A Pilot Study for the Evaluation of the Clinic-wide Impact of the Antidepressant Pharmacogenomic Algorithm in an Outpatient Clinical Setting
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mayo Clinic
- Enrollment
- 227
- Locations
- 2
- Primary Endpoint
- Percentage Change in Quick Inventory of Depressive Symptomatology (QIDS-C16) Score From Baseline
Study Overview
Brief Summary
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..
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient is between the ages of 18 and
- •Major depressive disorder or depressive disorder not otherwise specified as ascertained by a physician or mental health professional licensed to diagnose.
- •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.
- •Patient has been referred to see a psychiatrist for optimum medication management.
- •Patient's Hamilton Depression Rating score is >14
- •Ability to read, understand and sign an informed consent document
Exclusion Criteria
- •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)
Outcomes
Primary Outcomes
Percentage Change in Quick Inventory of Depressive Symptomatology (QIDS-C16) Score From Baseline
Time Frame: baseline, 8-week visit
The QIDS-C16 is a 16-item scale that is clinician-rated; it is designed to assess the severity of depressive symptoms. The QIDS-C16 total score ranges from 0-27. Scores ranging from 0 to 10 correspond with no to mild depression, while scores \>/= 11 correspond to moderate to severe depression. A negative change indicates improvement in the subject's depression, and a positive change indicates a worsening of the subject's depression.
Secondary Outcomes
- Percentage Change in Hamilton Depression Rating Scale (HAMD-17) Score From Baseline(baseline, 8-week visit)
- Physicians' Perception of Participant's Satisfaction With Their Care(8-week visit)
- Responders at Week 8(baseline, 8 weeks)
- Percentage Change in Patient Health Questionnaire-9 (PHQ-9) Score From Baseline(baseline, 8-week visit)
- Percentage Change in Outcome by Bin Status and Treatment Group(baseline, 8-week visit)
- Remitters at Week 8(baseline, 8 weeks)
- Pharmacogenomic Report Utilization(baseline, 8-week visit)
Investigators
Daniel K. Hall-Flavin
PI
Mayo Clinic