Trial Outcomes & Findings for Prevention of Delirium in Inpatients Utilizing Melatonin (NCT NCT02654314)
NCT ID: NCT02654314
Last Updated: 2022-03-21
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
277 participants
Primary outcome timeframe
length of hospitalization, not to exceed 14 days
Results posted on
2022-03-21
Participant Flow
Participant milestones
| Measure |
Melatonin
5 mg Melatonin nightly, beginning within 24 hours of admission
Melatonin
|
Cellulose Microcrystylline
Blue capsule matching the melatonin arm
Melatonin
|
|---|---|---|
|
Overall Study
STARTED
|
136
|
141
|
|
Overall Study
COMPLETED
|
136
|
141
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Prevention of Delirium in Inpatients Utilizing Melatonin
Baseline characteristics by cohort
| Measure |
Melatonin
n=136 Participants
5 mg Melatonin nightly, beginning within 24 hours of admission
Melatonin
|
Cellulose Microcrystylline
n=141 Participants
Blue capsule matching the melatonin arm
Melatonin
|
Total
n=277 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
77.98 years
STANDARD_DEVIATION 8.53 • n=5 Participants
|
78.99 years
STANDARD_DEVIATION 8.40 • n=7 Participants
|
78.49 years
STANDARD_DEVIATION 8.46 • n=5 Participants
|
|
Sex: Female, Male
Female
|
78 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
145 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
58 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
132 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
132 Participants
n=5 Participants
|
135 Participants
n=7 Participants
|
267 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
117 Participants
n=5 Participants
|
119 Participants
n=7 Participants
|
236 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
136 participants
n=5 Participants
|
141 participants
n=7 Participants
|
277 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: length of hospitalization, not to exceed 14 daysDelirium 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.
Outcome measures
| Measure |
Melatonin
n=136 Participants
5 mg Melatonin nightly, beginning within 24 hours of admission
Melatonin
|
Cellulose Microcrystylline
n=141 Participants
Blue capsule matching the melatonin arm
Melatonin
|
|---|---|---|
|
Delirium
|
2 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: from day of admission to completion of acute care, not to exceed 30 daysLength of stay is defined as the total time hospitalized for the acute illness (in days).
Outcome measures
| Measure |
Melatonin
n=136 Participants
5 mg Melatonin nightly, beginning within 24 hours of admission
Melatonin
|
Cellulose Microcrystylline
n=141 Participants
Blue capsule matching the melatonin arm
Melatonin
|
|---|---|---|
|
Length of Hospital Stay
|
4.58 days
Standard Deviation 2.91
|
4.71 days
Standard Deviation 3.70
|
SECONDARY outcome
Timeframe: length of hospitalization, not to exceed 14 daysDays utilizing restraints is defined as the number of days restraints were applied because of delirium in the first 14 days of hospitalization.
Outcome measures
| Measure |
Melatonin
n=136 Participants
5 mg Melatonin nightly, beginning within 24 hours of admission
Melatonin
|
Cellulose Microcrystylline
n=141 Participants
Blue capsule matching the melatonin arm
Melatonin
|
|---|---|---|
|
Days Utilizing Restraints
|
0 days
Interval 0.0 to 0.0
|
0 days
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: length of hospitalization, not to exceed 14 daysNumber of delirium anti-psychotic drug doses given for symptoms of delirium. Presented are the number of doses per days of hospitalization.
Outcome measures
| Measure |
Melatonin
n=136 Participants
5 mg Melatonin nightly, beginning within 24 hours of admission
Melatonin
|
Cellulose Microcrystylline
n=141 Participants
Blue capsule matching the melatonin arm
Melatonin
|
|---|---|---|
|
Number of Delirium Anti-psychotic Drug Doses Utilized for Delirium During the First 14 Days of Hospitalization.
|
0 number of doses per days of hospitalizat
Interval 0.0 to 1.0
|
0 number of doses per days of hospitalizat
Interval 0.0 to 1.0
|
Adverse Events
Melatonin
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Cellulose Microcrystylline
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Melatonin
n=136 participants at risk
5 mg Melatonin nightly, beginning within 24 hours of admission
Melatonin
|
Cellulose Microcrystylline
n=141 participants at risk
Blue capsule matching the melatonin arm
Melatonin
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
0.74%
1/136 • Number of events 1 • Day of admission to completion of acute care, not to exceed 30 day
|
0.00%
0/141 • Day of admission to completion of acute care, not to exceed 30 day
|
|
Gastrointestinal disorders
Vomiting
|
0.74%
1/136 • Number of events 1 • Day of admission to completion of acute care, not to exceed 30 day
|
0.00%
0/141 • Day of admission to completion of acute care, not to exceed 30 day
|
|
Gastrointestinal disorders
Constipation
|
0.74%
1/136 • Number of events 1 • Day of admission to completion of acute care, not to exceed 30 day
|
0.00%
0/141 • Day of admission to completion of acute care, not to exceed 30 day
|
|
Nervous system disorders
Somnolence
|
0.74%
1/136 • Number of events 1 • Day of admission to completion of acute care, not to exceed 30 day
|
0.00%
0/141 • Day of admission to completion of acute care, not to exceed 30 day
|
|
Nervous system disorders
Headache
|
0.74%
1/136 • Number of events 1 • Day of admission to completion of acute care, not to exceed 30 day
|
0.00%
0/141 • Day of admission to completion of acute care, not to exceed 30 day
|
|
Nervous system disorders
Lethargy
|
0.00%
0/136 • Day of admission to completion of acute care, not to exceed 30 day
|
0.71%
1/141 • Number of events 1 • Day of admission to completion of acute care, not to exceed 30 day
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.74%
1/136 • Number of events 1 • Day of admission to completion of acute care, not to exceed 30 day
|
0.00%
0/141 • Day of admission to completion of acute care, not to exceed 30 day
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.74%
1/136 • Number of events 1 • Day of admission to completion of acute care, not to exceed 30 day
|
0.00%
0/141 • Day of admission to completion of acute care, not to exceed 30 day
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place