(1) To investigate the relationship between estradiol level and ADHD and mood symptoms within the menstrual cycle in women with ADHD. (2) To investigate if this relationship is comparable between 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 intra-individual diferences between the three time points (at low,
intermediate and high estradiol niveau) on the ADHD-RS within the ADHD group.
Covariates and/or confounders are the objective sleep-wake rhythm, subjective
fatigue, background variables such as age, educational leven, comorbid
psychiatric disorders (incl. PMDD),smoking status, use of medication, and
progesterone, LH, FSH, DHEA-S levels.
Secondary outcome
The three time points (at low, intermediate and high estradiol niveau),
subjective ADHD-RS scores, objective QbTest scores, subjective QIDS scores of
the women with and without ADHD. Covariates and/or confounders are the
objective sleep-wake rhythm, subjective fatigue, background variables such as
age, educational leven, comorbid psychiatric disorders (incl. PMDD),smoking
status, use of medication, and progesterone, LH, FSH, DHEA-S levels.
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
(1) To investigate the relationship between estradiol level and ADHD and mood
symptoms within the menstrual cycle in women with ADHD.
(2) To investigate if this relationship is comparable between 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 during two consecutive menstrual cycle months (time investment
about 1 hour in total), and the study measurements in the third month: 3x vena
puncture for the measurement of hormone levels in blood, one month of wrist
Actigraphy (instruction time 30 minutes), 3x objective QbTest assessments (time
investment 2 hours), 3x filling out questionnaires (ADHD-RS, QIDS, and a sleep
questionnaire; time investment 1,5 hours in total). Total time investment: 6
hours, plus travel time.
Carel Reinierszkade 197
Den Haag 2593 HR
NL
Carel Reinierszkade 197
Den Haag 2593 HR
NL
Listed location countries
Age
Inclusion criteria
ADHD and controls:
- Female gender
- Age 18-45 years old
- regular menstrual cycle
- able to fill out Dutch questionnaires
For ADHD group: ADHD diagnosis
Exclusion criteria
- use of hormones
- use of ADHD medication
- use of sleep medication
- alcohol or drug abuse disorder
- a psychiatric disorder that needs immediate treatment
- any somatic disease affecting sleep or the menstrual cycle (e.g. diabetes)
For control group:
- positive screen for ADHD
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 | NL70774.058.19 |