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.

Method: 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.

Trial registration: ClinicalTrials.gov identifier: NCT01507155.

Figures

Figure 1.

Consort Diagrama aThese data are generated from clinician and patient participants who were able to participate together or independently. Abbreviations: CGI-I = Clinical Global Impressions–Improvement scale, CGI-S = Clinical Global Impressions–Severity of Illness scale, DNA = deoxyribonucleic acid, QIDS-SR(16) = Quick Inventory of Depressive Symptoms, Q-LES-Q-SF = Quality of Life Enjoyment and Satisfaction Questionnaire–Short Form, SAS = Zung Self-Rated Anxiety Scale, UKU = Udvalg for Kliniske Undersøgelser Side Effect Rating Scale.

Figure 2.

Number of Previous Treatment Trialsa aData labels show percent of patients.

Figure 3.

CGI-I Distribution at 3 Monthsa aData labels show percent of patients. Abbreviation: CGI-I = Clinical Global Impressions–Improvement scale.

Figure 4.

Self-Reported Patient Scales