Pharmacogenetic Testing on an Outpatient Population With a Depression Diagnosis

Major Depressive Disorder Clinical Trial

— PGX-AMG  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02443584
• Other study ID #: AIHG-1430-PGxAMG
• Status: Completed
• Phase: N/A
• First received: February 6, 2015
• Last updated: May 2, 2017
• Start date: February 1, 2015
• Est. completion date: April 1, 2017

Study information

• Verified date: May 2017
• Source: Avera McKennan Hospital & University Health Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: April 1, 2017
• Est. primary completion date: April 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Other:
• pharmacogenetic testing
pharmacogenetic testing for anti-depressant/anti-psychotic medications

Locations

Country	Name	City	State
United States	Avera McKennan Hospital & University Health Center	Sioux Falls	South Dakota

Sponsors (1)

Lead Sponsor	Collaborator
Avera McKennan Hospital & University Health Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical outcomes (response to medication following medication recommendation guided by pharmacogenetic testing)	response to medication following medication recommendation guided by pharmacogenetic testing	24 weeks
Secondary	Clinical utility (Utilization by physicians in following medication recommendations guided by pharmacogenetic testing)	Utilization by physicians in following medication recommendations guided by pharmacogenetic testing	24 weeks

External Links

•   Avera Research Institute website