Pharmacogenetic Testing in an Outpatient Population of Patients With Depression (PGx-UPA)
Primary Purpose
Depression
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
pharmacogenetic testing
pharmacogenetic testing
Sponsored by
About this trial
This is an interventional supportive care trial for Depression focused on measuring pharmacogenetic, pharmacogenomic, depressive, mental health
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
- 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
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
Depression score
response to medication following medication recommendation guided by pharmacogenetic testing
Secondary Outcome Measures
Clinical utility questionnaire
This will be assessed through review of medical records and a study compliance questionnaire to be completed by the prescribing physician
Full Information
NCT ID
NCT02497027
First Posted
June 15, 2015
Last Updated
May 2, 2017
Sponsor
Avera McKennan Hospital & University Health Center
1. Study Identification
Unique Protocol Identification Number
NCT02497027
Brief Title
Pharmacogenetic Testing in an Outpatient Population of Patients With Depression
Acronym
PGx-UPA
Official Title
Pharmacogenetic Testing in an Outpatient Population of Patients With Major Depressive Disorder or Depressive Disorder Not Otherwise Specified
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
pharmacogenetic, pharmacogenomic, depressive, mental health
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
83 (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 report released to physician at 4 weeks post enrollment
Intervention Type
Other
Intervention Name(s)
pharmacogenetic testing
Intervention Description
pharmacogenetic testing report released to physician at 12 weeks post enrollment
Primary Outcome Measure Information:
Title
Depression score
Description
response to medication following medication recommendation guided by pharmacogenetic testing
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Clinical utility questionnaire
Description
This will be assessed through review of medical records and a study compliance questionnaire to be completed by the prescribing physician
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
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
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 in an Outpatient Population of Patients With Depression
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