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NCT Number: NCT06871345

Perimenstrual Symptoms and Emotional Dysregulation in Autism

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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;
  • 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

Exclusion criteria

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;
  • 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;

Treatment and study plan

Semi-structured interviews SCID

Other

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 questionnaires

Other

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).

Primary outcomes

  1. 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)

Secondary outcomes

  1. The impact of the menstrual cycle on emotional manifestations

    Time frame: 3 months

    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)

  2. The impact of the menstrual cycle on cognitive manifestations

    Time frame: 3 months

    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)

  3. The impact of the menstrual cycle on behavioral manifestations

    Time frame: 3 months

    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)

  4. Subjective differences in real-life emotional experience between ASD, BPD, PMDD and healthy volunteers

    Time frame: 3 months

    Premenstrual dysphoric symptoms scores

  5. Cognitive correlates of emotional dysregulation by phase of the menstrual cycle

    Time frame: 3 months

    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;

  6. 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

    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)

  7. Evaluate the intensity of dysphoric symptoms during two menstrual cycles

    Time frame: 3 months

    Comparison of all these assessments between the groups (autistic women, women with borderline personality disorder, women with PMDD, and control group).

  8. Understand the impact of these dysphoric symptoms during two menstrual cycles

    Time frame: 3 months

    Comparison of all these assessments between the groups (autistic women, women with borderline personality disorder, women with PMDD, and control group).

  9. The evolution of the emotional experience, assessed in daily life, during two menstrual cycles

    Time frame: 3 months

    Comparison of all these assessments between the groups (autistic women, women with borderline personality disorder, women with PMDD, and control group).

  10. The evolution of cognitive functioning underlying emotional dysregulation, over the course of two menstrual cycles

    Time frame: 3 months

    Comparison of all these assessments between the groups (autistic women, women with borderline personality disorder, women with PMDD, and control group).

  11. 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

    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);

  12. The evolution of self-reported emotional dysregulation assessed in daily life during two menstrual cycles

    Time frame: 3 months

    Comparison of all these assessments between the groups (autistic women, women with borderline personality disorder, women with PMDD, and control group).

Study contacts

Contact information is provided by the study sponsor or research team.

Luisa WEINER, Professor

CONTACT

[email protected]

0388116511

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Official study title

Evaluation of the Links Between Perimenstrual Symptoms and Emotional Dysregulation in Autistic Individuals: Ecological, Subjective, and Cognitive Approach

Acronym: MEDEA

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Mar 11, 2025
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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