ISRCTN ISRCTN55452501
DOI https://doi.org/10.1186/ISRCTN55452501
Secondary identifying numbers 5 RO1 AG12364-11A1
Submission date
06/05/2005
Registration date
11/05/2005
Last edited
14/02/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Daniel Kripke
Scientific

9500 Gillman Drive
La Jolla, CA
92093-0667
United States of America

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study acronymLRX
Study objectivesBright white light would reduce depression and improve sleep disorders related to circadian rhythm disturbance.
Ethics approval(s)The study protocol and consent form were approved by the University of California and San Diego (UCSD) Human Research Protection Program.
Health condition(s) or problem(s) studiedDepression and disturbed sleep
InterventionOne hour bright white light compared to one hour dim red light at three different times of day.
Intervention typeOther
Primary outcome measure1. Mood scales
2. Light recording
3. Wrist actigraphy
4. Assays of urine for aMT6s
5. Assays of saliva for melatonin
Secondary outcome measuresNo secondary outcome measures
Overall study start date01/04/2000
Completion date31/01/2004

Eligibility

Participant type(s)Patient
Age groupSenior
SexAll
Target number of participants81
Key inclusion criteria1. Humans aged 60 - 79 years
2. No history of mania
3. No diagnosis of bipolar disorder
Key exclusion criteriaLifetime history of mania.
Date of first enrolment01/04/2000
Date of final enrolment31/01/2004

Locations

Countries of recruitment

  • United States of America

Study participating centre

9500 Gillman Drive
La Jolla, CA
92093-0667
United States of America

Sponsor information

Funders

Funder type

Government

National Institutes of Health (NIH)/National Institute of Aging (NIA) (USA) (ref: 5 RO1 AG12364-11A1)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article Results 09/11/2005 Yes No