Clinical trial NCT01610063: Evaluation of an Antidepressant Pharmacogenomic Algorithm in an Outpatient Clinical Setting
Official title: A Pilot Study for the Evaluation of the Clinic-wide Impact of the Antidepressant Pharmacogenomic Algorithm in an Outpatient Clinical Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Algorithm
Depression
Assurex
GeneSight
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Assurex Health Home
First posted: 2012-06-01
Enrollment: 227
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Percentage Change in Quick Inventory of Depressive Symptomatology (QIDS-C16) Score From Baseline
timeFrame: baseline, 8-week visit
Secondary outcomes:
measure: Percentage Change in Hamilton Depression Rating Scale (HAMD-17) Score From Baseline
timeFrame: baseline, 8-week visit
measure: Percentage Change in Patient Health Questionnaire-9 (PHQ-9) Score From Baseline
timeFrame: baseline, 8-week visit
measure: Percentage Change in Outcome by Bin Status and Treatment Group
timeFrame: baseline, 8-week visit
measure: Pharmacogenomic Report Utilization
timeFrame: baseline, 8-week visit
measure: Physicians' Perception of Participant's Satisfaction With Their Care
timeFrame: 8-week visit
measure: Responders at Week 8
timeFrame: baseline, 8 weeks
measure: Remitters at Week 8
timeFrame: baseline, 8 weeks
Other outcomes:
Locations:
city: La Crosse
country: United States
facility: Franciscan Skemp HealthCare
state: Wisconsin
Study officials:
affiliation: Mayo Clinic
name: Daniel K. Hall-Flavin
role: PRINCIPAL_INVESTIGATOR
References: