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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
Avera McKennan Hospital & University Health Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Depression focused on measuring pharmacogenetic, pharmacogenomic, depressive, mental health

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
  • 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

First Posted
June 15, 2015
Last Updated
May 2, 2017
Sponsor
Avera McKennan Hospital & University Health Center
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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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