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

NCT ID: NCT02479464

Last Updated: 2019-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2014-08-31

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.

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.

Conditions

Major Depressive Disorder

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Part 1

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Part 2

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

Group Type: OTHER

Genotyping results

Intervention Type: GENETIC

Genotyping results provided in Phase II

Interventions

Genotyping results

Genotyping results provided in Phase II

Intervention Type: GENETIC

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AssureRx Health, Inc.

INDUSTRY

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Daniel K. Hall-Flavin

Associate Professor of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

09-002523

Identifier Type: -

Identifier Source: org_study_id