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

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

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).

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Other: pharmacogenetic testing

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 Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57105
      • Avera McKennan Hospital & University Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical outcomes (response to medication following medication recommendation guided by pharmacogenetic testing)	response to medication following medication recommendation guided by pharmacogenetic testing	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical utility (Utilization by physicians in following medication recommendations guided by pharmacogenetic testing)	Utilization by physicians in following medication recommendations guided by pharmacogenetic testing	24 weeks

Collaborators and Investigators

• Sponsor: Avera McKennan Hospital & University Health Center
• Investigators: Principal Investigator: Matthew Stanley, MD, Avera McKennan Hospital & University Health Center

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2015
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: February 6, 2015
• First Submitted That Met QC Criteria: May 11, 2015
• First Posted (Estimate): May 14, 2015

Study Record Updates

• Last Update Posted (Actual): May 3, 2017
• Last Update Submitted That Met QC Criteria: May 2, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: pharmacogenetics; genetics; depression; major depressive disorder; pharmacogenomics; anti-depressants
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: AIHG-1430-PGxAMG