Trial record 12 of 32 for:    sleep | NICHD

Blind Child Melatonin Treatment Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Oregon Health and Science University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alfred Lewy, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00691444
First received: June 3, 2008
Last updated: November 9, 2013
Last verified: November 2013
  Purpose

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 Intervention
Blindness
Dietary Supplement: Melatonin
Biological: Melatonin

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Melatonin Studies of Blind Children

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Durability and Toxicity Side Effects Questionnaire [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 26
Study Start Date: September 2002
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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).

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).


Detailed Description:

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).

  Eligibility

Ages Eligible for Study:   5 Years to 20 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Investigators
Principal Investigator: Alfred J Lewy, MD, PhD Oregon Health and Science University
  More Information

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, R01 HD42125
Study First Received: June 3, 2008
Last Updated: November 9, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Oregon Health and Science University:
melatonin
circadian rhythms
sleep

Additional relevant MeSH terms:
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 16, 2014