BlindnessNCT00692094

Blind Elderly Melatonin Treatment Study

A study testing Melatonin in people with Blindness, run by Oregon Health and Science University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The primary focus of this five-year study will be to optimize the melatonin dosing regimen for synchronizing the body clocks of elderly blind individuals to the 24-hour day. Read more about this study

Who is it for?: Ages 55 years and older
Conditions the study is for: Blindness
What is being tested?: Melatonin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteUnited States
Study dates: Aug 2004to Dec 2008
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 55 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Adults 55-100 years old
Blindness for at least one year, verified by an ophthalmologic exam
Ability to comply with the requirements of the experimental protocol
No clinically significant abnormalities (other than blindness) on a general physical examination
Subjects must be competent to sign informed consent

Who cannot join

Abnormal heart, liver or kidney function; a current Axis I psychiatric or substance abuse disorder according to the DSM-IV Manual
A diagnosis of obstructive sleep apnea (apnea index > 10) or nocturnal myoclonus (> 10 associated arousals/hour)
External demands that limit the ability to maintain a regular schedule, e.g., night shift work

Trial locations and contacts

1 site in 1 country.

United States1 site

Sleep and Mood Disorders Lab, Oregon Health & Science University
Portland, Oregon, 97239

Other trials in United States

About this study

Official title: Melatonin Entrainment of Elderly Blind Free-runners

The primary focus of this five-year study will be to optimize the melatonin dosing regimen for synchronizing the body clocks of elderly blind individuals to the 24-hour day.

Read the detailed description

The investigators intend to study as many as 26 subjects through up to four melatonin treatment regimens, all of which involve a dose step-down in which the melatonin dose will be reduced gradually to find the lowest effective dose. The 4 treatment plans differ only in the start dose and the time of administration. Successfully treated subjects will enter a one-year intensive assessment of the safety and efficacy of melatonin treatment in which the subject will take the same dose for one year and complete biweekly assessments of efficacy and side-effects. The final phase of the study involves a placebo discontinuation, in which the subject's circadian rhythm will be returned to the baseline rhythm (this may take up to 6 months for some subjects).

Conditions: Blindness
Being tested: Melatonin
Keywords: melatonin, circadian rhythms, sleep
Medical subject headings: Blindness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MelatoninBiological
0.025 mg-0.5 mg, daily given at a time when it is expected to delay the timing of the body clock.
MelatoninBiological
0.025 mg - 0.5 mg, daily, at a time when melatonin should advance the timing of their body clock.
MelatoninBiological
0.025 mg - 10 mg, daily, at a time when melatonin should advance the timing of their body clock.
MelatoninBiological
0.025 mg - 20 mg, daily, at a time when the melatonin should advance the timing of the body clock.

Study groups in NCT00692094
Study group	Role	What they receive
1	Experimental	Subjects will be given 0.5 mg at a time when melatonin should delay the timing of their body clock. If the subject's body clock responds successfully to the dose, the dose will be reduced gradually until the lowest effective dose is found. If the treatment does not work, the subject will be taken off treatment and later entered into a new treatment regimen. Receives: Biological: Melatonin
2	Experimental	Subjects will be given 0.5 mg at a time when melatonin should advance the timing of their body clock. If the subject's body clock responds successfully to the dose, the dose will be reduced gradually until the lowest effective dose is found. If the treatment does not work, the subject will be taken off treatment and later entered into a new treatment regimen. Receives: Biological: Melatonin
3	Experimental	Subjects will be given a larger dose (up to 10 mg) at a time when the melatonin should advance the timing of the body clock. If the subject's body clock responds successfully to the dose, the dose will be reduced gradually until the lowest effective dose is found. If the treatment does not work, the subject will be taken off treatment and later entered into a new treatment regimen. Receives: Biological: Melatonin
4	Experimental	Subjects will be given a larger dose (up to 20 mg) at a time when the melatonin should advance the timing of the body clock. If the subject successfully responds to the treatment, the dose will be reduced gradually until the lowest effective dose is determined (down to 0.025 mg). If the treatment does not work, the subject will be taken off treatment and later entered into a new treatment regimen. Receives: Biological: Melatonin

What is being measured

The primary outcome is the main question the study is designed to answer.

