Pharmacogenetic Testing in an Outpatient Population of Patients With Major Depressive Disorder or Depressive Disorder Not Otherwise Specified
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 83
- Locations
- 2
- Primary Endpoint
- Depression score
Study Overview
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).
Detailed Description
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). Prospective data will be collected on all subjects until study completion at 24-25 weeks post enrollment. Claims data may be reviewed per pay, if such data are readily available in a timely manner.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
- •Prescribing physician practices at the Avera Medical Group University Psychiatry Associates clinic in Sioux Falls, SD
Exclusion Criteria
- •Pregnant or breastfeeding
- •Active and/or unstable diagnosis of substance abuse, excluding nicotine
- •Primary diagnosis of dementia, bipolar disorder (any type), schizophrenia, schizoaffective disorder, or personality disorder
Outcomes
Primary Outcomes
Depression score
Time Frame: 24 weeks
response to medication following medication recommendation guided by pharmacogenetic testing
Secondary Outcomes
- Clinical utility questionnaire(24 weeks)