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

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ClinicalTrials.gov Identifier: NCT02443584
Recruitment Status : Completed
First Posted : May 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
Major Depressive Disorder Other: pharmacogenetic testing Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 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 With Avera Medical Group Clinics
Actual Study Start Date : February 1, 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 for anti-depressant/anti-psychotic medications

12-Week Group
Pharmacogenetic testing released to physician at 12 weeks following enrollment into study
Other: pharmacogenetic testing
pharmacogenetic testing for anti-depressant/anti-psychotic medications




Primary Outcome Measures :
  1. Clinical outcomes (response to medication following medication recommendation guided by pharmacogenetic testing) [ Time Frame: 24 weeks ]
    response to medication following medication recommendation guided by pharmacogenetic testing


Secondary Outcome Measures :
  1. Clinical utility (Utilization by physicians in following medication recommendations guided by pharmacogenetic testing) [ Time Frame: 24 weeks ]
    Utilization by physicians in following medication recommendations guided by pharmacogenetic testing



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

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

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): NCT02443584


Locations
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
Principal Investigator: Matthew Stanley, MD Avera McKennan Hospital & University Health Center

Additional Information:
Responsible Party: Avera McKennan Hospital & University Health Center
ClinicalTrials.gov Identifier: NCT02443584     History of Changes
Other Study ID Numbers: AIHG-1430-PGxAMG
First Posted: May 14, 2015    Key Record Dates
Last Update Posted: May 3, 2017
Last Verified: May 2017

Keywords provided by Avera McKennan Hospital & University Health Center:
depression
pharmacogenetics
pharmacogenomics
major depressive disorder
genetics
anti-depressants

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