Number: NCT01632267

Retrospective Analysis of Outcomes With a Pharmacogenomic Algorithm

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.

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Key information

Conditions

Depression Anxiety Anxiety Disorders Behavior Behavioral Symptoms Mental Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Union Health Services

Chicago, Illinois, 60612, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Assurex Health Inc.

Industry

Registry information

Official study title

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

Acronym: UHS

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jul 2, 2012
Registry last updated
Jan 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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