To investigate the relationship between subjective and objective ADHD and subjective mood symptoms and the menstrual phase in women with and without ADHD.
ID
Source
Brief title
Condition
- Cognitive and attention disorders and disturbances
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The mean outcomes of the ADHD-RS and the QbTests at the three time points
within the ADHD group.
Secondary outcome
Comparison between the groups per time point of the ADHD-RS, QbTest, and QIDS.
Background summary
Women with ADHD have more often and more severe premenstrual mood disorder
symptoms (PMDD), compared to women without ADHD, as was shown in our previous
research (46% vs. 3-8%). Dopamine and estradiol levels seem to enhance each
other. As ADHD is associated with low dopamine neurotransmission, the
hypothesis is that ADHD symptoms and mood instability may increase in the low
estradiol (premenstrual) phase of the cycle. Regarding the sleep rhythm, in
women with PMDD compared to controls, changes in the circadian sleep rhythm
have been found, indicating that disturbed sleep may also contribute to the
mood symptoms.
Study objective
To investigate the relationship between subjective and objective ADHD and
subjective mood symptoms and the menstrual phase in women with and without
ADHD.
Study design
Prospective observational case-control study
Study burden and risks
The burden for the participants consists of monitoring the severity of mood and
ADHD symptoms (each evaluated by a rating 1-10 per day) during two consecutive
months (time investment about 1 hour in total), prior to inclusion in the study
(as required according to DSM-5 criteria for a diagnosis of PMDD), and the
study measurements in the third month: 3x measurement of hormone levels in
blood samples after a vena puncture, 3 x 3 days of wrist Actigraphy
(instruction time 30 minutes), 3x objective QbTest assessments (time investment
2 hours), filling out questionnaires (MCTQ once; ADHD-RS, QIDS, and sleep
questionnaire three times; time investment 1,5 hours in total).
Carel Reinierszkade 197
Den Haag 2593 HR
NL
Carel Reinierszkade 197
Den Haag 2593 HR
NL
Listed location countries
Age
Inclusion criteria
- Female gender
- Age 18-45 years old
- regular menstrual cycle
- no use of hormones
- no use of ADHD medication
For ADHD group: ADHD diagnosis
Exclusion criteria
For controle group:
- ADHD diagnosis or fullfill criteria for ADHD diagnosis
Design
Recruitment
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL68830.098.19 |