“Pharmacogenomic Decision Support With GeneSight Psychotropic to Guide the Treatment of Schizophrenia/Schizoaffective Disorder”
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.
Genetic - GeneSight Psychotropic (GEN)
Patient DNA will be collected for all subjects and measured for variations in drug target genes and in drug metabolizing genes.Recommendations for optimal choices and dose adjustments for the 33 most commonly prescribed antidepressant and antipsychotic medications will be provided to subjects randomized to the GEN arm. This pharmacogenomic-based interpretive report will be provided to treating clinicians of patients in the GEN arm of the study, allowing clinicians to use the report to support th ...read more on ClinicalTrials.org
Genetic - Enhanced-GeneSight Psychotropic (E-GEN)
The E-GEN test incorporates into the existing GEN product new markers that are predictive of side effect of antipsychotic-induced weight gain (AIWG). The pharmacogenomic-based interpretive report from E-GEN will be provided to treating clinicians of patients in the E-GEN arm of the study, allowing clinicians to use the report to support their treatment decisions.
Treatment as Usual (TAU)
Subjects randomized to the TAU arm will also require collection of patient DNA. A pharmacogenomic-based interpretive report will be generated from GEN, however, this report is not provided to the treating clinician until completion of the study.
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 Patients Suffering From Schizophrenia/Schizoaffective Disorder