Pharmacogenetic Testing in an Outpatient Population of Patients With Depression (PGx-UPA)

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

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: Depression
• Intervention / Treatment: Other: pharmacogenetic testing; Other: pharmacogenetic testing

Detailed Description

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). Prospective data will be collected on all subjects until study completion at 24-25 weeks post enrollment. Claims data may be reviewed per pay, if such data are readily available in a timely manner.

• Study Type: Interventional
• Enrollment (Actual): 83
• 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
• Prescribing physician practices at the Avera Medical Group University Psychiatry Associates clinic in Sioux Falls, SD

Exclusion Criteria:

• Pregnant or breastfeeding
• Active and/or unstable diagnosis of substance abuse, excluding nicotine
• Primary diagnosis of dementia, bipolar disorder (any type), schizophrenia, schizoaffective 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 report released to physician at 4 weeks post enrollment; Other: pharmacogenetic testing; pharmacogenetic testing report released to physician at 12 weeks post enrollment
Other: 12-Week Group; Pharmacogenetic testing released to physician at 12 weeks following enrollment into study	Other: pharmacogenetic testing; pharmacogenetic testing report released to physician at 4 weeks post enrollment; Other: pharmacogenetic testing; pharmacogenetic testing report released to physician at 12 weeks post enrollment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression score	response to medication following medication recommendation guided by pharmacogenetic testing	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical utility questionnaire	This will be assessed through review of medical records and a study compliance questionnaire to be completed by the prescribing physician	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: February 1, 2015
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: June 15, 2015
• First Submitted That Met QC Criteria: July 13, 2015
• First Posted (Estimate): July 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: pharmacogenetic, pharmacogenomic, depressive, mental health
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: AIHG-1440-PGxUPA