Ramelteon Prevention of Delirium - RCT

Randomized, Double Blind, Placebo-Controlled Clinical Trial Evaluating Ramelteon in the Prevention of Delirium

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.

Study Overview

• Status: Unknown
• Conditions: Delirium
• Intervention / Treatment: Drug: ramelteon; Drug: Placebo

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 Type: Interventional
• Enrollment (Anticipated): 240
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Robert S Dicks, MD; Phone Number: 860-545-7043; Email: robert.dicks@hhchealth.org
• Study Contact Backup: Name: christine waszynski, APRN; Phone Number: 860-545-7043; Email: christine.waszynski@hhchealth.org

Study Locations

• United States
  • Connecticut
    • Hartford, Connecticut, United States, 06102
      • Recruiting
      • Hartford Hospital
      • Contact: Robert S Dicks, MD; Phone Number: 860-545-7043; Email: robert.dicks@hhchealth.org
      • Contact: Christine Waszynski, DNP; Phone Number: 860-545-7043; Email: christine.waszynski@hhchealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• from designated nursing units

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
delirium	delirium as determined by CAM screening and expert review	through study completion, anticipate completion at 1 year

Collaborators and Investigators

• Sponsor: Hartford Hospital
• Investigators: Principal Investigator: Robert S Dicks, MD, Hartford Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2017
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): June 1, 2019

Study Registration Dates

• First Submitted: September 29, 2015
• First Submitted That Met QC Criteria: September 29, 2015
• First Posted (Estimate): October 1, 2015

Study Record Updates

• Last Update Posted (Actual): August 1, 2018
• Last Update Submitted That Met QC Criteria: July 31, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: prevention
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium
• Other Study ID Numbers: HHC-2015-0073

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No