Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01AG021826 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Unique provision in the American Recovery and Reinvestment Act prevented approval of second year no-cost-extension in which completion of analyses were planned.
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Melatonin | Biological | 0.025 mg-0.5 mg, daily given at a time when it is expected to delay the timing of the body clock. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Circadian Phase Marker, as Measured by the Melatonin Levels in Serial Salivary and/or Plasma Samples. | biweekly throughout the entire study |
| Measure | Description | Time Frame |
|---|---|---|
| Durability and Toxicity Side Effects Questionnaire | 1 year |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Alfred J Lewy, MD, PhD | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sleep and Mood Disorders Lab, Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10810544 | Background | 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. | |
| 11027741 | Background | 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. |
Not provided
Not provided
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.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Circadian Phase Marker, as Measured by the Melatonin Levels in Serial Salivary and/or Plasma Samples. | 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. | Posted | biweekly throughout the entire study |
|
Not provided
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
Not provided
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| OHSU Integrity Department | Oregon Health and Science University | 1-877-733-8313 | irb@ohsu.edu |
Not provided
| ID | Term |
|---|---|
| D001766 | Blindness |
| ID | Term |
|---|---|
| D014786 | Vision Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D008550 | Melatonin |
| ID | Term |
|---|---|
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Melatonin | Biological | 0.025 mg - 0.5 mg, daily, at a time when melatonin should advance the timing of their body clock. |
|
| Melatonin | Biological | 0.025 mg - 10 mg, daily, at a time when melatonin should advance the timing of their body clock. |
|
| Melatonin | Biological | 0.025 mg - 20 mg, daily, at a time when the melatonin should advance the timing of the body clock. |
|
| 11684046 | Background | 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. |
| 16393710 | Result | 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
|
| Age, Continuous |
| Sex: Female, Male |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. |
| Region of Enrollment | participants |
|
| 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. |
| OG002 | 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. |
| OG003 | 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. |
|
| Secondary | Durability and Toxicity Side Effects Questionnaire | 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. | Posted | 1 year |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
Not provided
Not provided
| D005128 |
| Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006571 | Heterocyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |