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OpenTrials
Completed

NCT Number: NCT02443584

Pharmacogenetic Testing on an Outpatient Population With a Depression Diagnosis

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Avera McKennan Hospital & University Health Center

Sioux Falls, South Dakota, 57105, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pharmacogenetic testing

Other

pharmacogenetic testing for anti-depressant/anti-psychotic medications

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Avera McKennan Hospital & University Health Center

Other

Registry information

Official study title

Pharmacogenetic Testing in an Outpatient Population of Patients With Major Depressive Disorder or Depressive Disorder Not Otherwise Specified With Avera Medical Group Clinics

Acronym: PGX-AMG

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
May 14, 2015
Registry last updated
May 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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