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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02479464
Recruitment Status : Completed
First Posted : June 24, 2015
Last Update Posted : July 3, 2015
AssureRx Health, Inc.
Information provided by (Responsible Party):
Daniel K. Hall-Flavin, Mayo Clinic

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Genetic: Genotyping results Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: A Pilot Study for the Evaluation of the Clinical Impact of the Antidepressant Pharmacogenomic Algorithm in an Outpatient Therapy-based Clinical Setting
Study Start Date : October 2009
Actual Primary Completion Date : September 2010
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antidepressants

Arm Intervention/treatment
No Intervention: Part 1
This is the treatment as usual arm to monitor the current standard clinical practice
Part 2
This group will be provided with genotyping results after baseline visit to guide clinical medication management
Genetic: Genotyping results
Genotyping results provided in Phase II

Primary Outcome Measures :
  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 Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patient is between the ages of 18 and 80.
  2. Major depressive disorder or depressive disorder not otherwise specified (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
  4. Patient's Hamilton Depression Rating score is >14
  5. Patient is being seen by a psychiatrist for optimum medication management.
  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)

Responsible Party: Daniel K. Hall-Flavin, Associate Professor of Psychiatry, Mayo Clinic Identifier: NCT02479464     History of Changes
Other Study ID Numbers: 09-002523
First Posted: June 24, 2015    Key Record Dates
Last Update Posted: July 3, 2015
Last Verified: July 2015

Keywords provided by Daniel K. Hall-Flavin, Mayo Clinic:
Major depressive disorder

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Antidepressive Agents
Psychotropic Drugs