NCT00230737

Brief Summary

This study will determine whether melatonin tablets will increase the sleep of older adults with insomnia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2004

Typical duration for phase_2

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, 2004

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
21 days until next milestone

First Posted

Study publicly available on registry

October 3, 2005

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
8.9 years until next milestone

Results Posted

Study results publicly available

March 8, 2017

Completed
Last Updated

March 8, 2017

Status Verified

January 1, 2017

Enrollment Period

3.6 years

First QC Date

September 12, 2005

Results QC Date

January 17, 2017

Last Update Submit

January 17, 2017

Conditions

Sleep Initiation and Maintenance Disorders

Keywords

AgedSleepInsomniaMelatoninNeurobehavioral ManifestationsCircadian RhythmsHumanPolysomnographyElderly

Outcome Measures

Primary Outcomes (1)

  • Peak Melatonin Level

    Pharmacokinetic analysis of maximum melatonin level

    day 42

Study Arms (3)

A

EXPERIMENTAL

Melatonin 0.4 mg

Drug: Melatonin 0.4 mg

B

EXPERIMENTAL

Melatonin 4.0 mg

Drug: Melatonin 4.0 mg

C

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Melatonin 0.4 mgDRUG
A
Melatonin 4.0 mgDRUG
B
PlaceboDRUG
C

Eligibility Criteria

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

You may qualify if:

  • History of insomnia
  • Low melatonin levels at study entry

You may not qualify if:

  • History of sleep apnea (temporary cessation of breathing during sleep)
  • Diagnosis of restless legs syndrome
  • Current alcohol or substance abuse
  • Dementia
  • Anemia
  • Liver disease
  • Leukemia or lymphoma
  • Asthma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • Gooneratne NS, Edwards AY, Zhou C, Cuellar N, Grandner MA, Barrett JS. Melatonin pharmacokinetics following two different oral surge-sustained release doses in older adults. J Pineal Res. 2012 May;52(4):437-45. doi: 10.1111/j.1600-079X.2011.00958.x. Epub 2012 Feb 21.

    PMID: 22348451RESULT

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersNeurobehavioral Manifestations

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

Study did not meet total recruitment targets

Results Point of Contact

Title
Dr. Nalaka Gooneratne
Organization
University of Pennsylvania
ngoonera@upenn.edu
2674083789

Study Officials

  • Nalaka S. Gooneratne, MD,MSc

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 12, 2005

First Posted

October 3, 2005

Study Start

October 1, 2004

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

March 8, 2017

Results First Posted

March 8, 2017

Record last verified: 2017-01

Locations

US(1)