Clinical Trial Publications by AltheaDx

A Randomized Controlled Trial Driving Clinical Utility for the Treatment of Depression and Anxiety

Enhanced Therapeutic Efficacy

Patient Therapeutic Benefit for Depression Chart

Source: Bradley, et al.

Study Design Intro:

This 12-week study evaluated if pharmacogenetics can help guide therapeutic decisions for patients diagnosed with depression and/or anxiety disorders and improve patient outcomes by maximizing drug efficacy.

The trial design followed a prospective, randomized, subject- and rater-blinded approach enrolling 685 patients from clinical providers specializing in Psychiatry, Internal Medicine, Obstetrics & Gynecology, and Family Medicine. Study participants were randomized by disease and severity and allocated in 1:1 ratio to the experimental (PGx guided) or the control group (standard of care).

Patient assessments were determined using the HAM-D17 and HAM-A rating scales.


In patients diagnosed with depression, response rates (p= 0.001; OR: 4.72 [1.93-11.52]) and remission rates (p=0.02; OR: 3.54 [1.27-9.88]) were significantly higher in the pharmacogenetics-guided group as compared to the control group at 12 weeks. In addition, patients in the experimental group diagnosed with anxiety showed a meaningful improvement in HAM-A scores at both 8 and 12 weeks (p=0.02 and 0.02, respectively), along with higher response rates (p=0.04; OR: 1.76 [1.03-2.99]).

Cost-effectiveness of PGx Test to Guide Treatment for Major Depressive Disorder

A Markov state-transitions probability model was built to analyze the cost-effectiveness of IDgenetix® testing v. standard of care for MDD patients in general practice and psychiatric care settings. This analysis included moderate to severe MDD patients who were new to treatment and who were failing treatment.

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Estimating Cost Savings of Pharmacogenetic Testing for Depression in Real-World
Clinical Settings

This study utilizes published health care costs and clinical patient outcome data to model economic impact of pharmacogenetic-guided treatment for depression in a variety of clinical settings.

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Economic Evaluation of Implementing a Novel Pharmacogenomics Test (IDgenetix®) to Guide Treatment of Patients with Depression
and/or Anxiety

The purpose of this study was to estimate the cost effectiveness of IDgenetix-guided treatment choices in patients with depression and/or anxiety compared to patients treated with standard of care (SOC).

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CYP2D6 Copy Number Distribution in
the US Population

The cytochrome P450 superfamily of genes is well understood for their role in drug metabolism, with CYP2D6 being the most extensively studied. Although many CYP2D6 variants have been identified that contribute to variability in enzymatic function, the gene is also known to have stably inherited gene deletion and duplication events. In this report, we provide CYP2D6 copy number variation (CNV) data on the single most comprehensive US population data set reported to date.

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Please note: At this time, only clinicians can order IDgenetix directly. If you are a patient looking to try IDgenetix, please consult your local mental health provider.