Depression
Conditions
Keywords
pharmacogenetic, pharmacogenomic, depressive, mental health
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.
Interventions
pharmacogenetic testing report released to physician at 4 weeks post enrollment
Sponsors
Avera McKennan Hospital & University Health Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depression score | 24 weeks | response to medication following medication recommendation guided by pharmacogenetic testing |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical utility questionnaire | 24 weeks | This will be assessed through review of medical records and a study compliance questionnaire to be completed by the prescribing physician |
Countries
United States
Outcome results
None listed