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

Major Depressive Disorder Clinical Trial

— HAMM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02479464
• Other study ID #: 09-002523
• Status: Completed
• Phase: N/A
• Start date: October 2009
• Est. completion date: August 2014

Study information

• Verified date: May 2019
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2014
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Genetic:
• Genotyping results
Genotyping results provided in Phase II

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	AssureRx Health, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients approached who consent to use of pharmacogenomic algorithm		8 weeks
Primary	Amount of time from ordering test to receipt of results		8 weeks
Primary	Proportion of time that the physician prescribed a medication that was recommended by the algorithm		8 weeks
Secondary	Time to remission of depressive symptoms	Hamilton rating of < 7	8 weeks
Secondary	Measured side effect burden	Reduction in Frequency, Intensity, and Burden of Side Effects Rating (FIBSER) score.	8 weeks
Secondary	Number of participants who change their initial medication regimen		8 weeks
Secondary	Health care clinical cost	defined by analysis of mental health resource utilization	8 weeks
Secondary	Physician satisfaction with delivery of clinical care	defined by researcher developed Likert-based satisfaction survey	8 weeks
Secondary	Patient satisfaction with clinical care	defined by researcher developed Likert-based satisfaction survey	8 weeks

External Links

•   Mayo Clinic Clinical Trials