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Melatonin Receptor Agonist
Ramelteon for Delirium (DREAM Trial)
Phase 4
Recruiting
Led By Jennifer Johnson, MD
Research Sponsored by Centennial Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Expected ICU length of stay and life expectancy at least 48 hours
Medical or surgical ICU patient
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 days
Awards & highlights
DREAM Trial Summary
This trial aims to find a treatment for delirium in ICU using a drug called ramelteon, which is used for insomnia.
Who is the study for?
This trial is for ICU patients who can take oral or tube medication within 48 hours of admission, expected to stay in the ICU and live at least another 48 hours. They must be able to consent. It's not for those with cirrhosis, alcohol withdrawal, certain drug use, ramelteon allergy, incarceration, pregnancy, acute brain conditions or non-English speakers.Check my eligibility
What is being tested?
The study tests if Ramelteon (an insomnia drug) can treat or prevent delirium by helping regulate sleep cycles in ICU patients. Participants will receive an 8mg dose of Ramelteon with the aim to see if it reduces instances of delirium.See study design
What are the potential side effects?
Ramelteon may cause dizziness, fatigue, headaches and hormonal changes like decreased testosterone levels and increased prolactin levels. Some people might experience allergic reactions.
DREAM Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am expected to stay in the ICU for at least 48 hours and live beyond that.
Select...
I am currently a patient in the ICU.
DREAM Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 14 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Days alive without delirium or coma in the ICU
Secondary outcome measures
Duration of delirium, defined as number of days CAM-ICU positive
ICU length of stay
Incidence of delirium, as defined by a positive CAM-ICU-7
+2 moreDREAM Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ramelteonExperimental Treatment1 Intervention
ramelteon 8 mg crushed tablet daily at 20:30
Group II: placeboPlacebo Group1 Intervention
placebo powder equivalent grams at 20:30
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ramelteon
FDA approved
Find a Location
Who is running the clinical trial?
Centennial Medical CenterLead Sponsor
Jennifer Johnson, MDPrincipal InvestigatorCentennial Medical Center
1 Previous Clinical Trials
93 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have reported being very sensitive or allergic to ramelteon.I was taking fluvoxamine before I was admitted.I can take medicine by mouth or through a tube within 2 days of ICU admission.I am expected to stay in the ICU for at least 48 hours and live beyond that.I have a current acute brain condition like an abscess, bleed, or meningitis.I am hearing-impaired and use sign language.People who have trouble seeing.I am currently a patient in the ICU.I or my legal representative can sign the consent form within 48 hours of being admitted to the ICU.You have been at a different hospital for more than 4 days before coming to this trial.I do not speak English.I have been diagnosed with cirrhosis.You are currently going through alcohol withdrawal.
Research Study Groups:
This trial has the following groups:- Group 1: ramelteon
- Group 2: placebo
Awards:
This trial has 4 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has ramelteon been given clearance by the FDA?
"As this is a phase 4 trial, confirming ramelteon's approval and safety profile, it received the highest possible score of 3."
Answered by AI
Is there precedent for utilizing ramelteon in medical research?
"Currently, there is one ongoing clinical trial exploring the potential of ramelteon. None of these experiments have entered Phase 3 yet. The majority of studies are conducted in Nashville, Tennessee with a single other location also participating in research for this drug."
Answered by AI
How many participants are receiving treatment as part of this research project?
"Affirmative. Clinicaltrials.gov attests to the active recruitment for this clinical trial, which was first posted on March 1st 2023 and last edited on March 22nd 2023. The researchers are seeking 506 participants from a single medical site."
Answered by AI
Are there any vacancies available in this clinical trial?
"Affirmative, clinicaltrials.gov attests that this scientific experiment is still in search of participants. This study was initially uploaded on the 1st of March 2023 and subsequently updated by 22nd March 2023 with a view to recruiting 506 volunteers at one research facility."
Answered by AI
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