Phenotypes and experiences of reproductive affective disorders among women in the Netherlands

• Conditions: PMS; Premenstrual disorders; 10027946; 10018057

• Registration Number: NL-OMON55939
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 250

Inclusion Criteria

For the observational prospective cohort study women must meet the following
criteria:
All participants must give signed informed consent.
All participants must be of fertile age (16 years of age or older, with a
maximum of 60 years).
Participants must experience self-reported PMS or PMDD related symptoms.
Participants must have a detectable cycle, which may either be a natural
menstrual cycle or induced by hormonal contraceptives, of no longer than 40
days.

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded
from the observational prospective cohort study:
Current pregnancy, or actively trying to conceive
Insufficient proficiency in Dutch

A potential subject who meets any of the following criteria will be excluded
from the validation study:
Current pregnancy, or actively trying to conceive
Insufficient proficiency in Dutch
Any current DSM-5 Axis 1 clinical disorder (other than PMDD) according to the
SCID interview
Current use of psychopharmaceutical medication

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is PMM/PMDD symptomatology as assessed using the<br /><br>C-PASS questionnaire.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary parameters are clinical diagnosis (SCID in validation study only),<br /><br>PMDD symptoms, co-morbid somatic and mental symptoms (GRSR, EPDS, PANAS, PQ-16,<br /><br>BSI-18, ADHD-screener, ASSIST-Lite), personality (DAPP-sf, HSP), quality of<br /><br>life (Q-LES-Q-SF), days of sick leave, disease course, medication use, service<br /><br>use, wellbeing, social functioning, psychiatric symptoms and history. </p><br>