Ramelteon in the Prevention of Post-operative Delirium

NCT02324153 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: IRB000972321R21AG050850-01A1
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Delirium; Delirium, Dementia, Amnestic, Cognitive Disorders; Delayed Emergence From Anesthesia; Cognitive Disorders

Keywords

Post-operative Delirium

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  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

  Postoperative Day 1 and Day 2

Study Arms (2)

Treatment

EXPERIMENTAL

Ramelteon 8 mg oral dose Riboflavin 100 mg (preoperative first dose only)

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)

Drug: Microcrystalline Cellulose; Drug: Riboflavin 100 mg

Interventions

Ramelteon DRUG

1 pre-operative and 2 nightly postoperative doses of Ramelteon/placebo will be administered

Also known as: Rozerem

Treatment

Microcrystalline Cellulose DRUG

Placebo Comparator

Placebo; Treatment

Riboflavin 100 mg DRUG

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)

Also known as: Adherence marker

Placebo; Treatment

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

Related Publications (1)

• 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.

  PMID: 32532654 DERIVED

MeSH Terms

Conditions

Delirium; Neurocognitive Disorders; Delayed Emergence from Anesthesia; Cognitive Dysfunction; Emergence Delirium

Interventions

ramelteon; microcrystalline cellulose; Riboflavin

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Postoperative Complications; Pathologic Processes; Cognition Disorders

Intervention Hierarchy (Ancestors)

Flavins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 3-Ring; Coenzymes; Enzymes and Coenzymes; Pigments, Biological; Biological Factors

Results Point of Contact

• Title: Karin Neufeld MD MPH: PI of Trial
• Organization: Johns Hopkins University School of Medicine

kneufel2@jhmi.edu

410-550-0197

Study Officials

• Karin J Neufeld, MD MPH

  Professor - Department of Psychiatry and Behavioral Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2014
• First Posted: December 24, 2014
• Study Start: March 24, 2017
• Primary Completion: June 26, 2019
• Study Completion: June 26, 2019
• Last Updated: June 30, 2020
• Results First Posted: June 30, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)