An interventional study of Melatonin and Melatonin in Blindness, sponsored by Oregon Health and Science University. Terminated at 1 site in United States. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2019-11-27.
Sponsored by Oregon Health and Science University · Not applicable, Interventional, and Treatment
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.
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).
161 studies on the registry are indexed under Blindness; 33 are open to participants now.
This study's enrollment of 12 is below the median of 30 across 105 interventional studies indexed under Blindness.
Browse Blindness studies →Oregon Health and Science University is the lead sponsor of 676 studies on the registry; 136 are open to participants now.
Of its 49 completed or terminated interventional studies of FDA-regulated products, 36 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Biological: Melatonin
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.
Biological: Melatonin
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.
Biological: Melatonin
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.
Biological: Melatonin
0.025 mg-0.5 mg, daily given at a time when it is expected to delay the timing of the body clock.
0.025 mg - 0.5 mg, daily, at a time when melatonin should advance the timing of their body clock.
0.025 mg - 10 mg, daily, at a time when melatonin should advance the timing of their body clock.
0.025 mg - 20 mg, daily, at a time when the melatonin should advance the timing of the body clock.
Circadian Phase Marker, as Measured by the Melatonin Levels in Serial Salivary and/or Plasma Samples.
Time frame: biweekly throughout the entire study
Durability and Toxicity Side Effects Questionnaire
Time frame: 1 year
| Milestone | 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) |
|---|---|---|---|---|
| Started | 0 | 0 | 0 | 0 |
| Completed | 0 | 0 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 |
No measurements were reported for this outcome.
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 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) | — | — | — |
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.
| Age, Categorical | 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) | Total |
|---|---|---|---|---|---|
| <=18 years | — | — | — | — | — |
| Between 18 and 65 years | — | — | — | — | — |
| >=65 years | — | — | — | — | — |
| Age, Continuous | 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) | Total |
|---|
| Sex: Female, Male | 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) | Total |
|---|---|---|---|---|---|
| Female | — | — | — | — | — |
| Male | — | — | — | — | — |
| Race and Ethnicity Not Collected | 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) | Total |
|---|
| Region of Enrollment(participants) | 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) | Total |
|---|
This study is terminated, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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Oregon Health and Science University