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

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ClinicalTrials.gov Identifier: NCT02497027
Recruitment Status : Completed
First Posted : July 14, 2015
Last Update Posted : May 3, 2017
Sponsor:
Information provided by (Responsible Party):
Avera McKennan Hospital & University Health Center

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).

Condition or disease Intervention/treatment Phase
Depression Other: pharmacogenetic testing Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 83 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Pharmacogenetic Testing in an Outpatient Population of Patients With Major Depressive Disorder or Depressive Disorder Not Otherwise Specified
Study Start Date : February 2015
Actual Primary Completion Date : April 1, 2017
Actual Study Completion Date : April 1, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

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 12 weeks post enrollment




Primary Outcome Measures :
  1. Depression score [ Time Frame: 24 weeks ]
    response to medication following medication recommendation guided by pharmacogenetic testing


Secondary Outcome Measures :
  1. Clinical utility questionnaire [ Time Frame: 24 weeks ]
    This will be assessed through review of medical records and a study compliance questionnaire to be completed by the prescribing physician



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02497027


Locations
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United States, South Dakota
Avera McKennan Hospital & University Health Center
Sioux Falls, South Dakota, United States, 57105
Sponsors and Collaborators
Avera McKennan Hospital & University Health Center
Investigators
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Principal Investigator: Matthew Stanley, MD Avera McKennan Hospital & University Health Center

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Responsible Party: Avera McKennan Hospital & University Health Center
ClinicalTrials.gov Identifier: NCT02497027     History of Changes
Other Study ID Numbers: AIHG-1440-PGxUPA
First Posted: July 14, 2015    Key Record Dates
Last Update Posted: May 3, 2017
Last Verified: May 2017

Keywords provided by Avera McKennan Hospital & University Health Center:
pharmacogenetic, pharmacogenomic, depressive, mental health

Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders