Ramelteon Prevention of Delirium - RCT
Randomized, Double Blind, Placebo-Controlled Clinical Trial Evaluating Ramelteon in the Prevention of Delirium
1 other identifier
interventional
240
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Feb 2017
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 29, 2015
CompletedFirst Posted
Study publicly available on registry
October 1, 2015
CompletedStudy Start
First participant enrolled
February 23, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2019
CompletedAugust 1, 2018
July 1, 2018
1.8 years
September 29, 2015
July 31, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
delirium
delirium as determined by CAM screening and expert review
through study completion, anticipate completion at 1 year
Study Arms (2)
ramelteon
ACTIVE COMPARATORreceive ramelteon
placebo
PLACEBO COMPARATORreceive placebo
Interventions
Eligibility Criteria
You may qualify if:
- from designated nursing units
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hartford Hospital
Hartford, Connecticut, 06102, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert S Dicks, MD
Hartford Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director Geriatrics
Study Record Dates
First Submitted
September 29, 2015
First Posted
October 1, 2015
Study Start
February 23, 2017
Primary Completion
December 1, 2018
Study Completion
June 1, 2019
Last Updated
August 1, 2018
Record last verified: 2018-07