Depression Clinical Trial
Official title:
A Three-arm, Parallel Group, Multicentre, Double-blind, Randomized Controlled Trial Evaluating the Impact of GeneSight Psychotropic and Enhanced-GeneSight Psychotropic, on Response to Psychotropic Treatment in Outpatients Suffering From a Major Depressive Disorder (MDD) and Having Had - Within the Current Episode - an Inadequate Response to at Least One Psychotropic Medication Included in GeneSight Psychotropic
Evidence exists supporting the ability of genetic variations to influence patient drug response and side effects. Previous studies utilizing an open-label design have shown significant improvement in major depressive disorder (MDD) patient outcomes following use of the GeneSight Psychotropic (GEN) test. The first objective of this trial is to utilize a double-blinded, randomized clinical trial design to replicate previous findings of improvement in clinical outcomes in MDD subjects whose medication therapy was guided by GEN testing. Another objective is to determine the added benefit of Enhanced-GeneSight (E-GEN) compared to GEN for the pharmacogenomic guidance of treatment selections. Furthermore, this trial intends to develop an evidence-based case for the value of GEN and E-GEN to Canadian healthcare payers.
The primary objectives of this study are 1) to compare the efficacy of GEN to treatment as
usual (TAU) in improving response to psychotropic treatment in outpatients suffering from a
MDD and having had - within the current episode - an inadequate response to at least one
psychotropic medication included in GEN; and 2) to validate the utility of the new CAMH
markers and demonstrate the superior predictive capabilities and greater clinical utility of
E-GEN as compared to GEN.
This study is designed as a three-arm multi-centre, double-blind (participants and raters),
randomized controlled trial to compare the clinical and economic outcomes of GEN, E-GEN and
TAU for patients suffering from a MDD and having had - within the current episode - an
inadequate response to at least one psychotropic medication included in GEN. Participants
will be randomized in a 1:1:1 ratio to each of the three treatment arms. Recruitment will be
24 months. Follow-up will be 12 months.
Subjects will complete short diagnostic interviews specific to their clinical diagnosis,
basic metabolic measures (eg. blood pressure, weight), and provide buccal swab samples for
genetic analysis (the unanalyzed buccal swabs and associated DNA will be biobanked). During
the first visit, blood and urine samples will be required for laboratory panel screening and
blood biobanking. Subjects will be monitored over a one year period and clinical measures and
healthcare resource utilization will be obtained. Treating clinicians in the GEN and E-GEN
arms will receive an easy to implement report providing pharmacogenomic guidance for
prescribing psychotropic medications to their patients.
The study will recruit subjects from 10 sites, stratified into 2 clusters. Nine study sites
altogether will form one of the two stratified clusters. CAMH will constitute the tenth study
site and the second stratified cluster.The sample size required for this study was calculated
using effect size estimates drawn from a previous study conducted by Hall-Flavin et al
[Pharmacogenetics Genomics 2013; 23(10)]. Assuming an effect size of 0.30 in HAM-D17 score
favoring the treatment group, intra class coefficient between clusters of 20%, statistical
power of 90%, an alpha level of 0.05, and an expected 16.7% rate of premature discontinuation
by Week 8 (primary endpoint), a total of 570 subjects (i.e., 190 per treatment arm) are
required to detect the same effect in this study.
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