Evaluation of an Antidepressant Pharmacogenomic Algorithm in an Outpatient Clinical Setting

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

227 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2013-05-31

Brief Summary

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This was a study of a genotyping tool that reported on how subjects responded to medications and could be used in a community psychiatry practice to improve medication choice for depression. After the DNA test, an interpretive report was provided to the subjects' physicians. The hypothesis of this pilot study was that it was feasible to use this pharmacogenomic algorithm in a new setting to treat depressed subjects..

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Detailed Description

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Antidepressant medications are among the most widely prescribed medications. However, only 35% to 45% of depressed patients have a complete remission of their illness when initially treated with these medications. Consequently, the Mayo Clinic psychiatric pharmacogenomic team developed a pharmacogenomic algorithm 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. 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). The trial took place at the Franciscan Skemp Healthcare System in La Crosse, Wisconsin over the course of 12 months.

Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Guided

A pharmacogenomic algorithm (GeneSight) guided treatment decisions for antidepressant medication selection and appropriate dosing.

Group Type EXPERIMENTAL

Pharmacogenomic algorithm

Intervention Type OTHER

Genetic test results for 4 genes were put through algorithm and provided to physician for guidance prescribing medication.

Unguided

Treatment as usual

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Pharmacogenomic algorithm

Genetic test results for 4 genes were put through algorithm and provided to physician for guidance prescribing medication.

Intervention Type OTHER

Other Intervention Names

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GeneSight

Eligibility Criteria

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Inclusion Criteria

1. Patient is between the ages of 18 and 80.
2. Major depressive disorder or depressive disorder not otherwise specified 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, or a discharging inpatient with scheduled follow-up with a Behavioral Health psychiatrist.
4. Patient has been referred to see a psychiatrist for optimum medication management.
5. Patient's Hamilton Depression Rating score is \>14
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