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ISRCTN
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ISRCTN55452501
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ClinicalTrials.gov identifier
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Public title
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Illumination in human aging: sleep and mood effects
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Scientific title
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Acronym
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LRX
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Serial number at source
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5 RO1 AG12364-11A1
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Study hypothesis
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Bright white light would reduce depression and improve sleep disorders related to circadian rhythm disturbance.
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Lay summary
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Ethics approval
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The study protocol and consent form were approved by the University of California and San Diego (UCSD) Human Research Protection Program.
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Study design
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Randomised controlled trial
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Countries of recruitment
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United States of America
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Disease/condition/study domain
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Depression and disturbed sleep
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Participants - inclusion criteria
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1. Humans aged 60 - 79 years
2. No history of mania
3. No diagnosis of bipolar disorder
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Participants - exclusion criteria
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Lifetime history of mania.
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Anticipated start date
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01/04/2000
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Anticipated end date
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31/01/2004
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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81
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Interventions
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One hour bright white light compared to one hour dim red light at three different times of day.
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Primary outcome measure(s)
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1. Mood scales
2. Light recording
3. Wrist actigraphy
4. Assays of urine for aMT6s
5. Assays of saliva for melatonin
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Secondary outcome measure(s)
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No secondary outcome measures
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Sources of funding
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National Institutes of Health (NIH)/National Institute of Aging (NIA) (USA) (ref: 5 RO1 AG12364-11A1)
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Trial website
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Publications
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Results in http://www.ncbi.nlm.nih.gov/pubmed/16283925
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Contact name
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Prof
Daniel
Kripke
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Address
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9500 Gillman Drive
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City/town
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La Jolla, CA
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Zip/Postcode
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92093-0667
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Country
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United States of America
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Sponsor
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National Institutes of Health (NIH)/National Institute of Aging (NIA) (USA)
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Address
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7201 Wisconsin Ave.
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City/town
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Bethesda, MD
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Zip/Postcode
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20892
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Country
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United States of America
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Sponsor website:
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http://www.nia.nih.gov/
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Date applied
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06/05/2005
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Last edited
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14/02/2008
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Date ISRCTN assigned
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11/05/2005
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