Ramelteon Prevention of Delirium - RCT

Sponsor

Hartford Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02564939

Collaborator

(none)

240

Enrollment

Location

Arms

27.2

Anticipated Duration (Months)

8.8

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

Anticipated 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 :

Feb 23, 2017

Anticipated Primary Completion Date :

Dec 1, 2018

Anticipated Study Completion Date :

Jun 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: ramelteon receive ramelteon	Drug: ramelteon double-blind RCT Other Names: Rozerem
Placebo Comparator: placebo receive placebo	Drug: Placebo double-blind RCT

Arm

Intervention/Treatment

Active Comparator: ramelteon

receive ramelteon

Drug: ramelteon

double-blind RCT

Other Names:

Rozerem

Placebo Comparator: placebo

receive placebo

Drug: Placebo

double-blind RCT

Outcome Measures

Primary Outcome Measures

delirium [through study completion, anticipate completion at 1 year]
delirium as determined by CAM screening and expert review

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

from designated nursing units

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hartford Hospital	Hartford	Connecticut	United States	06102

Sponsors and Collaborators

Hartford Hospital

Investigators

Principal Investigator: Robert S Dicks, MD, Hartford Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Robert Dicks, Director Geriatrics, Hartford Hospital

ClinicalTrials.gov Identifier:

NCT02564939

Other Study ID Numbers:

HHC-2015-0073

First Posted:

Oct 1, 2015

Last Update Posted:

Aug 1, 2018

Last Verified:

Jul 1, 2018

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Robert Dicks, Director Geriatrics, Hartford Hospital

prevention

Additional relevant MeSH terms:

Delirium

Study Results

No Results Posted as of Aug 1, 2018