Retrospective Analysis of Outcomes With a Pharmacogenomic Algorithm (UHS)
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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 |
- 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
- 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 |
Subjects under the care of a psychiatrist at Union Health Services, Chicago, IL
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 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:
|
Anxiety Disorders Depression Depressive Disorder Depressive Disorder, Major |
Mental Disorders Behavioral Symptoms Mood Disorders |
ClinicalTrials.gov processed this record on May 22, 2013