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Retrospective Analysis of Outcomes With a Pharmacogenomic Algorithm (UHS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AssureRx
ClinicalTrials.gov Identifier:
NCT01632267
First received: June 27, 2012
Last updated: February 14, 2013
Last verified: February 2013
  Purpose

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.


Condition
Depression
Anxiety

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 AssureRx:

Primary Outcome Measures:
  • Number of Outpatient Visits [ Time Frame: During the one year study window (April 1, 2010 to April 1, 2011) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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)
Groups/Cohorts
Depression and anxiety
Subjects with a primary diagnosis of depression or anxiety disorder.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01632267

Locations
United States, Illinois
Union Health Services
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
AssureRx
Investigators
Principal Investigator: Aida Spahic-Mihajlovic, MD Union Health Services
  More Information

No publications provided

Responsible Party: AssureRx
ClinicalTrials.gov Identifier: NCT01632267     History of Changes
Other Study ID Numbers: 10003
Study First Received: June 27, 2012
Results First Received: February 14, 2013
Last Updated: February 14, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Depression
Behavioral Symptoms

ClinicalTrials.gov processed this record on November 25, 2014