A Pilot Study for the Evaluation of the Clinic-wide Impact of the Antidepressant Pharmacogenomic Algorithm in an Outpatient Clinical Setting
While the ultimate goal of this project is to show an improvement in patient outcomes, this pilot study will be used to evaluate the feasibility of introducing the pharmacogenomic algorithm to a new setting that does not routinely use the algorithm. Secondary outcome data will be collected to generate meaningful estimates of the magnitude of potential treatment effects. The trial is designed to occur within the Franciscan Skemp Healthcare System in La Crosse, Wisconsin and Arcadia, Wisconsin over the course of 12 months. A novel method of delivering the genetic testing results to the physician will be utilized and evaluated. This novel method is a system which will deliver results faster and give more guidance for the selection of medication.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||A Pilot Study for the Evaluation of the Clinic-wide Impact of the Antidepressant Pharmacogenomic Algorithm in an Outpatient Clinical Setting|
- Proportion of time physician prescribed medication [ Time Frame: eight weeks ] [ Designated as safety issue: No ]
- Percentage of patients approached who consent to use of the pharmacogenomic algorithm
- Amount of time from ordering of test to receipt of results
- Proportion of time that the physician prescribed a medication that was recommended by the algorithm.
- Physician and patient satisfaction [ Time Frame: eight weeks ] [ Designated as safety issue: No ]
- Time to remission of depressive symptoms
- Measured side effect burden
- Number of participants who change their initial medication regimen.
- Health care clinical cost
- Physician satisfaction with delivery of clinical care
- Patient satisfaction with clinical care
|Study Start Date:||January 2009|
|Study Completion Date:||May 2013|
|Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
Algorithm provided to physician to assist with medication decisions.
Genetic test results was put through algorithm and provided to physician for guidance prescribing medication.
No Intervention: No Algorithm
Algorithm was not provided until after the eight weeks of study.
Antidepressant medications are among the most widely prescribed medications. However, only 35% to 45% of depressed patients have a complete remission of their illness when initially treated with these medications. Consequently, the Mayo Clinic psychiatric pharmacogenomic team has developed a pharmacogenomic algorithm that has been designed to improve the effectiveness and safety of antidepressant medications by providing guidance in medication selection and appropriate dosing. This algorithm has been incorporated into a new genotyping interpretative report. This report is now available from AssureRx. The pharmacogenomic algorithm is based on genotyping both copies of four informative genes. These four genes are: 1) the Cytochrome P450 2D6 gene; 2) the Cytochrome P450 2C19 gene; 3) the Serotonin Transporter gene (SLC6A4); and 4) the Serotonin 2A receptor gene (5HTR2A). Though this algorithm is not yet part of the universal standard of care, Mayo clinicians have found it helpful in guiding treatment decisions at Mayo Clinic Rochester.