Pharmacogenetic Decision Support IT System for Psychiatric Hospitalization: RCT

Status unconfirmed · Not applicable

Conditions studied: Major Depressive Disorder

In brief

This Randomized Clinical Trial (RCT) compares outcomes in patients with major depressive disorder (MDD) treated according to the patient's CYP2D6 genotype status versus empiric "standard-of-care" psychotropic therapy. The hypothesis is that provision of medication based on the functional status of the patient's CYP2D6 enzyme inferred from genotype results within 48 hours of admission to treating clinicians will, through refined selection of psychotropic medication during hospitalization, decrease length of psychiatric hospitalization stay and decrease the rate of 30 day re-admission. The trial setting is the Hartford Hospital Institute of Living (IOL). The IOL operated the Clinical Evaluation and Monitoring System (CEMS), an innovative electronic messaging system developed by Co-Investigator Dr. J.W. Goethe. The Hartford Hospital Genetics Research Center (GRC) performs the genotype testing. CYP2D6 genotype analysis detects all known polymorphisms that result in an enzyme with sub-normal or supra-normal function. In this study, CEMS transmits clinically actionable guidance based on the patient's genotype to the clinician, advancing the medication alerts in real time. The RCT will test the effects of timely incorporation of medication recommendations based on CYP2D6 genotype into CEMS. The RCT randomizes patients to standard therapy (Group S) for whom CYP2D6 genetic information is determined but not transmitted to the treating clinician, allowing psychotropic therapy to be empirically determined, and to genetically guided therapy (Group G) where genotyping result and treatment recommendations are furnished via CEMS to the clinician within 48 hours of admission. For patients in Group G who are poor or rapid metabolizers, medications primarily metabolized by the CYP2D6 enzyme are proscribed. The primary outcome is hospital length of stay and the secondary outcome, the frequency of 30 day hospital readmission. Additional genetic stratification of both Group S and Group G will allow investigation of specific psychotropic usage. The expected benefits are (1) quantitative understanding of the effect of providing CYP2D6 pharmacogenetic information on length of hospitalization, 30 day readmission rate, and associated costs; and (2) objective benchmarking for the comparative effectiveness of CYP2D6 genotyping for guiding psychotropic therapy.

Key facts

Study ID

NCT02120729

Run by

Hartford Hospital

People needed

1500

Starts

2014-03-01

Expected to finish

2019-10-01

Last updated by the study team

2019-02-12

Who can join

Age: 18 and older, up to 95. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men or women aged 18 y or older.
• Patients who have been admitted to the Institute of Living and having a diagnosis of major depressive disorder.
• The ability to understand the requirements of the study.
• The ability to comply with study procedures and protocol.
• A woman is eligible to enter the study if she is of child-bearing potential and not pregnant or nursing.

You may not qualify if…

• Children and adolescents
• Hospital admission within previous 30 d of current admission.
• History of dementia or Alzheimer's disease
• History of chronic kidney disease (CKD).
• Surgery within 6 wk.
• Ischemic stroke within 6 wk.
• Any history of hemorrhagic stroke or subarachnoid hemorrhage.
• Current enrollment in an investigational drug or device study that has not reached the time of the primary end point

Where it is running

• Institute of Living at Hartford Hospital, Hartford Healthcare — Hartford, Connecticut, United States

Full record on ClinicalTrials.gov

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