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

NCT02479464 | Completed

• 1 other identifier: 09-002523
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Major Depressive Disorder

Keywords

AssureRx; Algorithm; Major depressive disorder

Outcome Measures

Primary Outcomes (3)

• Percentage of patients approached who consent to use of pharmacogenomic algorithm

  8 weeks

• Amount of time from ordering test to receipt of results

  8 weeks

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

  8 weeks

Secondary Outcomes (6)

• Time to remission of depressive symptoms

  8 weeks

• Measured side effect burden

  8 weeks

• Number of participants who change their initial medication regimen

  8 weeks

• Health care clinical cost

  8 weeks

• Physician satisfaction with delivery of clinical care

  8 weeks

Study Arms (2)

Part 1

NO INTERVENTION

This is the treatment as usual arm to monitor the current standard clinical practice

Part 2

OTHER

This group will be provided with genotyping results after baseline visit to guide clinical medication management

Genetic: Genotyping results

Interventions

Genotyping results GENETIC

Genotyping results provided in Phase II

Part 2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Mayo Clinic: lead
• AssureRx Health, Inc.: collaborator

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry

Study Record Dates

• First Submitted: June 16, 2015
• First Posted: June 24, 2015
• Study Start: October 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: August 1, 2014
• Last Updated: May 21, 2019

Record last verified: 2019-05