NCT00873379

Brief Summary

122 people over 70 who were admitted to hospital were enrolled to the study. Half got .5 mg a night of melatonin, half got a placebo.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2007

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 31, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 1, 2009

Completed
Last Updated

July 7, 2009

Status Verified

July 1, 2009

Enrollment Period

4 months

First QC Date

March 31, 2009

Last Update Submit

July 6, 2009

Conditions

Delirium

Outcome Measures

Primary Outcomes (1)

  • delirious using confusion assessment method (CAM)

    days

Secondary Outcomes (1)

  • MDAS (memorial delirium assessment scale)

    days

Study Arms (2)

melatonin

ACTIVE COMPARATOR

.5 mg (one half of a 1 mg tablet of GNC rapid dissolving Melatonin, natural product number (NPN) 80001380)

Dietary Supplement: melatonin

placebo

PLACEBO COMPARATOR

half a white placebo tablet

Dietary Supplement: placebo

Interventions

melatoninDIETARY_SUPPLEMENT

one half of a 1 mg tablet of GNC rapid dissolving Melatonin, NPN (natural product number) 80001380, available over the counter in Canada

melatonin
placeboDIETARY_SUPPLEMENT

half a white placebo tablet

placebo

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age over 65 admitted through the emergency department to an internal medicine service in London, Ontario, Canada.

You may not qualify if:

  • Life expectancy less than 24 hours,
  • Unable to communicate in English,
  • Unable to take oral medications,
  • Intracranial bleed or known seizure disorder,
  • Markedly sub or supra-therapeutic INR while on warfarin, OR
  • A known allergy to study tablet ingredients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

London Health Sciences Centre

London, Ontario, n6a5a5, Canada

Location

MeSH Terms

Conditions

Delirium

Interventions

Melatonin

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

TryptaminesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Chris Brymer, MD

    Western University, Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 31, 2009

First Posted

April 1, 2009

Study Start

October 1, 2007

Primary Completion

February 1, 2008

Study Completion

March 1, 2008

Last Updated

July 7, 2009

Record last verified: 2009-07

Locations

CA(1)