Pharmacogenetic Testing in an Outpatient Population of Patients With Depression

Depression Clinical Trial

— PGx-UPA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02497027
• Other study ID #: AIHG-1440-PGxUPA
• Status: Completed
• Phase: N/A
• First received: June 15, 2015
• Last updated: May 2, 2017
• Start date: February 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:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• 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

• 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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Other:
• pharmacogenetic testing
pharmacogenetic testing report released to physician at 4 weeks post enrollment
• pharmacogenetic testing
pharmacogenetic testing report released to physician at 12 weeks post enrollment

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	Depression score	response to medication following medication recommendation guided by pharmacogenetic testing	24 weeks
Secondary	Clinical utility questionnaire	This will be assessed through review of medical records and a study compliance questionnaire to be completed by the prescribing physician	24 weeks