Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0158108034
Study information
Scientific title
Acronym
Study hypothesis
To assess the efficacy of light therapy in the treatment of PMS.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Urological and Genital Diseases: Premenstrual syndrome (PMS)
Intervention
Women will be recruited from PMS clinics, GP surgeries and through the media. They will record symptoms daily for two cycles. A structured clinical interview for DSM IV personality disorders (SCID) will be carried out 1 month single blind, to exclude placebo responders.
Randomised to either actual or placebo light masks. They will continue to keep a daily diary.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Reduction in the overall score for PMS symptomatology
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/06/2002
Overall trial end date
01/06/2005
Reason abandoned
Eligibility
Participant inclusion criteria
Women between 18 and 45 years of age with regular menstrual cycles who meet the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM IV) criteria for premenstrual dysphoric disorder (PMDD). They need to be able to write and read English.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/06/2002
Recruitment end date
01/06/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Obstetrics and Gynaecology Academic Department
Stoke-on-Trent
ST4 6QG
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
North Staffordshire Research and Development Consortium (UK)
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