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Ramelteon Prevention of Delirium - RCT

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ClinicalTrials.gov Identifier: NCT02564939
Recruitment Status : Unknown
Verified July 2018 by Robert Dicks, Hartford Hospital.
Recruitment status was:  Recruiting
First Posted : October 1, 2015
Last Update Posted : August 1, 2018
Sponsor:
Information provided by (Responsible Party):
Robert Dicks, Hartford Hospital

Brief Summary:
Delirium is a common morbid condition in hospitalized adults. Treatment of delirium has been unsatisfactory and prevention is the preferred goal. Based on limited experimental research, ramelteon appears to have promise for prevention. This study will evaluate ramelteon in prevention of delirium in a hospitalized adult population age 65+ in a double-blinded RCT.

Condition or disease Intervention/treatment Phase
Delirium Drug: ramelteon Drug: Placebo Phase 4

Detailed Description:

Delirium is a very common condition that is associated with significant complications in hospitalized adults.

The manifestations of delirium are the result of a disturbance of brain functioning, the causes of which include a very wide array of illnesses, intoxications, and stresses. Delirium has been estimated to affect 20-50% of hospitalized patients, and to be associated with longer hospital stay (2x), greater likelihood of discharge to nursing home (2x), and higher rate of death (2x). 20% have delirium on admission. Patients who experience delirium may have persistent confusion (cognitive impairment). In 20%, this confusion appears to be permanent. Treatment of delirium has been unsatisfactory. Once it develops, no therapy or intervention has demonstrated a meaningful reduction of delirium associated complications. Prevention is clearly the preferred goal. Based on limited reports, ramelteon appears to have the most promise for prevention. Ramelteon, FDA approved (2005) as a nonscheduled prescription hypnotic agent, is generally considered safe and effective with no serious associated side effects, and no limitation of duration of use. It is related to melatonin in action and shares sleep promoting effects (reduced sleep latency) and improvement in coordination of circadian cycles. A recent randomized placebo-controlled single blinded trial of ramelteon treated 33 patients with ramelteon 8 mg/d. The researchers reported that ramelteon was associated with a dramatically lower risk of delirium (3% vs 32%; P = .003), with a relative risk of 0.09. Estimates of time to develop delirium were delayed for ramelteon compared to placebo, and the frequency of delirium was significantly lower in ramelteon compared to placebo (P = .002). There were significant limitations of this study, however, including a very high exclusion rate (1059 of 1126 [94%] patients assessed were excluded), a 24+ hour delay in initiation of study agent, a small sample size, and unclear sampling bias. The investigators propose a clinical trial of ramelteon to prevent delirium in patients admitted to Hartford Hospital. Hartford Hospital is in a unique position to conduct this study having established the ADAPT program to systematically apply best practices to the assessment and management of delirium. A registry of patients screened contains all of the screening results (over 1.5 million CAM screens on nearly 91,000 patients). Our study will permit us to evaluate the recent limited research findings regarding ramelteon in a larger general adult hospitalized population, and evaluate the potential benefit of treatment started earlier in the course of a hospitalization.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Randomized, Double Blind, Placebo-Controlled Clinical Trial Evaluating Ramelteon in the Prevention of Delirium
Actual Study Start Date : February 23, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium
Drug Information available for: Ramelteon

Arm Intervention/treatment
Active Comparator: ramelteon
receive ramelteon
Drug: ramelteon
double-blind RCT
Other Name: Rozerem

Placebo Comparator: placebo
receive placebo
Drug: Placebo
double-blind RCT




Primary Outcome Measures :
  1. delirium [ Time Frame: through study completion, anticipate completion at 1 year ]
    delirium as determined by CAM screening and expert review



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • from designated nursing units

Exclusion Criteria:

-


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): NCT02564939


Contacts
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Contact: Robert S Dicks, MD 860-545-7043 robert.dicks@hhchealth.org
Contact: christine waszynski, APRN 860-545-7043 christine.waszynski@hhchealth.org

Locations
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United States, Connecticut
Hartford Hospital Recruiting
Hartford, Connecticut, United States, 06102
Contact: Robert S Dicks, MD    860-545-7043    robert.dicks@hhchealth.org   
Contact: Christine Waszynski, DNP    860-545-7043    christine.waszynski@hhchealth.org   
Sponsors and Collaborators
Hartford Hospital
Investigators
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Principal Investigator: Robert S Dicks, MD Hartford Hospital
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Responsible Party: Robert Dicks, Director Geriatrics, Hartford Hospital
ClinicalTrials.gov Identifier: NCT02564939    
Other Study ID Numbers: HHC-2015-0073
First Posted: October 1, 2015    Key Record Dates
Last Update Posted: August 1, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Robert Dicks, Hartford Hospital:
prevention
Additional relevant MeSH terms:
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Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders