Autism Spectrum DisorderMEDEANCT06871345
Perimenstrual Symptoms and Emotional Dysregulation in Autism
A study testing Semi-structured interviews SCID, Self-report questionnaires and Momentary Ecological Assessment (EMA) in people with Autism Spectrum Disorder and Borderline Personality Disorder BPD, run by University Hospital, Strasbourg, France.
Trial summary
Emotional dysregulation (ED) is defined by difficulties in modulating the experience and expression of emotions, which are characterized by particularly marked reactivity, intensity, and duration. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder, Borderline Personality Disorder BPD, a Premenstrual Dysphoric Disorder (PMDD)
- What is being tested?
- Semi-structured interviews SCID, Self-report questionnaires and Momentary Ecological Assessment (EMA)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 1 Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Common Inclusion Criteria for Healthy Patients and Volunteers:
- Female aged 18 to 45;
- Woman with regular menstrual cycles (variations in duration, measured between the shortest menstrual cycle) and the longest cycle, remain strictly less than 7 days) between 25 and 35 days;
- Woman without hormonal contraception (or NON-hormonal copper IUD) or who has stopped contraception for more than 3 months (and does not wish to take it again);
- Woman with a smartphone with an internet connection;
- Woman able to understand the objectives and risks of the research and to give informed, dated and signed consent;
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- Woman affiliated to a social protection health insurance scheme, beneficiary or beneficiary.
- Patient-specific inclusion criteria:
- Specific inclusion criteria for female patients
- Patient with a diagnosis of Autism Spectrum Disorder without intellectual disability (ASD), according to DSM-5 criteria OR
- Patient with a diagnosis of BPD, according to DSM-5 criteria OR
- Patient meeting the diagnostic criteria for PMDD with the SCID
Who cannot join
- Non-inclusion criteria common to healthy patients and volunteers:
- Taking hormonal treatment or synthetic steroids;
- Woman using hormonal contraceptives (pill, patch, hormonal IUD, vaginal ring, implant, intramuscular injection);
- Pregnancy or breastfeeding on the declaration of the person for less than 3 months;
- Desire to become pregnant within 3 months of inclusion;
- Endocrinopathies (in particular clinical signs of hyperandrogenism) or untreated gynaecological pathologies that may influence menstrual cycles and/or ovulation;
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- Participation in another study that may interfere with the study;
- Inability to give the person informed information (person in an emergency or life-threatening situation);
- Woman under judicial protection;
- Woman under guardianship or curatorship;
- Woman hospitalized for a period > 24 hours
- Patient-specific non-inclusion criteria:
- Patient with a diagnosis of psychotic disorder;
- Patient with a diagnosis of severe substance use disorder, i.e., presence of 6 or more symptoms;
- Patient with a diagnosis of bipolar disorder type I or II or cyclothymia;
- Patient with a diagnosis of co-occurring ASD and BPD;
- Patient with an intellectual disability (IQ ≤ 70);
- Patient with neurological comorbidity (e.g., acquired brain injury);
- Patient on treatment that alters physiological response (heart rhythm, e.g., beta-blockers).
- Non-inclusion criteria specific to healthy volunteers:
- Woman with a psychiatric, neurodevelopmental, or neurological history;
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of the Links Between Perimenstrual Symptoms and Emotional Dysregulation in Autistic Individuals: Ecological, Subjective, and Cognitive Approach
Emotional dysregulation (ED) is defined by difficulties in modulating the experience and expression of emotions, which are characterized by particularly marked reactivity, intensity, and duration. To improve the understanding of ED, its consequences in autistic women, and to be able to offer them appropriate treatments, it seems crucial to investigate the links between ED, known adversities during childhood, and premenstrual dysphoric symptoms. This study aims to characterize the variability of ED throughout a menstrual cycle by measuring it in an ecological real-life context. The variability of ED will be compared to that of women with borderline personality disorder (BPD), women with premenstrual dysphoric disorder (PMDD), and women without a diagnosed disorder.
- Conditions
- Autism Spectrum Disorder, Borderline Personality Disorder BPD, a Premenstrual Dysphoric Disorder (PMDD)
- Being tested
- Semi-structured interviews SCID, Self-report questionnaires, Momentary Ecological Assessment (EMA)
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semi-structured interviews SCIDOther
Structured Clinical Interview for DSM-5 Personality Disorder (SCID) :
The SCID is a 90-item semi-structured interview, covering all 10 categories of personality disorder as described in the DSM-5. Each item is rated on a three-point scale: "absent", "subclinical level" and "present".
Self-report questionnairesOther
Participants will complete a battery of self-report questionnaires, assessing emotional dysregulation (including SRD, the primary endpoint), childhood adversity, anxiety, depression, and premenstrual symptoms.
Momentary Ecological Assessment (EMA)Other
A momentary ecological assessment protocol will be proposed between the inclusion visit and the end-of-protocol visit in order to evaluate emotional and symptomatic dynamics in a daily life context. For two menstrual cycles, subjects will be invited, via their smartphone, to make daily recordings (prompted by SMS) of their subjective emotional experiences (3 times/day).
| Study group | Role | What they receive |
|---|---|---|
| Healthy voluntary group | Active comparator | 20 menstruating women with a regular menstrual cycle that lasts between 25 and 35 days, not using hormonal contraception and without a psychiatric and/or neurological diagnosis. Receives: Other: Semi-structured interviews SCID; Other: Self-report questionnaires; Other: Momentary Ecological Assessment (EMA) |
| Autism female patients group | Experimental | 20 female patients with a diagnosis of Autism Spectrum Disorder (ASD), according to DSM-5 criteria. Receives: Other: Semi-structured interviews SCID; Other: Self-report questionnaires; Other: Momentary Ecological Assessment (EMA) |
| Group of female patients with BPD | Experimental | 20 female patients with a diagnosis of BPD, according to DSM-5 criteria. Receives: Other: Semi-structured interviews SCID; Other: Self-report questionnaires; Other: Momentary Ecological Assessment (EMA) |
| Group of female patients with PMDD | Other | 20 patients with a diagnosis of PMDD, according to DSM-5 criteria Receives: Other: Semi-structured interviews SCID; Other: Self-report questionnaires; Other: Momentary Ecological Assessment (EMA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The links between emotional dysregulation and premenstrual dysphoric symptoms in autistic women compared to women with borderline personality disorder, women with premenstrual dysphoric disorder compared to women without a diagnosed psychiatr
Comparison between groups (autistic people, people with BPD, people with PMDD, people without disorder) of the intensity of EA assessed using self-questionnaires according to the phase of the menstrual cycle (follicular phase, luteal phase, and late luteal phase)
Measured: 3 months
Secondary outcomes (12)
The impact of the menstrual cycle on emotional manifestations
Correlation and mediation between scores on scales regarding emotional dysregulation (DERS-16, BEDS, TAS-20, FREE), childhood adversities (CTQ), and premenstrual dysphoric symptoms (PSST, DRSP)
Measured: 3 months
The impact of the menstrual cycle on cognitive manifestations
Correlation and mediation between scores on scales regarding emotional dysregulation (DERS-16, BEDS, TAS-20, FREE), childhood adversities (CTQ), and premenstrual dysphoric symptoms (PSST, DRSP)
Measured: 3 months
The impact of the menstrual cycle on behavioral manifestations
Correlation and mediation between scores on scales regarding emotional dysregulation (DERS-16, BEDS, TAS-20, FREE), childhood adversities (CTQ), and premenstrual dysphoric symptoms (PSST, DRSP)
Measured: 3 months
Subjective differences in real-life emotional experience between ASD, BPD, PMDD and healthy volunteers
Premenstrual dysphoric symptoms scores
Measured: 3 months
Cognitive correlates of emotional dysregulation by phase of the menstrual cycle
Comparison of scores obtained on scales assessing emotional dysregulation (DERS-16, BEDS, TAS-20, FREE), borderline traits (BSL-23), autistic traits (AQ), anxious traits (EDAS-21), and depressive traits (EDAS-21, BDI) in the follicular phase and in the late luteal phase of the menstrual cycle;
Measured: 3 months
The concordance between subjective and cognitive measures of emotional dysregulation, assessed in daily life, in ASD, BPD, PMDD and healthy volunteers
Comparison of the frequency, intensity, and variability of emotional responses recorded in real-life contexts (ecological momentary assessment - EMA) according to the phase of the menstrual cycle (follicular phase, luteal phase, and late luteal phase)
Measured: 3 months
Evaluate the intensity of dysphoric symptoms during two menstrual cycles
Comparison of all these assessments between the groups (autistic women, women with borderline personality disorder, women with PMDD, and control group).
Measured: 3 months
Understand the impact of these dysphoric symptoms during two menstrual cycles
Comparison of all these assessments between the groups (autistic women, women with borderline personality disorder, women with PMDD, and control group).
Measured: 3 months
The evolution of the emotional experience, assessed in daily life, during two menstrual cycles
Comparison of all these assessments between the groups (autistic women, women with borderline personality disorder, women with PMDD, and control group).
Measured: 3 months
The evolution of cognitive functioning underlying emotional dysregulation, over the course of two menstrual cycles
Comparison of all these assessments between the groups (autistic women, women with borderline personality disorder, women with PMDD, and control group).
Measured: 3 months
The association between subjective and cognitive measures of emotional dysregulation, assessed in consultation, in ASD compared to BPD, PMDD, and healthy volunteers
Comparison of performance on the emotional Stroop task proposed in daily life according to the phase of the menstrual cycle (follicular phase, luteal phase, and late luteal phase);
Measured: 3 months
The evolution of self-reported emotional dysregulation assessed in daily life during two menstrual cycles
Comparison of all these assessments between the groups (autistic women, women with borderline personality disorder, women with PMDD, and control group).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start1 May 2026 (estimated)
- Primary completion1 May 2029 (estimated)
- Study completion1 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luisa WEINER, Professor, Principal investigator, Department of Psychiatry II Psychiatry, Mental Health and Addiction Medicine, University Hospitals of Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06871345
- Sponsor's protocol ID
- 9499
- Other IDs
- 2024-A02269-38
- Acronym
- MEDEA
- Status last verified
- May 2026
- First submitted
- 26 Feb 2025
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Links Between Perimenstrual Symptoms and Emotional Dysregulation in Autistic Individuals: Ecological, Subjective, and Cognitive Approach
- ClinicalTrials.gov ID
- NCT06871345
- Acronym / sponsor ID
- MEDEA / 9499
- Conditions
- Autism Spectrum Disorder, Borderline Personality Disorder BPD, a Premenstrual Dysphoric Disorder (PMDD)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 May 2029 (estimated)
- Study completion
- 1 Jul 2029 (estimated)
- First posted
- 11 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Emotional dysregulation (ED) is defined by difficulties in modulating the experience and expression of emotions, which are characterized by particularly marked reactivity, intensity, and duration. To improve the understanding of ED, its consequences in autistic women, and to be able to offer them appropriate treatments, it seems crucial to investigate the links between ED, known adversities during childhood, and premenstrual dysphoric symptoms. This study aims to characterize the variability of ED throughout a menstrual cycle by measuring it in an ecological real-life context. The variability of ED will be compared to that of women with borderline personality disorder (BPD), women with premenstrual dysphoric disorder (PMDD), and women without a diagnosed disorder.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy voluntary group | Active comparator | Other: Semi-structured interviews SCID, Other: Self-report questionnaires, Other: Momentary Ecological Assessment (EMA)20 menstruating women with a regular menstrual cycle that lasts between 25 and 35 days, not using hormonal contraception and without a psychiatric and/or neurological diagnosis. |
| Autism female patients group | Experimental | Other: Semi-structured interviews SCID, Other: Self-report questionnaires, Other: Momentary Ecological Assessment (EMA)20 female patients with a diagnosis of Autism Spectrum Disorder (ASD), according to DSM-5 criteria. |
| Group of female patients with BPD | Experimental | Other: Semi-structured interviews SCID, Other: Self-report questionnaires, Other: Momentary Ecological Assessment (EMA)20 female patients with a diagnosis of BPD, according to DSM-5 criteria. |
| Group of female patients with PMDD | Other | Other: Semi-structured interviews SCID, Other: Self-report questionnaires, Other: Momentary Ecological Assessment (EMA)20 patients with a diagnosis of PMDD, according to DSM-5 criteria |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Female aged 18 to 45;
- Woman with regular menstrual cycles (variations in duration, measured between the shortest menstrual cycle) and the longest cycle, remain strictly less than 7 days) between 25 and 35 days;
- Woman without hormonal contraception (or NON-hormonal copper IUD) or who has stopped contraception for more than 3 months (and does not wish to take it again);
- Woman with a smartphone with an internet connection;
- Woman able to understand the objectives and risks of the research and to give informed, dated and signed consent;
Key exclusion criteria (21 listed)
- Taking hormonal treatment or synthetic steroids;
- Woman using hormonal contraceptives (pill, patch, hormonal IUD, vaginal ring, implant, intramuscular injection);
- Pregnancy or breastfeeding on the declaration of the person for less than 3 months;
- Desire to become pregnant within 3 months of inclusion;
- Endocrinopathies (in particular clinical signs of hyperandrogenism) or untreated gynaecological pathologies that may influence menstrual cycles and/or ovulation;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semi-structured interviews SCIDStructured Clinical Interview for DSM-5 Personality Disorder (SCID) : The SCID is a 90-item semi-structured interview, covering all 10 categories of personality disorder as described in the DSM-5. Each item is rated on a three-point scale: "absent", "subclinical level" and "present". | Other | Autism female patients group, Group of female patients with BPD, Group of female patients with PMDD, Healthy voluntary group |
| Self-report questionnairesParticipants will complete a battery of self-report questionnaires, assessing emotional dysregulation (including SRD, the primary endpoint), childhood adversity, anxiety, depression, and premenstrual symptoms. | Other | Autism female patients group, Group of female patients with BPD, Group of female patients with PMDD, Healthy voluntary group |
| Momentary Ecological Assessment (EMA)A momentary ecological assessment protocol will be proposed between the inclusion visit and the end-of-protocol visit in order to evaluate emotional and symptomatic dynamics in a daily life context. For two menstrual cycles, subjects will be invited, via their smartphone, to make daily recordings (prompted by SMS) of their subjective emotional experiences (3 times/day). | Other | Autism female patients group, Group of female patients with BPD, Group of female patients with PMDD, Healthy voluntary group |
Primary outcome
The links between emotional dysregulation and premenstrual dysphoric symptoms in autistic women compared to women with borderline personality disorder, women with premenstrual dysphoric disorder compared to women without a diagnosed psychiatr
Time frame: 3 months
Comparison between groups (autistic people, people with BPD, people with PMDD, people without disorder) of the intensity of EA assessed using self-questionnaires according to the phase of the menstrual cycle (follicular phase, luteal phase, and late luteal phase)
12 secondary outcomes
The impact of the menstrual cycle on emotional manifestations
Time frame: 3 months
The impact of the menstrual cycle on cognitive manifestations
Time frame: 3 months
The impact of the menstrual cycle on behavioral manifestations
Time frame: 3 months
Subjective differences in real-life emotional experience between ASD, BPD, PMDD and healthy volunteers
Time frame: 3 months
Cognitive correlates of emotional dysregulation by phase of the menstrual cycle
Time frame: 3 months
The concordance between subjective and cognitive measures of emotional dysregulation, assessed in daily life, in ASD, BPD, PMDD and healthy volunteers
Time frame: 3 months
Evaluate the intensity of dysphoric symptoms during two menstrual cycles
Time frame: 3 months
Understand the impact of these dysphoric symptoms during two menstrual cycles
Time frame: 3 months
The evolution of the emotional experience, assessed in daily life, during two menstrual cycles
Time frame: 3 months
The evolution of cognitive functioning underlying emotional dysregulation, over the course of two menstrual cycles
Time frame: 3 months
The association between subjective and cognitive measures of emotional dysregulation, assessed in consultation, in ASD compared to BPD, PMDD, and healthy volunteers
Time frame: 3 months
The evolution of self-reported emotional dysregulation assessed in daily life during two menstrual cycles
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Luisa WEINER, Professor principal investigator
Department of Psychiatry II Psychiatry, Mental Health and Addiction Medicine, University Hospitals of Strasbourg
Questions about this trial
What is this clinical trial studying?
A study testing Semi-structured interviews SCID, Self-report questionnaires and Momentary Ecological Assessment (EMA) in people with Autism Spectrum Disorder and Borderline Personality Disorder BPD, run by University Hospital, Strasbourg, France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luisa WEINER, Professor (0388116511, luisa.weiner@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The links between emotional dysregulation and premenstrual dysphoric symptoms in autistic women compared to women with borderline personality disorder, women with premenstrual dysphoric disorder compared to women without a diagnosed psychiatr (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.