Circadian Phase Marker, as Measured by the Melatonin Levels in Serial Salivary and/or Plasma Samples.
Measured: biweekly throughout the entire study

Secondary outcomes (1)

Durability and Toxicity Side Effects Questionnaire
Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2004Dec 2008

First posted6 Jun 2008 (estimated)
Study startAug 2004
Primary completionMay 2008
Study completionDec 2008

Why it stopped: Unique provision in the American Recovery and Reinvestment Act prevented approval of second year no-cost-extension in which completion of analyses were planned.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for BlindnessStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00692094
Sponsor's protocol ID: eIRB 0194
Other IDs: R01AG021826
Status last verified: Nov 2019
First submitted: 30 May 2008
Last updated: 27 Nov 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Lewy AJ. Melatonin as a marker and phase-resetter of circadian rhythms in humans. Adv Exp Med Biol. 1999;460:425-34. doi: 10.1007/0-306-46814-x_51. No abstract available.
PubMed 10810544
Sack RL, Brandes RW, Kendall AR, Lewy AJ. Entrainment of free-running circadian rhythms by melatonin in blind people. N Engl J Med. 2000 Oct 12;343(15):1070-7. doi: 10.1056/NEJM200010123431503.
PubMed 11027741
Lewy AJ, Bauer VK, Hasler BP, Kendall AR, Pires ML, Sack RL. Capturing the circadian rhythms of free-running blind people with 0.5 mg melatonin. Brain Res. 2001 Nov 9;918(1-2):96-100. doi: 10.1016/s0006-8993(01)02964-x.
PubMed 11684046
Lewy AJ, Emens JS, Lefler BJ, Yuhas K, Jackman AR. Melatonin entrains free-running blind people according to a physiological dose-response curve. Chronobiol Int. 2005;22(6):1093-106. doi: 10.1080/07420520500398064.
PubMed 16393710

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Blindness trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Melatonin Entrainment of Elderly Blind Free-runners
ClinicalTrials.gov ID: NCT00692094
Acronym / sponsor ID: eIRB 0194
Conditions: Blindness
Keywords: melatonin, circadian rhythms, sleep
Study type: Interventional
Recruitment status: TerminatedReason stopped: Unique provision in the American Recovery and Reinvestment Act prevented approval of second year no-cost-extension in which completion of analyses were planned.
Enrolment: 12 participants (actual)
Lead sponsor: Oregon Health and Science UniversityUniversity, hospital or other
Collaborators: National Institute on Aging (NIA)
Study start: Aug 2004
Primary completion: May 2008 (actual)
Study completion: Dec 2008 (actual)
First posted: 6 Jun 2008 (estimated)
Results: Posted 27 Nov 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The primary focus of this five-year study will be to optimize the melatonin dosing regimen for synchronizing the body clocks of elderly blind individuals to the 24-hour day.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 4

Arm	Type	Receives
1	Experimental	Biological: MelatoninSubjects will be given 0.5 mg at a time when melatonin should delay the timing of their body clock. If the subject's body clock responds successfully to the dose, the dose will be reduced gradually until the lowest effective dose is found. If the treatment does not work, the subject will be taken off treatment and later entered into a new treatment regimen.
2	Experimental	Biological: MelatoninSubjects will be given 0.5 mg at a time when melatonin should advance the timing of their body clock. If the subject's body clock responds successfully to the dose, the dose will be reduced gradually until the lowest effective dose is found. If the treatment does not work, the subject will be taken off treatment and later entered into a new treatment regimen.
3	Experimental	Biological: MelatoninSubjects will be given a larger dose (up to 10 mg) at a time when the melatonin should advance the timing of the body clock. If the subject's body clock responds successfully to the dose, the dose will be reduced gradually until the lowest effective dose is found. If the treatment does not work, the subject will be taken off treatment and later entered into a new treatment regimen.
4	Experimental	Biological: MelatoninSubjects will be given a larger dose (up to 20 mg) at a time when the melatonin should advance the timing of the body clock. If the subject successfully responds to the treatment, the dose will be reduced gradually until the lowest effective dose is determined (down to 0.025 mg). If the treatment does not work, the subject will be taken off treatment and later entered into a new treatment regimen.

Who may qualify

Ages: 55 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Adults 55-100 years old
Blindness for at least one year, verified by an ophthalmologic exam
Ability to comply with the requirements of the experimental protocol
No clinically significant abnormalities (other than blindness) on a general physical examination
Subjects must be competent to sign informed consent

Key exclusion criteria (3 listed)

Abnormal heart, liver or kidney function; a current Axis I psychiatric or substance abuse disorder according to the DSM-IV Manual
A diagnosis of obstructive sleep apnea (apnea index > 10) or nocturnal myoclonus (> 10 associated arousals/hour)
External demands that limit the ability to maintain a regular schedule, e.g., night shift work

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Melatonin0.025 mg-0.5 mg, daily given at a time when it is expected to delay the timing of the body clock.	Biological	1
Melatonin0.025 mg - 0.5 mg, daily, at a time when melatonin should advance the timing of their body clock.	Biological	2
Melatonin0.025 mg - 10 mg, daily, at a time when melatonin should advance the timing of their body clock.	Biological	3
Melatonin0.025 mg - 20 mg, daily, at a time when the melatonin should advance the timing of the body clock.	Biological	4

Primary outcome

Circadian Phase Marker, as Measured by the Melatonin Levels in Serial Salivary and/or Plasma Samples.
Time frame: biweekly throughout the entire study

1 secondary outcome

Durability and Toxicity Side Effects Questionnaire
Time frame: 1 year

Results and safety

Results posted to the registry on 27 Nov 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Melatonin: 0.025 Mg-0.5 mg (Delay Timing)	0	0
Melatonin: 0.025 mg - 0.5 mg (Advance Timing)	0	0
Melatonin: 0.025 mg - 10 mg (Advance Timing)	0	0
Melatonin: 0.025 mg - 20 mg (Advance Timing)	0	0

Primary outcome: Circadian Phase Marker, as Measured by the Melatonin Levels in Serial Salivary and/or Plasma Samples.

Time frame: biweekly throughout the entire study

Population analysed: The PI has retired from the institution. Sincere efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events
Melatonin: 0.025 Mg-0.5 mg (Delay Timing)	0 of 0	0 of 0
Melatonin: 0.025 mg - 0.5 mg (Advance Timing)	0 of 0	0 of 0
Melatonin: 0.025 mg - 10 mg (Advance Timing)	0 of 0	0 of 0
Melatonin: 0.025 mg - 20 mg (Advance Timing)	0 of 0	0 of 0

Limitations and caveats (from the sponsor): Analyses were not completed because, a unique provision in the American Recovery and Reinvestment Act (ARRA) of 2009 funding source unexpectedly prevented approval of a second year no-cost-extension in which completion of analyses were planned.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 10810544Lewy AJ. Melatonin as a marker and phase-resetter of circadian rhythms in humans. Adv Exp Med Biol. 1999;460:425-34. doi: 10.1007/0-306-46814-x_51. No abstract available.
Background: PubMed 11027741Sack RL, Brandes RW, Kendall AR, Lewy AJ. Entrainment of free-running circadian rhythms by melatonin in blind people. N Engl J Med. 2000 Oct 12;343(15):1070-7. doi: 10.1056/NEJM200010123431503.
Background: PubMed 11684046Lewy AJ, Bauer VK, Hasler BP, Kendall AR, Pires ML, Sack RL. Capturing the circadian rhythms of free-running blind people with 0.5 mg melatonin. Brain Res. 2001 Nov 9;918(1-2):96-100. doi: 10.1016/s0006-8993(01)02964-x.
Results publication: PubMed 16393710Lewy AJ, Emens JS, Lefler BJ, Yuhas K, Jackman AR. Melatonin entrains free-running blind people according to a physiological dose-response curve. Chronobiol Int. 2005;22(6):1093-106. doi: 10.1080/07420520500398064.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Alfred J Lewy, MD, PhD principal investigator

Oregon Health and Science University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Melatonin in people with Blindness, run by Oregon Health and Science University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 27 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Circadian Phase Marker, as Measured by the Melatonin Levels in Serial Salivary and/or Plasma Samples. (time frame: biweekly throughout the entire study). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00692094, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2019.