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

NCT02474680 | Completed DMC

• 1 other identifier: AIHG-1420-PGxTIME
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder 1

Keywords

depression; Major Depressive Disorder; MDD; mental health; pharmacogenomics; personalized medicine; precision medicine; anti-depressants

Outcome Measures

Primary Outcomes (1)

• Depression scores

  Compare depression scores at baseline and following pharmacogenetic-guided medication recommendation

  12 months

Secondary Outcomes (1)

• Economic impact of pharmacogenetic testing

  12 months

Study Arms (1)

Care Coordination Group

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

Genetic: Pharmacogenetic testing

Interventions

Pharmacogenetic testing GENETIC

Psychotropic genotyping panel

Care Coordination Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants must be enrolled in the Avera Care Coordination Program and have insurance coverage through the Avera Health Plans

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Avera McKennan Hospital & University Health Center: lead

Study Sites (1)

Avera Institute for Human Genetics

Sioux Falls, South Dakota, 57108, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

serum

MeSH Terms

Conditions

Major Depressive Disorder 1; Depression; Depressive Disorder, Major; Psychological Well-Being

Interventions

Pharmacogenomic Testing

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders; Mental Disorders; Personal Satisfaction

Intervention Hierarchy (Ancestors)

Genetic Testing; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Genetic Techniques; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Diagnostic Services; Preventive Health Services

Study Officials

• Matthew Stanely, MD

  Avera McKennan Hospital & University Health Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2015
• First Posted: June 18, 2015
• Study Start: November 1, 2015
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: May 3, 2017

Record last verified: 2017-05

Locations

US (1)