Blind Child Melatonin Treatment Study
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| ClinicalTrials.gov Identifier: NCT00691444 |
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Recruitment Status : Unknown
Verified November 2014 by Alfred Lewy, Oregon Health and Science University.
Recruitment status was: Recruiting
First Posted : June 5, 2008
Last Update Posted : November 6, 2014
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Sponsor:
Oregon Health and Science University
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Alfred Lewy, Oregon Health and Science University
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Brief Summary:
The primary focus of this five-year study will be to optimize the melatonin dosing regimen for synchronizing the body clocks of blind children to the 24-hour day.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Blindness | Dietary Supplement: Melatonin Biological: Melatonin | Not Applicable |
We intend to study as many as 26 blind children through up to three 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 3 treatment plans differ only in the start dose. Successfully treated subjects (of one treatment plan) 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).
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 26 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Participant) |
| Primary Purpose: | Treatment |
| Official Title: | Melatonin Studies of Blind Children |
| Study Start Date : | September 2002 |
| Estimated Primary Completion Date : | March 2015 |
| Estimated Study Completion Date : | March 2015 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Melatonin
| Arm | Intervention/treatment |
|---|---|
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Experimental: 1
Subjects will be given up to 0.5 mg daily. If the treatment works, the dose will be reduced gradually until the lowest, effective dose is identified. If the treatment is unsuccessful, the subject will be taken off treatment and later enrolled in a different treatment plan.
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Dietary Supplement: Melatonin
Subjects will be given up to 0.5 mg daily. 0.005-20 mg, daily, up to 5 years (the exact duration depends on each subjects response to the dose and the specifics of their circadian rhythm patterns). |
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Experimental: 2
Subjects will be given up to 10 mg daily. If the treatment works, the dose will be reduced gradually until the lowest, effective dose is identified. If the treatment is unsuccessful, the subject will be taken off treatment and later enrolled in a different treatment plan.
|
Dietary Supplement: Melatonin
Subjects will be given up to 10 mg daily. 0.005-20 mg, daily, up to 5 years (the exact duration depends on each subjects response to the dose and the specifics of their circadian rhythm patterns). |
|
Experimental: 3
Subjects will be given up to 20 mg daily. If the treatment works, the dose will be reduced gradually until the lowest, effective dose is identified. If the treatment is unsuccessful, the subject will be taken off treatment and later enrolled in a different treatment plan.
|
Biological: Melatonin
Subjects will be given up to 20 mg daily. 0.005-20 mg, daily, up to 5 years (the exact duration depends on each subjects response to the dose and the specifics of their circadian rhythm patterns). |
Primary Outcome Measures :
- circadian phase marker, as measured by the melatonin levels in serial salivary and/or plasma samples. [ Time Frame: biweekly throughout the entire study ]
Secondary Outcome Measures :
- Durability and Toxicity Side Effects Questionnaire [ Time Frame: 1 year ]
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| Ages Eligible for Study: | 5 Years to 20 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Children and adults 5 to 20 years old
- Blindness for at least one year, verified by an ophthalmologic exam
- Ability to comply with the requirements of the experimental protocol
- And no clinically significant abnormalities (other than blindness) on a general physical examination.
- Subjects must be competent to sign informed consent if age 18 or older. Parents and subjects will be interviewed together and, when appropriate (for example, subject is age 18 or older), separately as well.
Exclusion Criteria:
- Abnormal heart, liver or kidney function; intractable seizure disorders
- Significant laboratory abnormalities on CBC, Comprehensive Metabolic set, or UA (dip stick method)
- Pregnancy; sexual activity in post-pubertal females not using a recognized and valid contraceptive method
- A current Axis I psychiatric or substance abuse disorder according to the DSM-IV Manual ; OR
- External demands that limit the ability to maintain a regular schedule, e.g. night shift work.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00691444
Contacts
| Contact: Amber Laurie | 1-866-424-6060 | sleeplab@ohsu.edu | |
| Contact: Alfred J Lewy, MD, PhD | 503-494-7746 | lewy@ohsu.edu |
Locations
| United States, Oregon | |
| Sleep and Mood Disorders Lab, Oregon Health & Science University | Recruiting |
| Portland, Oregon, United States, 97239 | |
| Contact: Amber Laurie, B.A. 866-424-6060 sleeplab@ohsu.edu | |
| Principal Investigator: Alfred J Lewy, MD, PhD | |
| Sub-Investigator: Jonathan S Emens, MD | |
Sponsors and Collaborators
Oregon Health and Science University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
| Principal Investigator: | Alfred J Lewy, MD, PhD | Oregon Health and Science University |
Additional Information:
Publications:
| Responsible Party: | Alfred Lewy, Senior Vice Chair and Professor, Psychiatry, Oregon Health and Science University |
| ClinicalTrials.gov Identifier: | NCT00691444 History of Changes |
| Other Study ID Numbers: |
eIRB 1251 R01HD042125 ( U.S. NIH Grant/Contract ) |
| First Posted: | June 5, 2008 Key Record Dates |
| Last Update Posted: | November 6, 2014 |
| Last Verified: | November 2014 |
Keywords provided by Alfred Lewy, Oregon Health and Science University:
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melatonin circadian rhythms sleep |
Additional relevant MeSH terms:
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Blindness Vision Disorders Sensation Disorders Neurologic Manifestations Nervous System Diseases Eye Diseases Signs and Symptoms |
Melatonin Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs Central Nervous System Depressants |