Clinical trial NCT02443584: Pharmacogenetic Testing on an Outpatient Population With a Depression Diagnosis
Official title: Pharmacogenetic Testing in an Outpatient Population of Patients With Major Depressive Disorder or Depressive Disorder Not Otherwise Specified With Avera Medical Group Clinics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Keywords: depression
pharmacogenetics
pharmacogenomics
major depressive disorder
genetics
anti-depressants
Lead sponsor: Avera McKennan Hospital & University Health Center
Sponsor class: OTHER
First posted: 2015-05-14
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical outcomes (response to medication following medication recommendation guided by pharmacogenetic testing)
timeFrame: 24 weeks
Secondary outcomes:
measure: Clinical utility (Utilization by physicians in following medication recommendations guided by pharmacogenetic testing)
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Sioux Falls
country: United States
facility: Avera McKennan Hospital & University Health Center
state: South Dakota
Study officials:
affiliation: Avera McKennan Hospital & University Health Center
name: Matthew Stanley, MD
role: PRINCIPAL_INVESTIGATOR
References: