Evaluation of Pharmacogenetic Testing In a Mental Health Population and Economic Outcomes

Completed

• Conditions: Major Depressive Disorder 1
• Interventions: Genetic: Pharmacogenetic testing

• Registration Number: NCT02474680
• Lead Sponsor: Avera McKennan Hospital & University Health Center

Brief Summary

This is a non-randomized, single-case design of pharmacogenetic implementation in a mental health patient population of subjects taking antipsychotics and/or antidepressants.

Detailed Description

This is a non-randomized, single-case design of pharmacogenetic implementation in a mental health patient population of subjects taking antipsychotics and/or antidepressants. Retrospective and prospective data will be collected on all subjects before and after pharmacogenetic recommendations have been made. Retrospective data will be collected for the previous 12 months before pharmacogenetic recommendations are made and prospective data will be collected for 12 months after pharmacogenomic recommendations have been made.

Study Timeline

• Study First Submitted: 2015-02-05
• Study First Submitted QC: 2015-06-15
• Study First Posted: 2015-06-18
• Study Start: 2015-11-01
• Primary Completion: 2017-01-01
• Study Completion: 2017-01-01
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-02
• Last Update Posted: 2017-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

• Must be taking either an anti-depressant or an anti-psychotic medication
• Must provide informed consent
• Must have Avera Health Plans insurance coverage
• Must have three months of participation in the Avera Care Coordination Program

Exclusion Criteria

• Must not be pregnant or breastfeeding
• Must not have an active and/or unstable diagnosis of substance abuse
• Must not have a primary diagnosis of dementia, bulimia, or anorexia nervosa disorder
• Must not have had a previous pharmacogenetic evaluation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Care Coordination Group	Pharmacogenetic testing	Patients participating in the Avera Care Coordination Program for Intervention 'Pharmacogenetic testing'

Primary Outcome Measures

Name	Time	Method
Depression scores	12 months	Compare depression scores at baseline and following pharmacogenetic-guided medication recommendation

Secondary Outcome Measures

Name	Time	Method
Economic impact of pharmacogenetic testing	12 months	Data from patients' insurance provider will be compared pre- and post-pharmacogenetic testing. Such data may include hospitalizations, clinic visits, ER visits, medication expenses, etc.

Trial Locations

Locations (1)

Avera Institute for Human Genetics; 🇺🇸 Sioux Falls, South Dakota, United States