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Lack of resources to complete the study. Descriptive statistics for the outcome measures collected are provided.
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A double blind randomized controlled trial investigating melatonin, 5mg, compared to placebo, given to patients at least 65 years old, admitted to the hospital on a general medical floor, to prevent delirium.
This study will be a randomized double blind controlled trial, designed to evaluate the efficacy of melatonin in decreasing the incidence of delirium in elderly hospitalized adults compared to a placebo capsule. The study will be conducted on 4 general Internal Medicine inpatient floors at Yale-New Haven Hospital, St. Raphael's campus.
Within 24 hours of admission to the floor, study subjects will be approached by a member of the research team, and asked for informed consent. Patients that consent to participate will be randomized to either the treatment or the placebo arm. Each subject will be administered a capsule containing either placebo or 5 mg melatonin each evening at 9 p.m. The capsules will be prepared and administered by the Yale-New haven Hospital Investigational Drug Service. The capsules will be administered nightly until discharge or a maximum of 2 weeks, if the hospitalization is prolonged.
Subjects will be assessed twice daily by the floor nurses for evidence of delirium using the Short CAM (Confusion Assessment Method), which is a validated clinical tool for identifying delirium, and the current standard of practice tool for the diagnosis of delirium.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Melatonin | Experimental | 5 mg Melatonin nightly, beginning within 24 hours of admission |
|
| Cellulose Microcrystylline | Placebo Comparator | Blue capsule matching the melatonin arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Melatonin | Drug | 5 mg Melatonin nightly, beginning within 24 hours of admission |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Delirium | Delirium is defined by the Short Form Confusion Assessment Method (CAM). There must be inattention and either an acute or fluctuating course plus either disorganized thinking or an altered level of consciousness to be diagnosed with delirium. Presented is a count of individuals with reported delirium during hospitalization. | length of hospitalization, not to exceed 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Hospital Stay | Length of stay is defined as the total time hospitalized for the acute illness (in days). | from day of admission to completion of acute care, not to exceed 30 days |
| Days Utilizing Restraints |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen A Atlas, M.D. | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale New Haven Hospital, Saint Raphael Campus | New Haven | Connecticut | 06511 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16540616 | Background | Inouye SK. Delirium in older persons. N Engl J Med. 2006 Mar 16;354(11):1157-65. doi: 10.1056/NEJMra052321. No abstract available. | |
| 19069020 | Background | Miller MO. Evaluation and management of delirium in hospitalized older patients. Am Fam Physician. 2008 Dec 1;78(11):1265-70. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Melatonin | 5 mg Melatonin nightly, beginning within 24 hours of admission Melatonin |
| FG001 | Cellulose Microcrystylline | Blue capsule matching the melatonin arm Melatonin |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Melatonin | 5 mg Melatonin nightly, beginning within 24 hours of admission Melatonin |
| BG001 | Cellulose Microcrystylline | Blue capsule matching the melatonin arm Melatonin |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Delirium | Delirium is defined by the Short Form Confusion Assessment Method (CAM). There must be inattention and either an acute or fluctuating course plus either disorganized thinking or an altered level of consciousness to be diagnosed with delirium. Presented is a count of individuals with reported delirium during hospitalization. | Posted | Count of Participants | Participants | length of hospitalization, not to exceed 14 days |
|
Day of admission to completion of acute care, not to exceed 30 day
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Melatonin | 5 mg Melatonin nightly, beginning within 24 hours of admission Melatonin |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jesse S Reynolds | Yale Center for Analytical Sciences | (203) 785-5445 | jesse.reynolds@yale.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 30, 2017 | Jan 16, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003693 | Delirium |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D008550 | Melatonin |
| ID | Term |
|---|---|
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Placebo |
| Other |
Blue capsule matching the melatonin arm |
|
|
Days utilizing restraints is defined as the number of days restraints were applied because of delirium in the first 14 days of hospitalization.
| length of hospitalization, not to exceed 14 days |
| Number of Delirium Anti-psychotic Drug Doses Utilized for Delirium During the First 14 Days of Hospitalization. | Number of delirium anti-psychotic drug doses given for symptoms of delirium. Presented are the number of doses per days of hospitalization. | length of hospitalization, not to exceed 14 days |
| 21086534 | Background | de Jonghe A, Korevaar JC, van Munster BC, de Rooij SE. Effectiveness of melatonin treatment on circadian rhythm disturbances in dementia. Are there implications for delirium? A systematic review. Int J Geriatr Psychiatry. 2010 Dec;25(12):1201-8. doi: 10.1002/gps.2454. |
| 25183726 | Background | de Jonghe A, van Munster BC, Goslings JC, Kloen P, van Rees C, Wolvius R, van Velde R, Levi M, de Haan RJ, de Rooij SE; Amsterdam Delirium Study Group. Effect of melatonin on incidence of delirium among patients with hip fracture: a multicentre, double-blind randomized controlled trial. CMAJ. 2014 Oct 7;186(14):E547-56. doi: 10.1503/cmaj.140495. Epub 2014 Sep 2. |
| 21189854 | Background | Sultan SS. Assessment of role of perioperative melatonin in prevention and treatment of postoperative delirium after hip arthroplasty under spinal anesthesia in the elderly. Saudi J Anaesth. 2010 Sep;4(3):169-73. doi: 10.4103/1658-354X.71132. |
| 20845391 | Background | Al-Aama T, Brymer C, Gutmanis I, Woolmore-Goodwin SM, Esbaugh J, Dasgupta M. Melatonin decreases delirium in elderly patients: a randomized, placebo-controlled trial. Int J Geriatr Psychiatry. 2011 Jul;26(7):687-94. doi: 10.1002/gps.2582. Epub 2010 Sep 15. |
| 24554232 | Background | Hatta K, Kishi Y, Wada K, Takeuchi T, Odawara T, Usui C, Nakamura H; DELIRIA-J Group. Preventive effects of ramelteon on delirium: a randomized placebo-controlled trial. JAMA Psychiatry. 2014 Apr;71(4):397-403. doi: 10.1001/jamapsychiatry.2013.3320. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Length of Hospital Stay | Length of stay is defined as the total time hospitalized for the acute illness (in days). | Posted | Mean | Standard Deviation | days | from day of admission to completion of acute care, not to exceed 30 days |
|
|
|
| Secondary | Days Utilizing Restraints | Days utilizing restraints is defined as the number of days restraints were applied because of delirium in the first 14 days of hospitalization. | Posted | Median | Full Range | days | length of hospitalization, not to exceed 14 days |
|
|
|
| Secondary | Number of Delirium Anti-psychotic Drug Doses Utilized for Delirium During the First 14 Days of Hospitalization. | Number of delirium anti-psychotic drug doses given for symptoms of delirium. Presented are the number of doses per days of hospitalization. | Posted | Median | Full Range | number of doses per days of hospitalizat | length of hospitalization, not to exceed 14 days |
|
|
|
| 0 |
| 136 |
| 0 |
| 136 |
| 5 |
| 136 |
| EG001 | Cellulose Microcrystylline | Blue capsule matching the melatonin arm Melatonin | 0 | 141 | 0 | 141 | 1 | 141 |
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Lethargy | Nervous system disorders | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D006571 | Heterocyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |