Perimenstrual Symptoms and Emotional Dysregulation in Autism

Starting soon · Not applicable

Conditions studied: Autism Spectrum Disorder, Borderline Personality Disorder BPD, a Premenstrual Dysphoric Disorder (PMDD)

In brief

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.

Key facts

Study ID

NCT06871345

Run by

University Hospital, Strasbourg, France

People needed

90

Starts

2026-05-01

Expected to finish

2029-07-01

Last updated by the study team

2026-05-12

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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;

Full record on ClinicalTrials.gov

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