Pharmacogenetic Decision Support IT System for Psychiatric Hospitalization: RCT (CYP-GUIDES)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02120729|
Recruitment Status : Active, not recruiting
First Posted : April 23, 2014
Last Update Posted : February 12, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder||Other: Genotype-guided care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1500 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Pharmacogenetic Decision Support IT System for Psychiatric Hospitalization: RCT|
|Actual Study Start Date :||March 2014|
|Actual Primary Completion Date :||August 2018|
|Estimated Study Completion Date :||October 2019|
No Intervention: Standard of Care
Patients assigned to standard-of-care pharmacotherapy, for whom CYP2D6 genotype is determined but not utilized to guide drug prescription and psychotropic therapy follows the institutional norm.
Active Comparator: Genotype-guided Care
Patients assigned to genetically-guided pharmacotherapy, for whom CYP2D6 genotype is determined but not utilized to guide drug prescription as part of psychotropic therapy.
Other: Genotype-guided care
Pharmacogenetic alerts are furnished to the clinician within 2 days of admission. Buccal cell DNA is analyzed for 21 common CYP2D6 polymorphisms and results quantified into a drug metabolism reserve index to establish levels of sub-normal function (poor metabolizer) or supra-normal function (rapid metabolizer). For the estimated 50% of patients who are poor or rapid metabolizers, CEMS will proscribe medications which are major CYP2D6 substrates.
- Length of Hospitalization Stay [ Time Frame: 30 days following discharge from index hospitalization ]Number of days hospitalized for the current psychiatric admission
- Readmission to Psychiatric Hospital within 30 days [ Time Frame: 30 days following discharge from index hospitalization ]Readmission to a hospital for psychiatric treatment within 30 days of discharge from index (current) hospitalization
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02120729
|United States, Connecticut|
|Institute of Living at Hartford Hospital, Hartford Healthcare|
|Hartford, Connecticut, United States, 06114|
|Principal Investigator:||Gualberto Ruano, M.D., Ph.D.||Hartford Hospital Genetics Research Center|
|Study Director:||John W Goethe, M.D. Retired||Institute of Living, Hartford Healthcare|