Ramelteon vs Placebo for Prevention of Delirium and Improvement of Sleep in Hospitalized Older Adults

NCT03165695 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: 2017P000656
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates whether Ramelteon can prevent delirium, decrease the severity of incident delirium and improve sleep wake cycle in hospitalized elderly surgical patients. Half of the patients will be assigned to Ramelteon, while other half will be assigned to placebo.

Conditions

Delirium in Old Age

Keywords

Delirium; Insomnia; Ramelteon

Outcome Measures

Primary Outcomes (1)

• Incidence of delirium

  Incidence of delirium measured by DRS-98R

  7 days or less depending on the length of hospital stay

Secondary Outcomes (2)

• Severity of delirium

  7 days or less depending on the length of hospital stay

• Sleep improvement

  7 days or less depending on the length of hospital stay

Study Arms (2)

Ramelteon Arm

EXPERIMENTAL

Ramelteon tablet 8 mg orally at 21:00 for 7 days or until discharge whichever comes first.

Drug: Ramelteon

Placebo Arm

PLACEBO COMPARATOR

Sugar pill manufactured to mimic Ramelteon 8 mg tablet orally at 21:00 for 7 days or until discharge whichever comes first.

Drug: Placebo

Interventions

Ramelteon DRUG

Ramelteon 8 mg tablet orally at 21:00 for 7 days or until discharge whichever comes first

Also known as: Rozerem

Ramelteon Arm

Placebo DRUG

Placebo, 1 tablet orally at 21:00 or until discharge whichever comes first

Placebo Arm

Eligibility Criteria

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

You may qualify if:

• years of age or older.
• Admitted to BWH vascular surgical service.
• Able to provide informed consent or a surrogate is available to provide informed consent.
• Absence of delirium at time of consent.

You may not qualify if:

• Expected stay or life expectancy less than 48 hours
• Unable to take medications orally
• Advanced liver disease (Child-Pugh class B or worse)
• Active treatment with Fluvoxamine
• Active treatment with antipsychotic medications, benzodiazepines or other hypnotic agents (i.e. Trazodone, Mirtazapine, Zolpidem, Zaleplon)
• Known or suspected diagnosis of Lewy body dementia
• Any dermatological condition that may be aggravated by using a wrist sensor.
• Known pre-existing sleep disorder other than insomnia.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Delirium; Sleep Initiation and Maintenance Disorders

Interventions

ramelteon

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders

Study Officials

• Elizabeth B Klerman, M.D.,PhD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine, Harvard Medical School

Study Record Dates

• First Submitted: May 22, 2017
• First Posted: May 24, 2017
• Study Start: December 1, 2019
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: January 22, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)