title: A Naturalistic Study of the Effectiveness of Pharmacogenetic Testing to Guide Treatment in Psychiatric Patients With Mood and Anxiety Disorders.
abstract: OBJECTIVE
  To examine the effectiveness of genetic testing in a real-world setting and to assess its impact on clinician treatment decisions.
  
  
  METHODS
  This was a naturalistic, unblinded, prospective analysis of psychiatric patients and clinicians who utilized a commercially available genetic test (between April and October of 2013), which incorporates 10 genes related to pharmacokinetics and pharmacodynamics of psychiatric medications. Each patient's genetic results were provided to participating clinicians, who completed a baseline survey including patient medications, history, and severity of illness. Clinicians were prompted to complete surveys within 1 week of receiving the genetic results and again 3 months later. Patients likewise completed assessments of depression, anxiety, medication side effects, and quality of life at baseline, 1 month, and 3 months.
  
  
  RESULTS
  Data from 685 patients were collected. Approximately 70% and 29% of patients had primary diagnoses of either a mood or anxiety disorder, respectively. Clinician-reported data, as measured by the Clinical Global Impressions-Improvement scale, indicated that 87% of patients showed clinically measurable improvement (rated as very much improved, much improved, or minimally improved), with 62% demonstrating clinically significant improvement. When analysis was restricted to the 69% of individuals with ≥ 2 prior treatment failures, 91% showed clinically measurable improvement. Patients also reported significant decreases in depression (P < .001), anxiety (P < .001), and medication side effects (P < .001) and increases in quality of life (P < .001).
  
  
  CONCLUSIONS
  These results suggest that a substantial proportion of individuals receiving pharmacogenetic testing showed clinically significant improvements on multiple measures of symptoms, adverse effects, and quality of life over 3 months. In the absence of a treatment-as-usual comparator, the proportion of improvement attributable to the test cannot be estimated.
  
  
  BACKGROUND
  ClinicalTrials.gov identifier: NCT01507155.
authors.affiliation: Genomind, Inc, King of Prussia, Pennsylvania (Drs Brennan, Lombard, and Scott and Ms Gardner); Department of Psychiatry, Massachusetts General Hospital, Boston (Drs Perlis and Fava); and North Carolina Elderly Psychiatric Services, Raleigh (Dr Harris).
authors.forename: Francis X
authors.initials: FX
authors.lastname: Brennan
authors.affiliation: Genomind, Inc, King of Prussia, Pennsylvania (Drs Brennan, Lombard, and Scott and Ms Gardner); Department of Psychiatry, Massachusetts General Hospital, Boston (Drs Perlis and Fava); and North Carolina Elderly Psychiatric Services, Raleigh (Dr Harris).
authors.forename: Kathryn R
authors.initials: KR
authors.lastname: Gardner
authors.affiliation: Genomind, Inc, King of Prussia, Pennsylvania (Drs Brennan, Lombard, and Scott and Ms Gardner); Department of Psychiatry, Massachusetts General Hospital, Boston (Drs Perlis and Fava); and North Carolina Elderly Psychiatric Services, Raleigh (Dr Harris).
authors.forename: Jay
authors.initials: J
authors.lastname: Lombard
authors.affiliation: Genomind, Inc, King of Prussia, Pennsylvania (Drs Brennan, Lombard, and Scott and Ms Gardner); Department of Psychiatry, Massachusetts General Hospital, Boston (Drs Perlis and Fava); and North Carolina Elderly Psychiatric Services, Raleigh (Dr Harris).
authors.forename: Roy H
authors.initials: RH
authors.lastname: Perlis
authors.affiliation: Genomind, Inc, King of Prussia, Pennsylvania (Drs Brennan, Lombard, and Scott and Ms Gardner); Department of Psychiatry, Massachusetts General Hospital, Boston (Drs Perlis and Fava); and North Carolina Elderly Psychiatric Services, Raleigh (Dr Harris).
authors.forename: Maurizio
authors.initials: M
authors.lastname: Fava
authors.affiliation: Genomind, Inc, King of Prussia, Pennsylvania (Drs Brennan, Lombard, and Scott and Ms Gardner); Department of Psychiatry, Massachusetts General Hospital, Boston (Drs Perlis and Fava); and North Carolina Elderly Psychiatric Services, Raleigh (Dr Harris).
authors.forename: Herbert W
authors.initials: HW
authors.lastname: Harris
authors.affiliation: Genomind, Inc, King of Prussia, Pennsylvania (Drs Brennan, Lombard, and Scott and Ms Gardner); Department of Psychiatry, Massachusetts General Hospital, Boston (Drs Perlis and Fava); and North Carolina Elderly Psychiatric Services, Raleigh (Dr Harris).
authors.forename: Rachel
authors.initials: R
authors.lastname: Scott