Evaluation of Pharmacogenetic Testing In a Mental Health... | NCT02474680

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

NCT02474680

Sponsor

Avera McKennan Hospital & University Health Center

Status

Completed

Last Update Posted

May 3, 2017Actual

Enrollment

84Actual

Phase

Not provided

Conditions

Major Depressive Disorder 1

Interventions

Pharmacogenetic testing

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2015Actual

Primary Completion Date

Jan 1, 2017Actual

Completion Date

Jan 1, 2017Actual

First Submitted Date

Feb 5, 2015

First Submission Date that Met QC Criteria

Jun 15, 2015

First Posted Date

Jun 18, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 2, 2017

Last Update Posted Date

May 3, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

84Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Care Coordination Group		Patients participating in the Avera Care Coordination Program for Intervention 'Pharmacogenetic testing'	Genetic: Pharmacogenetic testing

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pharmacogenetic testing	Genetic	Psychotropic genotyping panel	Care Coordination Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Depression scores	Compare depression scores at baseline and following pharmacogenetic-guided medication recommendation	12 months

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Matthew Stanely, MD	Avera McKennan Hospital & University Health Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Avera Institute for Human Genetics		Sioux Falls	South Dakota	57108	United States

Condition Browse Module

MeSH Terms

ID	Term
C563919	Major Depressive Disorder 1
D003863	Depression
D003865	Depressive Disorder, Major
D000092862	Psychological Well-Being

Ancestor Terms

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior
D003866	Depressive Disorder
D019964	Mood Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000071185	Pharmacogenomic Testing

Ancestor Terms

ID	Term
D005820	Genetic Testing
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided