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NCT06871345Not yet recruiting

Perimenstrual Symptoms and Emotional Dysregulation in Autism

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

Source: ClinicalTrials.gov · Last updated 12 May 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
90 (estimated)
First submitted
26 Feb 2025
Start date
1 May 2026
Primary completion date
1 May 2029
Lead sponsor
University Hospital, Strasbourg, France
Diseases
Autism
NCT number
NCT06871345

What you commit to

  • Study type: Interventional
  • Planned participants: 90
  • From 1 May 2026 to the primary completion date, 1 May 2029
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Taking hormonal treatment or synthetic steroids;
  • Woman using hormonal contraceptives (pill, patch, hormonal IUD, vaginal ring, implant, intramuscular injection);

Other illness

  • 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 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;

Other

  • Non-inclusion criteria common to healthy patients and volunteers:
  • 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 co-occurring ASD and BPD;
  • Patient with an intellectual disability (IQ ≤ 70);
  • Patient with neurological comorbidity (e.g., acquired brain injury);

Who the study is looking for

  • 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

Age in the registry: 18 years to 45 years · Sex: Female · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.