Condition category
Mental and Behavioural Disorders
Date applied
06/05/2005
Date assigned
11/05/2005
Last edited
14/02/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Daniel Kripke

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

5 RO1 AG12364-11A1

Study information

Scientific title

Acronym

LRX

Study hypothesis

Bright white light would reduce depression and improve sleep disorders related to circadian rhythm disturbance.

Ethics approval

The study protocol and consent form were approved by the University of California and San Diego (UCSD) Human Research Protection Program.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Depression and disturbed sleep

Intervention

One hour bright white light compared to one hour dim red light at three different times of day.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Mood scales
2. Light recording
3. Wrist actigraphy
4. Assays of urine for aMT6s
5. Assays of saliva for melatonin

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/04/2000

Overall trial end date

31/01/2004

Reason abandoned

Eligibility

Participant inclusion criteria

1. Humans aged 60 - 79 years
2. No history of mania
3. No diagnosis of bipolar disorder

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

81

Participant exclusion criteria

Lifetime history of mania.

Recruitment start date

01/04/2000

Recruitment end date

31/01/2004

Locations

Countries of recruitment

United States of America

Trial participating centre

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

Sponsor information

Organisation

National Institutes of Health (NIH)/National Institute of Aging (NIA) (USA)

Sponsor details

7201 Wisconsin Ave.
Bethesda
MD
20892
United States of America

Sponsor type

Government

Website

http://www.nia.nih.gov/

Funders

Funder type

Government

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results in http://www.ncbi.nlm.nih.gov/pubmed/16283925

Publication citations

  1. Results

    Loving RT, Kripke DF, Elliott JA, Knickerbocker NC, Grandner MA, Bright light treatment of depression for older adults [ISRCTN55452501]., BMC Psychiatry, 2005, 5, 41, doi: 10.1186/1471-244X-5-41.

Additional files

Editorial Notes