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Completed

NCT Number: NCT02479464

Clinical Impact of the Antidepressant Pharmacogenomic Algorithm in an Outpatient Therapy-based Clinical Setting

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.

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Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

The proposed pilot study is designed to evaluate the clinical impact of the interpretive report in an outpatient behavioral health clinic in St. Paul, Minnesota. 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 study will consist of two phases, each enrolling 2530 subjects. In Phase 1, consecutive patients will be prospectively monitored to observe standard practice. Patients will be given the option to receive genotyping and those that agree will have blood drawn. However, the results of the genotyping and algorithm will not be released until all phase 1 patients have completed study visits.. Subsequently, in Phase 2, also enrolling 3025 subjects, the results of the genotyping and algorithm will be made available immediately for additional consecutive prospectively monitored patients. Patients will be prospectively monitored in the same fashion as Phase 1. The results of the study will be used to perform preliminary analyses and subsequent fully powered multi-site trials will be planned based on the results of this study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient is between the ages of 18 and 80.
  • Major depressive disorder or depressive disorder not otherwise specified (NOS) as ascertained by a physician or mental health professional licensed to diagnose.
  • Patient is an outpatient and not in imminent need of inpatient hospitalization
  • Patient's Hamilton Depression Rating score is >14
  • Patient is being seen by a psychiatrist for optimum medication management.
  • Ability to read, understand and sign an informed consent document

Exclusion criteria

  • Serious medical illness (as ascertained via the initial triage screening process)
  • Patients with a diagnosis of Bipolar I disorder
  • Patients with a diagnosis of Schizophrenia or Schizoaffective disorder
  • Patients who are legally unable to consent to enrollment in the study (i.e. patients with legal guardians)

Treatment and study plan

Genotyping results

Genetic

Genotyping results provided in Phase II

Primary outcomes

  1. Percentage of patients approached who consent to use of pharmacogenomic algorithm

    Time frame: 8 weeks

  2. Amount of time from ordering test to receipt of results

    Time frame: 8 weeks

  3. Proportion of time that the physician prescribed a medication that was recommended by the algorithm

    Time frame: 8 weeks

Secondary outcomes

  1. Time to remission of depressive symptoms

    Time frame: 8 weeks

    Hamilton rating of < 7

  2. Measured side effect burden

    Time frame: 8 weeks

    Reduction in Frequency, Intensity, and Burden of Side Effects Rating (FIBSER) score.

  3. Number of participants who change their initial medication regimen

    Time frame: 8 weeks

  4. Health care clinical cost

    Time frame: 8 weeks

    defined by analysis of mental health resource utilization

  5. Physician satisfaction with delivery of clinical care

    Time frame: 8 weeks

    defined by researcher developed Likert-based satisfaction survey

  6. Patient satisfaction with clinical care

    Time frame: 8 weeks

    defined by researcher developed Likert-based satisfaction survey

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • AssureRx Health, Inc.

Registry information

Official study title

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

Acronym: HAMM

Important dates

Study start
2009
Primary completion
2010
Study completion
2014
First posted
Jun 24, 2015
Registry last updated
May 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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