Trial Outcomes & Findings for Blind Elderly Melatonin Treatment Study (NCT NCT00692094)
NCT ID: NCT00692094
Last Updated: 2019-11-27
Results Overview
TERMINATED
NA
12 participants
biweekly throughout the entire study
2019-11-27
Participant Flow
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.
Participant milestones
| Measure |
Melatonin: 0.025 Mg-0.5 mg (Delay Timing)
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.
Melatonin: 0.025 mg-0.5 mg, daily given at a time when it is expected to delay the timing of the body clock.
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Melatonin: 0.025 mg - 0.5 mg (Advance Timing)
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.
Melatonin: 0.025 mg - 0.5 mg, daily, at a time when melatonin should advance the timing of their body clock.
|
Melatonin: 0.025 mg - 10 mg (Advance Timing)
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.
Melatonin: 0.025 mg - 10 mg, daily, at a time when melatonin should advance the timing of their body clock.
|
Melatonin: 0.025 mg - 20 mg (Advance Timing)
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.
Melatonin: 0.025 mg - 20 mg, daily, at a time when the melatonin should advance the timing of the body clock.
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Overall Study
STARTED
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Overall Study
COMPLETED
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0
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0
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Blind Elderly Melatonin Treatment Study
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: biweekly throughout the entire studyPopulation: 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearPopulation: 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.
Outcome measures
Outcome data not reported
Adverse Events
Melatonin: 0.025 Mg-0.5 mg (Delay Timing)
Melatonin: 0.025 mg - 0.5 mg (Advance Timing)
Melatonin: 0.025 mg - 10 mg (Advance Timing)
Melatonin: 0.025 mg - 20 mg (Advance Timing)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
OHSU Integrity Department
Oregon Health and Science University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place