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
  Purpose

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.


Condition Intervention
Depression
Other: Algorithm

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 227
Study Start Date: January 2009
Study Completion Date: May 2013
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Algorithm
Algorithm provided to physician to assist with medication decisions.
Other: Algorithm
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  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.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Daniel K. Hall-Flavin, PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01610063     History of Changes
Other Study ID Numbers: 08-005610
Study First Received: May 25, 2012
Last Updated: May 8, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Algorithm
Depression

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014