PGX-AMG: Pharmacogenetic Testing on an Outpatient Population With a Depression Diagnosis

Sponsor

Avera McKennan Hospital & University Health Center (Other)

Overall Status

Completed

CT.gov ID

NCT02443584

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a randomized, control group design of pharmacogenetic implementation in a mental health population of subjects taking anti-depressants and/or anti-psychotics with a new or current primary or secondary diagnosis of Major Depressive Disorder (MDD) or Depressive Disorder Not Otherwise Specified (DDNOS).

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder	Other: pharmacogenetic testing	N/A

Detailed Description

Mental illness affects one in four adults in the United States; approximately 61.5 million Americans experience mental illness in a given year. According to the National Alliance for the Mentally Ill, the impact of serious mental illness costs Americans $193.2 billion in lost earnings per year. In addition, mental illness patients have an increased risk of having chronic medical conditions, leading to increased costs and emergency service utilization for those conditions. In addition to substantial costs, patients with psychiatric illness are difficult to treat. More than two-thirds of patients with depression do not respond to first line therapy. Treatment often involves numerous trials of individual agents and combinations of medications in order to achieve optimal response. Pharmacogenetic testing is being used in more settings to guide treatment decisions.

Study Design

Study Type:

Interventional

Actual Enrollment :

84 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Supportive Care

Official Title:

Pharmacogenetic Testing in an Outpatient Population of Patients With Major Depressive Disorder or Depressive Disorder Not Otherwise Specified With Avera Medical Group Clinics

Actual Study Start Date :

Feb 1, 2015

Actual Primary Completion Date :

Apr 1, 2017

Actual Study Completion Date :

Apr 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Other: 4-Week Group Pharmacogenetic testing released to physician at 4 weeks following enrollment into study	Other: pharmacogenetic testing pharmacogenetic testing for anti-depressant/anti-psychotic medications
Other: 12-Week Group Pharmacogenetic testing released to physician at 12 weeks following enrollment into study	Other: pharmacogenetic testing pharmacogenetic testing for anti-depressant/anti-psychotic medications

Arm

Intervention/Treatment

Other: 4-Week Group

Pharmacogenetic testing released to physician at 4 weeks following enrollment into study

Other: pharmacogenetic testing

pharmacogenetic testing for anti-depressant/anti-psychotic medications

Other: 12-Week Group

Pharmacogenetic testing released to physician at 12 weeks following enrollment into study

Other: pharmacogenetic testing

pharmacogenetic testing for anti-depressant/anti-psychotic medications

Outcome Measures

Primary Outcome Measures

Clinical outcomes (response to medication following medication recommendation guided by pharmacogenetic testing) [24 weeks]
response to medication following medication recommendation guided by pharmacogenetic testing

Secondary Outcome Measures

Clinical utility (Utilization by physicians in following medication recommendations guided by pharmacogenetic testing) [24 weeks]
Utilization by physicians in following medication recommendations guided by pharmacogenetic testing

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Current primary or secondary diagnosis of Major Depressive Disorder or Depressive Disorder Not Otherwise Specified
Have moderate to severe depression as identified by PHQ-9 scoring of 10 or greater
Taking or be newly prescribed an anti-depressant or anti-psychotic medication
Able to provide informed consent

Exclusion Criteria:

Pregnant or breastfeeding
Active and/or unstable diagnosis of substance abuse, excluding nicotine
Primary diagnosis of dementia, bipolar disorder (any type), schizophrenia, schioaffective disorder, or personality disorder