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A Pilot Study for the Evaluation of the Clinic-wide Impact of the Antidepressant Pharmacogenomic Algorithm in an Outpatient Clinical Setting

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Daniel K. Hall-Flavin, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01610063
First received: May 25, 2012
Last updated: May 8, 2013
Last verified: May 2013

May 25, 2012
May 8, 2013
January 2009
November 2011   (final data collection date for primary outcome measure)
Proportion of time physician prescribed medication [ Time Frame: eight weeks ] [ Designated as safety issue: No ]
  1. Percentage of patients approached who consent to use of the pharmacogenomic algorithm
  2. Amount of time from ordering of test to receipt of results
  3. Proportion of time that the physician prescribed a medication that was recommended by the algorithm.
Same as current
Complete list of historical versions of study NCT01610063 on ClinicalTrials.gov Archive Site
Physician and patient satisfaction [ Time Frame: eight weeks ] [ Designated as safety issue: No ]
  1. Time to remission of depressive symptoms
  2. Measured side effect burden
  3. Number of participants who change their initial medication regimen.
  4. Health care clinical cost
  5. Physician satisfaction with delivery of clinical care
  6. Patient satisfaction with clinical care
Same as current
Not Provided
Not Provided
 
A Pilot Study for the Evaluation of the Clinic-wide Impact of the Antidepressant Pharmacogenomic Algorithm in an Outpatient Clinical Setting
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Depression
Other: Algorithm
Genetic test results was put through algorithm and provided to physician for guidance prescribing medication.
  • Experimental: Algorithm
    Algorithm provided to physician to assist with medication decisions.
    Intervention: Other: Algorithm
  • No Intervention: No Algorithm
    Algorithm was not provided until after the eight weeks of study.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
227
May 2013
November 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Patient is between the ages of 18 and 80.
  2. Major depressive disorder or depressive disorder NOS as ascertained by a physician or mental health professional licensed to diagnose.
  3. Patient is an outpatient and not in imminent need of inpatient hospitalization, or a discharging inpatient with scheduled follow-up with an FSH Behavioral Health psychiatrist.
  4. Patient has been referred to see a psychiatrist for optimum medication management.
  5. Patient's Hamilton Depression Rating score is >14
  6. Ability to read, understand and sign an informed consent document

Exclusion Criteria:

  1. Serious medical illness (as ascertained via the initial triage screening process)
  2. Patients with a diagnosis of Bipolar I disorder
  3. Patients with a diagnosis of Schizophrenia or Schizoaffective disorder
  4. Patients who are legally unable to consent to enrollment in the study (i.e. patients with legal guardians)
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01610063
08-005610
No
Daniel K. Hall-Flavin, Mayo Clinic
Mayo Clinic
Not Provided
Not Provided
Mayo Clinic
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP