Major Depressive Disorder
Conditions
Keywords
depression, pharmacogenetics, pharmacogenomics, major depressive disorder, genetics, anti-depressants
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
Mental illness affects one in four adults in the United States; approximately 61.5 million Americans experience mental illness in a given year. According to the National Alliance for the Mentally Ill, the impact of serious mental illness costs Americans $193.2 billion in lost earnings per year. In addition, mental illness patients have an increased risk of having chronic medical conditions, leading to increased costs and emergency service utilization for those conditions. In addition to substantial costs, patients with psychiatric illness are difficult to treat. More than two-thirds of patients with depression do not respond to first line therapy. Treatment often involves numerous trials of individual agents and combinations of medications in order to achieve optimal response. Pharmacogenetic testing is being used in more settings to guide treatment decisions.
Interventions
pharmacogenetic testing for anti-depressant/anti-psychotic medications
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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical outcomes (response to medication following medication recommendation guided by pharmacogenetic testing) | 24 weeks | response to medication following medication recommendation guided by pharmacogenetic testing |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical utility (Utilization by physicians in following medication recommendations guided by pharmacogenetic testing) | 24 weeks | Utilization by physicians in following medication recommendations guided by pharmacogenetic testing |
Countries
United States
Outcome results
None listed