Perimenstrual Symptoms and Emotional Dysregulation in Autism

Launched by UNIVERSITY HOSPITAL, STRASBOURG, FRANCE · Mar 6, 2025

Keywords

ClinConnect Summary

This clinical trial is focused on understanding emotional dysregulation (ED) in women with Autism Spectrum Disorder (ASD) and Borderline Personality Disorder (BPD). Emotional dysregulation means having trouble managing emotions, which can be very intense and last a long time. The study aims to see how ED changes throughout a woman’s menstrual cycle and to compare these changes with women who have BPD and those who do not have any psychiatric disorders. By learning more about these connections, researchers hope to find better treatments for women experiencing these difficulties.

To participate in the study, women must be between 18 and 45 years old, have regular menstrual cycles, and not be using hormonal birth control. They should also own a smartphone and be able to provide informed consent, meaning they understand what the study involves. Women with a diagnosis of ASD (without intellectual disability) or BPD can join, while those with certain other mental health conditions or severe health issues will not be eligible. Participants will be asked to track their emotional experiences in their everyday lives during their menstrual cycle, which helps researchers gather real-life data about how emotions fluctuate.

Gender

FEMALE

Eligibility criteria

• 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:
• • Patient with a diagnosis of Autism Spectrum Disorder without intellectual disability (ASD), according to the criteria of the DSM-5 OR
• • Patient with a diagnosis of BPD, according to DSM-5 criteria
• 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;
• • Woman on psychotropic therapy or treatment that modifies physiological parameters (e.g., beta-blockers).