Sleep and melatonin secretion in women with severe premenstrual disorder

Completed

• Conditions: Premenstrual dysphoric disorder (PMDD); Urological and Genital Diseases

• Registration Number: ISRCTN96702191
• Lead Sponsor: Douglas Mental Health University Institute (Canada)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02-07
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 18

Inclusion Criteria

Patients:
1. Females aged between 18 and 45 years old
2. Meet Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) research criteria for clinical diagnosis of PMDD. This was determined by meeting with a trained psychiatrist during the asymptomatic follicular phase and the symptomatic late luteal phase.
3. Required to fill out an 11-item visual analogue scale (VAS) for at least two consecutive menstrual cycles. The 11-item VAS (10-mm bipolar scale, with 0 mm being not at all and 100 mm being extreme symptoms) was based on the DSM-IV criteria for PMDD diagnoses and included the measures depressed mood, tension, affective lability, irritability, decreased interest, difficulty concentrating, lack of energy, change in appetite, change in sleep patterns, feeling out of control, and physical symptoms. An individual mean score for each of the four core PMDD symptoms (depressed mood, tension, affective lability and irritability) was calculated for days 6 - 10 after menstruation and also for the last 5 days of the menstrual cycle (late luteal phase). Eligibility criteria required an increase of at least 200% on one, or at least 100% on two or more of the core symptoms for the mean late luteal phase score compared to the follicular phase.

Age-matched controls:
4. Completed the VAS during screening and who showed no evidence of PMDD or any other psychiatric disorder

Both groups:
5. All participants had a history of regular menstrual cycles (range: 25-34 +/- 3 days)

Exclusion Criteria

1. Diagnosed with seasonal affective disorder (SAD) or any other Axis I or II disorder
2. Drug use
3. Oral contraceptives
4. History of gynecological pathology
5. History of night-shift work or transmeridian travel within three months prior to study

Study & Design

• Study Type: Interventional
• Study Design: Not specified