Pharmacogenetic Testing in an Outpatient Population of Patients With Depression

Not Applicable

Completed

• Conditions: Depression
• Interventions: Other: pharmacogenetic testing

• Registration Number: NCT02497027
• Lead Sponsor: 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).

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.

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-06-15
• Study First Submitted QC: 2015-07-13
• Study First Posted: 2015-07-14
• Primary Completion: 2017-04-01
• Study Completion: 2017-04-01
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-02
• Last Update Posted: 2017-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 83

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
12-Week Group	pharmacogenetic testing	Pharmacogenetic testing released to physician at 12 weeks following enrollment into study
4-Week Group	pharmacogenetic testing	Pharmacogenetic testing released to physician at 4 weeks following enrollment into study

Primary Outcome Measures

Name	Time	Method
Depression score	24 weeks	response to medication following medication recommendation guided by pharmacogenetic testing

Secondary Outcome Measures

Name	Time	Method
Clinical utility questionnaire	24 weeks	This will be assessed through review of medical records and a study compliance questionnaire to be completed by the prescribing physician

Trial Locations

Locations (1)

Avera McKennan Hospital & University Health Center; 🇺🇸 Sioux Falls, South Dakota, United States