Condition category
Urological and Genital Diseases
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
22/09/2014
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

Dr PMS O'Brien

ORCID ID

Contact details

Obstetrics and Gynaecology Academic Department
Maternity Block
City General
Newcastle Road
Stoke-on-Trent
ST4 6QG
United Kingdom
+44 (0)1782 554998

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

http://www.doh.gov.uk

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

Publication citations

Additional files

Editorial Notes