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Pharmacogenetic Decision Support IT System for Psychiatric Hospitalization: RCT (CYP-GUIDES)

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ClinicalTrials.gov Identifier: NCT02120729
Recruitment Status : Active, not recruiting
First Posted : April 23, 2014
Last Update Posted : February 12, 2019
Sponsor:
Collaborator:
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
Hartford Hospital

Brief Summary:

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

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Length of Hospitalization Stay [ Time Frame: 30 days following discharge from index hospitalization ]
    Number of days hospitalized for the current psychiatric admission


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

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


Locations
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United States, Connecticut
Institute of Living at Hartford Hospital, Hartford Healthcare
Hartford, Connecticut, United States, 06114
Sponsors and Collaborators
Hartford Hospital
Agency for Healthcare Research and Quality (AHRQ)
Investigators
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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

Publications:
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Responsible Party: Hartford Hospital
ClinicalTrials.gov Identifier: NCT02120729     History of Changes
Other Study ID Numbers: RUAN004090HE
First Posted: April 23, 2014    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019

Keywords provided by Hartford Hospital:
Pharmacogenetics
CYP2D6 Mutations
Major Depressive Disorder
Psychiatric Inpatients
Length of Stay
30 Day Readmission Rate
Psychiatric hospital inpatients

Additional relevant MeSH terms:
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Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms