DeliriumPhase 2RECOVERNCT02324153
Ramelteon in the Prevention of Post-operative Delirium
A Phase 2 study testing Ramelteon, Microcrystalline Cellulose and Riboflavin 100 mg in people with Delirium and Delirium, Dementia, Amnestic, Cognitive Disorders, run by Johns Hopkins University at 1 site in United States.
Trial summary
This trial focuses on a Phase II randomized masked clinical trial testing the effectiveness and safety of peri-operative administration of ramelteon, a melatonin agonist in the prevention of postoperative delirium. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Delirium, Delirium, Dementia, Amnestic, Cognitive Disorders, Delayed Emergence From Anesthesia
- What is being tested?
- Ramelteon, Microcrystalline Cellulose and Riboflavin 100 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Mar 2017to 26 Jun 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
None listed.
Who cannot join
- Delirium diagnosis on the Confusion Assessment Method instrument at baseline
- Is unable to give informed consent due to cognitive impairment and a suitable legally authorized representative (LAR) cannot be identified
- Declines participation
- Current medications that include:
- ramelteon
- melatonin
Show all 15Show fewer
- fluvoxamine
- rifampin
- ketoconazole
- fluconazole
- History of ramelteon or riboflavin intolerance
- Heavy daily alcohol intake by medical record or history
- Current moderate to severe liver failure (as defined by Charlson criteria
- Evidence of Systemic Inflammatory Response Syndrome (SIRS) as measured by > 2 criteria8)
- Presence of a condition that in the opinion of the PI compromises patient safety or data quality if enrolled in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
About this study
Official title: A Randomized Double Blind Placebo Controlled Trial of Ramelteon in the Prevention of Post-operative Delirium in Older Patients Undergoing Orthopedic Surgery
This trial focuses on a Phase II randomized masked clinical trial testing the effectiveness and safety of peri-operative administration of ramelteon, a melatonin agonist in the prevention of postoperative delirium.
Read the detailed description
This trial will randomize older aged patients undergoing general or regional anesthesia for orthopedic surgical procedures to three perioperative doses of a melatonin agonist, ramelteon, and placebo in a masked double blind fashion. The primary outcomes are 1) the incidence of post-operative delirium in the recovery period in the Postoperative Anesthesia Care Unit and on post-operative days 1 and 2 following surgery, and 2) the safety of ramelteon as documented by the presence of adverse events in the follow-up period.
- Conditions
- Delirium, Delirium, Dementia, Amnestic, Cognitive Disorders, Delayed Emergence From Anesthesia, Cognitive Disorders
- Being tested
- Ramelteon, Microcrystalline Cellulose, Riboflavin 100 mg
- Keywords
- Post-operative Delirium
- Medical subject headings
- Delirium, Neurocognitive Disorders, Delayed Emergence from Anesthesia, Cognitive Dysfunction, Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RamelteonDrug
Also called Rozerem
1 pre-operative and 2 nightly postoperative doses of Ramelteon/placebo will be administered
Microcrystalline CelluloseDrug
Placebo Comparator
Riboflavin 100 mgDrug
Also called Adherence marker
Riboflavin will be added to both placebo and active intervention capsules in order to track adherence to dose while taken as an outpatient (i.e. only the first preoperative dose)
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Ramelteon 8 mg oral dose Riboflavin 100 mg (preoperative first dose only) Receives: Drug: Ramelteon; Drug: Microcrystalline Cellulose; Drug: Riboflavin 100 mg |
| Placebo | Placebo comparator | Capsule Shells filled with microcrystalline cellulose Riboflavin 100 mg (preoperative first dose only - if received as an outpatient) Receives: Drug: Microcrystalline Cellulose; Drug: Riboflavin 100 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Delirium During Two Days Following Surgery
Delirium DSM 5 based criteria informed by standardized history gathering, examination, cognitive evaluation using cognitive tests, informant interview, and medical record review) measured during Post-operative Day 1 and/or Day 2
Measured: Up to Post Operative Day 2
Number of Participants With Delirium in the Post Anesthesia Care Unit (PACU)
Delirium (DSM 5 based criteria informed by standardized history gathering, examination, cognitive evaluation using cognitive tests, informant interview, and medical record review) measured once recovered from anesthesia.
Measured: Post Operative Day 0: Post Anesthesia Care Unit Following Recovery from Anesthesia
Secondary outcomes (1)
Delirium Rating Scale - Revised- 98 (DRS-R98) in Delirious Patients
Measure Description: Delirium Rating Scale-Revised-98 (Severity items are rated on a scale of 0-3 and diagnostic items are rated on a scale of 0-2 or 0-3. The minimum score is 0. The maximum possible score for severity items is 39, while the maximum total score is 46. Higher scores indicate more severe delirium; score of 0 indicates no delirium.) Means and Standard Deviations were calculated from the maximum DRS-R98 score documented on Postoperative Day 1 and Day 2 for each participant who became delirious within each treatment arm.
Measured: Postoperative Day 1 and Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2014 (estimated)
- Study start24 Mar 2017
- Primary completion26 Jun 2019
- Study completion26 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Karin J Neufeld, MD MPH, Principal investigator, Professor - Department of Psychiatry and Behavioral Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02324153
- Sponsor's protocol ID
- IRB00097232
- Other IDs
- 1R21AG050850-01A1
- Acronym
- RECOVER
- Status last verified
- Jun 2020
- First submitted
- 15 Dec 2014
- Last updated
- 30 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Oh ES, Leoutsakos JM, Rosenberg PB, Pletnikova AM, Khanuja HS, Sterling RS, Oni JK, Sieber FE, Fedarko NS, Akhlaghi N, Neufeld KJ. Effects of Ramelteon on the Prevention of Postoperative Delirium in Older Patients Undergoing Orthopedic Surgery: The RECOVER Randomized Controlled Trial. Am J Geriatr Psychiatry. 2021 Jan;29(1):90-100. doi: 10.1016/j.jagp.2020.05.006. Epub 2020 May 16.
PubMed 32532654
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double Blind Placebo Controlled Trial of Ramelteon in the Prevention of Post-operative Delirium in Older Patients Undergoing Orthopedic Surgery
- ClinicalTrials.gov ID
- NCT02324153
- Acronym / sponsor ID
- RECOVER / IRB00097232
- Conditions
- Delirium, Delirium, Dementia, Amnestic, Cognitive Disorders, Delayed Emergence From Anesthesia, Cognitive Disorders
- Keywords
- Post-operative Delirium
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 24 Mar 2017 (actual)
- Primary completion
- 26 Jun 2019 (actual)
- Study completion
- 26 Jun 2019 (actual)
- First posted
- 24 Dec 2014 (estimated)
- Results
- Posted 30 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial focuses on a Phase II randomized masked clinical trial testing the effectiveness and safety of peri-operative administration of ramelteon, a melatonin agonist in the prevention of postoperative delirium.
Detailed description
This trial will randomize older aged patients undergoing general or regional anesthesia for orthopedic surgical procedures to three perioperative doses of a melatonin agonist, ramelteon, and placebo in a masked double blind fashion. The primary outcomes are 1) the incidence of post-operative delirium in the recovery period in the Postoperative Anesthesia Care Unit and on post-operative days 1 and 2 following surgery, and 2) the safety of ramelteon as documented by the presence of adverse events in the follow-up period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Ramelteon, Drug: Microcrystalline Cellulose, Drug: Riboflavin 100 mgRamelteon 8 mg oral dose Riboflavin 100 mg (preoperative first dose only) |
| Placebo | Placebo comparator | Drug: Microcrystalline Cellulose, Drug: Riboflavin 100 mgCapsule Shells filled with microcrystalline cellulose Riboflavin 100 mg (preoperative first dose only - if received as an outpatient) |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (15 listed)
- Delirium diagnosis on the Confusion Assessment Method instrument at baseline
- Is unable to give informed consent due to cognitive impairment and a suitable legally authorized representative (LAR) cannot be identified
- Declines participation
- Current medications that include:
- History of ramelteon or riboflavin intolerance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RamelteonAlso: Rozerem1 pre-operative and 2 nightly postoperative doses of Ramelteon/placebo will be administered | Drug | Treatment |
| Microcrystalline CellulosePlacebo Comparator | Drug | Placebo, Treatment |
| Riboflavin 100 mgAlso: Adherence markerRiboflavin will be added to both placebo and active intervention capsules in order to track adherence to dose while taken as an outpatient (i.e. only the first preoperative dose) | Drug | Placebo, Treatment |
Primary outcome
Number of Participants With Delirium During Two Days Following Surgery
Time frame: Up to Post Operative Day 2
Delirium DSM 5 based criteria informed by standardized history gathering, examination, cognitive evaluation using cognitive tests, informant interview, and medical record review) measured during Post-operative Day 1 and/or Day 2
Number of Participants With Delirium in the Post Anesthesia Care Unit (PACU)
Time frame: Post Operative Day 0: Post Anesthesia Care Unit Following Recovery from Anesthesia
Delirium (DSM 5 based criteria informed by standardized history gathering, examination, cognitive evaluation using cognitive tests, informant interview, and medical record review) measured once recovered from anesthesia.
1 secondary outcome
Delirium Rating Scale - Revised- 98 (DRS-R98) in Delirious Patients
Time frame: Postoperative Day 1 and Day 2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32532654Oh ES, Leoutsakos JM, Rosenberg PB, Pletnikova AM, Khanuja HS, Sterling RS, Oni JK, Sieber FE, Fedarko NS, Akhlaghi N, Neufeld KJ. Effects of Ramelteon on the Prevention of Postoperative Delirium in Older Patients Undergoing Orthopedic Surgery: The RECOVER Randomized Controlled Trial. Am J Geriatr Psychiatry. 2021 Jan;29(1):90-100. doi: 10.1016/j.jagp.2020.05.006. Epub 2020 May 16.
- Individual participant dataSharing planned: No
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Lactium Premedication to Prevent Emergence Agitation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karin J Neufeld, MD MPH principal investigator
Professor - Department of Psychiatry and Behavioral Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ramelteon, Microcrystalline Cellulose and Riboflavin 100 mg in people with Delirium and Delirium, Dementia, Amnestic, Cognitive Disorders, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Delirium During Two Days Following Surgery (time frame: Up to Post Operative Day 2). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02324153, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2020.