Recruiting

Ramelteon

Sponsor:

Hartford Hospital

Code:

NCT02564939

Conditions

Delirium

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

ramelteon

Placebo

Study Details

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.

Conditions

Delirium

Study ID

NCT02564939

Start date

Feb 23, 2017

Status verified date

Jul, 2018

Completion date

Jun, 2019

Anticipated

Primary completion date

Dec, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • from designated nursing units

Exclusion Criteria:

-

Study Design

Enrollment

240 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: ramelteon

receive ramelteon

placebo comparator: placebo

receive placebo

Interventions

ramelteon

double-blind RCT

Placebo

double-blind RCT

Primary outcome measure

  • delirium [ Time Frame: through study completion, anticipate completion at 1 year ]

Central Contacts and Locations

Central contacts

Robert S Dicks, MD

860-545-7043robert.dicks@hhchealth.org

christine waszynski, APRN

860-545-7043christine.waszynski@hhchealth.org

Locations

Hartford Hospital

Recruiting

Hartford, Connecticut, United States, 06102

Contacts

Robert S Dicks, MD

860-545-7043robert.dicks@hhchealth.org

Christine Waszynski, DNP

860-545-7043christine.waszynski@hhchealth.org

More Information

Sponsor

Hartford Hospital

Last update posted

Aug 1, 2018

Last verified

Jul, 2018

Keywords

  • prevention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hartford Hospital on 2018-08-01.