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

Major Depressive Disorder 1 Clinical Trial

— PGx-TIME  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02474680
• Other study ID #: AIHG-1420-PGxTIME
• Status: Completed
• Phase: N/A
• First received: February 5, 2015
• Last updated: May 2, 2017
• Start date: November 1, 2015
• Est. completion date: January 1, 2017

Study information

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

Clinical Trial 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.

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.

Recruitment information / eligibility

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

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder 1

Intervention

Genetic:
• Pharmacogenetic testing
Psychotropic genotyping panel

Locations

Country	Name	City	State
United States	Avera Institute for Human Genetics	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 scores	Compare depression scores at baseline and following pharmacogenetic-guided medication recommendation	12 months
Secondary	Economic impact of pharmacogenetic testing	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.	12 months

External Links

•   Avera Institute for Human Genetics