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

NCT ID: NCT02474680

Last Updated: 2017-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

84 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-11-01

Study Completion Date

2017-01-01

Brief Summary

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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

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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.

Conditions

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Major Depressive Disorder 1

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Care Coordination Group

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

Pharmacogenetic testing

Intervention Type GENETIC

Psychotropic genotyping panel

Interventions

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Pharmacogenetic testing

Psychotropic genotyping panel

Intervention Type GENETIC

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Avera McKennan Hospital & University Health Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matthew Stanely, MD

Role: PRINCIPAL_INVESTIGATOR

Avera McKennan Hospital & University Health Center

Locations

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Avera Institute for Human Genetics

Sioux Falls, South Dakota, United States

Site Status

Countries

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United States

Other Identifiers

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AIHG-1420-PGxTIME

Identifier Type: -

Identifier Source: org_study_id

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