Last updated on February 2018

Pharmacogenomic Decision Support With GeneSight Psychotropic to Guide the Treatment of Schizophrenia/Schizoaffective Disorder

Brief description of study

Evidence exists supporting the ability of genetic variations to influence patient drug response and side effects. To-date, no RCT has been conducted to evaluate the outcomes in schizophrenia/schizoaffective disorder patients following the use of pharmacogenomic guidance of treatment selections. The first objective of this trial is to utilize a double-blinded, randomized clinical trial design to evaluate the clinical outcomes in participants treated with the benefit of GeneSight Psychotropic (GEN) test. 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.

Detailed Study Description

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 patients suffering from schizophrenia/schizoaffective disorder; 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 schizophrenia/schizoaffective disorder. Participants will be randomized in a 1:1:1 ratio to each of the three treatment arms. Recruitment will be 27 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 the expected change in PANSS, with a difference between treatment groups (GEN and E-GEN) and TAU of 0.5 standard deviation. Assuming intra class coefficient between clusters of 20%, statistical power of 90%, an alpha level of 0.05, and an expected drop-out rate of 42% by Week 12, a total of 531 subjects (i.e., 177 per treatment arm) are required to detect the same effect in this study.

Clinical Study Identifier: NCT02573168

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