Trial · NCT02654314

Prevention of Delirium in Inpatients Utilizing Melatonin

NCT02654314, Phase 3, Terminated, Yale University; results first posted 2019-02-12

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Prevention of Delirium in Inpatients Utilizing Melatonin. Trials, record NCT02654314. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02654314

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Prevention of Delirium in Inpatients Utilizing Melatonin
NCT number: NCT02654314
Status: Terminated
Phases: Phase 3
Enrollment: 277 participants, actual
Lead sponsor: Yale University
Conditions: Delirium
Interventions: Melatonin, Placebo
First posted: 2016-01-13
Last updated: 2022-03-21
Results first posted: 2019-02-12

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Delirium	length of hospitalization, not to exceed 14 days	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.
Secondary	Length of Hospital Stay	from day of admission to completion of acute care, not to exceed 30 days	Length of stay is defined as the total time hospitalized for the acute illness (in days).
Secondary	Days Utilizing Restraints	length of hospitalization, not to exceed 14 days	Days utilizing restraints is defined as the number of days restraints were applied because of delirium in the first 14 days of hospitalization.
Secondary	Number of Delirium Anti-psychotic Drug Doses Utilized for Delirium During the First 14 Days of Hospitalization.	length of hospitalization, not to exceed 14 days	Number of delirium anti-psychotic drug doses given for symptoms of delirium. Presented are the number of doses per days of hospitalization.

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Delirium	length of hospitalization, not to exceed 14 days	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Length of Hospital Stay	from day of admission to completion of acute care, not to exceed 30 days	days	MEAN
SECONDARY	Days Utilizing Restraints	length of hospitalization, not to exceed 14 days	days	MEDIAN
SECONDARY	Number of Delirium Anti-psychotic Drug Doses Utilized for Delirium During the First 14 Days of Hospitalization.	length of hospitalization, not to exceed 14 days	number of doses per days of hospitalizat	MEDIAN

Source ClinicalTrials.gov

Results by group8

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Delirium	Melatonin	2		Participants
Delirium	Cellulose Microcrystylline	8		Participants
Length of Hospital Stay	Melatonin	4.58	Standard Deviation 2.91	days
Length of Hospital Stay	Cellulose Microcrystylline	4.71	Standard Deviation 3.70	days
Days Utilizing Restraints	Melatonin	0	Full Range 0 to 0	days
Days Utilizing Restraints	Cellulose Microcrystylline	0	Full Range 0 to 0	days
Number of Delirium Anti-psychotic Drug Doses Utilized for Delirium During the First 14 Days of Hospitalization.	Melatonin	0	Full Range 0 to 1	number of doses per days of hospitalizat
Number of Delirium Anti-psychotic Drug Doses Utilized for Delirium During the First 14 Days of Hospitalization.	Cellulose Microcrystylline	0	Full Range 0 to 1	number of doses per days of hospitalizat

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Melatonin	136
Overall Study	STARTED	Cellulose Microcrystylline	141
Overall Study	COMPLETED	Melatonin	136
Overall Study	COMPLETED	Cellulose Microcrystylline	141
Overall Study	NOT COMPLETED	Melatonin	0
Overall Study	NOT COMPLETED	Cellulose Microcrystylline	0

Source ClinicalTrials.gov

Adverse events16

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Abdominal Pain	Gastrointestinal disorders	Melatonin	1	136	1
other	Abdominal Pain	Gastrointestinal disorders	Cellulose Microcrystylline	0	141	0
other	Vomiting	Gastrointestinal disorders	Melatonin	1	136	1
other	Vomiting	Gastrointestinal disorders	Cellulose Microcrystylline	0	141	0
other	Constipation	Gastrointestinal disorders	Melatonin	1	136	1
other	Constipation	Gastrointestinal disorders	Cellulose Microcrystylline	0	141	0
other	Somnolence	Nervous system disorders	Melatonin	1	136	1
other	Somnolence	Nervous system disorders	Cellulose Microcrystylline	0	141	0
other	Headache	Nervous system disorders	Melatonin	1	136	1
other	Headache	Nervous system disorders	Cellulose Microcrystylline	0	141	0

1 to 10 of 16Source ClinicalTrials.gov

See all 16 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Melatonin	0	136
Total, all-cause mortality	Cellulose Microcrystylline	0	141
Total, other adverse events	Melatonin	5	136
Total, other adverse events	Cellulose Microcrystylline	1	141
Total, serious adverse events	Melatonin	0	136
Total, serious adverse events	Cellulose Microcrystylline	0	141

Source ClinicalTrials.gov

Papers7

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
16540616	BACKGROUND	PubMed
19069020	BACKGROUND	PubMed
20845391	BACKGROUND	PubMed
21086534	BACKGROUND	PubMed
21189854	BACKGROUND	PubMed
24554232	BACKGROUND	PubMed
25183726	BACKGROUND	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Melatonin vs Cellulose Microcrystylline: Delirium	Trial comparisons
Melatonin vs Cellulose Microcrystylline: deaths from any cause	Trial comparisons
Melatonin vs Cellulose Microcrystylline: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02654314

GET https://conductscience.org/api/trials/v1/NCT02654314/registered

API reference For AI assistants