Pharmacogenetic Testing on an Outpatient Population With a Depression Diagnosis
PGX-AMG
Pharmacogenetic Testing in an Outpatient Population of Patients With Major Depressive Disorder or Depressive Disorder Not Otherwise Specified With Avera Medical Group Clinics
1 other identifier
interventional
84
1 country
1
Brief Summary
This is a randomized, control group design of pharmacogenetic implementation in a mental health population of subjects taking anti-depressants and/or anti-psychotics with a new or current primary or secondary diagnosis of Major Depressive Disorder (MDD) or Depressive Disorder Not Otherwise Specified (DDNOS).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable major-depressive-disorder
Started Feb 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 6, 2015
CompletedFirst Posted
Study publicly available on registry
May 14, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2017
CompletedMay 3, 2017
May 1, 2017
2.2 years
February 6, 2015
May 2, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical outcomes (response to medication following medication recommendation guided by pharmacogenetic testing)
response to medication following medication recommendation guided by pharmacogenetic testing
24 weeks
Secondary Outcomes (1)
Clinical utility (Utilization by physicians in following medication recommendations guided by pharmacogenetic testing)
24 weeks
Study Arms (2)
4-Week Group
OTHERPharmacogenetic testing released to physician at 4 weeks following enrollment into study
12-Week Group
OTHERPharmacogenetic testing released to physician at 12 weeks following enrollment into study
Interventions
pharmacogenetic testing for anti-depressant/anti-psychotic medications
Eligibility Criteria
You may qualify if:
- Current primary or secondary diagnosis of Major Depressive Disorder or Depressive Disorder Not Otherwise Specified
- Have moderate to severe depression as identified by PHQ-9 scoring of 10 or greater
- Taking or be newly prescribed an anti-depressant or anti-psychotic medication
- Able to provide informed consent
You may not qualify if:
- Pregnant or breastfeeding
- Active and/or unstable diagnosis of substance abuse, excluding nicotine
- Primary diagnosis of dementia, bipolar disorder (any type), schizophrenia, schioaffective disorder, or personality disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Avera McKennan Hospital & University Health Center
Sioux Falls, South Dakota, 57105, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Matthew Stanley, MD
Avera McKennan Hospital & University Health Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 6, 2015
First Posted
May 14, 2015
Study Start
February 1, 2015
Primary Completion
April 1, 2017
Study Completion
April 1, 2017
Last Updated
May 3, 2017
Record last verified: 2017-05