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

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
pharmacogenetic testing
Sponsored by
Avera McKennan Hospital & University Health Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Major Depressive Disorder focused on measuring depression, pharmacogenetics, pharmacogenomics, major depressive disorder, genetics, anti-depressants

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Avera McKennan Hospital & University Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

4-Week Group

12-Week Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Clinical outcomes (response to medication following medication recommendation guided by pharmacogenetic testing)
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)
Utilization by physicians in following medication recommendations guided by pharmacogenetic testing

Full Information

First Posted
February 6, 2015
Last Updated
May 2, 2017
Sponsor
Avera McKennan Hospital & University Health Center
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1. Study Identification

Unique Protocol Identification Number
NCT02443584
Brief Title
Pharmacogenetic Testing on an Outpatient Population With a Depression Diagnosis
Acronym
PGX-AMG
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
February 1, 2015 (Actual)
Primary Completion Date
April 1, 2017 (Actual)
Study Completion Date
April 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Avera McKennan Hospital & University Health Center

4. Oversight

Data Monitoring Committee
Yes

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
depression, pharmacogenetics, pharmacogenomics, major depressive disorder, genetics, anti-depressants

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
4-Week Group
Arm Type
Other
Arm Description
Pharmacogenetic testing released to physician at 4 weeks following enrollment into study
Arm Title
12-Week Group
Arm Type
Other
Arm Description
Pharmacogenetic testing released to physician at 12 weeks following enrollment into study
Intervention Type
Other
Intervention Name(s)
pharmacogenetic testing
Intervention Description
pharmacogenetic testing for anti-depressant/anti-psychotic medications
Primary Outcome Measure Information:
Title
Clinical outcomes (response to medication following medication recommendation guided by pharmacogenetic testing)
Description
response to medication following medication recommendation guided by pharmacogenetic testing
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Clinical utility (Utilization by physicians in following medication recommendations guided by pharmacogenetic testing)
Description
Utilization by physicians in following medication recommendations guided by pharmacogenetic testing
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Stanley, MD
Organizational Affiliation
Avera McKennan Hospital & University Health Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Avera McKennan Hospital & University Health Center
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States

12. IPD Sharing Statement

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Pharmacogenetic Testing on an Outpatient Population With a Depression Diagnosis

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