Perimenstrual Symptoms and Emotional Dysregulation in Autism
NCT06871345, Not applicable, Not yet recruiting, University Hospital, Strasbourg, France
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Perimenstrual Symptoms and Emotional Dysregulation in Autism | ClinicalTrials.gov |
| NCT number | NCT06871345 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 90 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | University Hospital, Strasbourg, France | ClinicalTrials.gov |
| Conditions | Autism Spectrum Disorder, Borderline Personality Disorder BPD, a Premenstrual Dysphoric Disorder (PMDD) | ClinicalTrials.gov |
| Interventions | Semi-structured interviews SCID, Self-report questionnaires, Momentary Ecological Assessment (EMA) | ClinicalTrials.gov |
| First posted | 2025-03-11 | ClinicalTrials.gov |
| Last updated | 2026-05-12 | ClinicalTrials.gov |
Registered outcomes 13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | 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 | 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) | ClinicalTrials.gov |
| Secondary | The impact of the menstrual cycle on emotional manifestations | 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) | ClinicalTrials.gov |
| Secondary | The impact of the menstrual cycle on cognitive manifestations | 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) | ClinicalTrials.gov |
| Secondary | The impact of the menstrual cycle on behavioral manifestations | 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) | ClinicalTrials.gov |
| Secondary | Subjective differences in real-life emotional experience between ASD, BPD, PMDD and healthy volunteers | 3 months | Premenstrual dysphoric symptoms scores | ClinicalTrials.gov |
| Secondary | Cognitive correlates of emotional dysregulation by phase of the menstrual cycle | 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; | ClinicalTrials.gov |
| Secondary | The concordance between subjective and cognitive measures of emotional dysregulation, assessed in daily life, in ASD, BPD, PMDD and healthy volunteers | 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) | ClinicalTrials.gov |
| Secondary | Evaluate the intensity of dysphoric symptoms during two menstrual cycles | 3 months | Comparison of all these assessments between the groups (autistic women, women with borderline personality disorder, women with PMDD, and control group). | ClinicalTrials.gov |
| Secondary | Understand the impact of these dysphoric symptoms during two menstrual cycles | 3 months | Comparison of all these assessments between the groups (autistic women, women with borderline personality disorder, women with PMDD, and control group). | ClinicalTrials.gov |
| Secondary | The evolution of the emotional experience, assessed in daily life, during two menstrual cycles | 3 months | Comparison of all these assessments between the groups (autistic women, women with borderline personality disorder, women with PMDD, and control group). | ClinicalTrials.gov |
| Secondary | The evolution of cognitive functioning underlying emotional dysregulation, over the course of two menstrual cycles | 3 months | Comparison of all these assessments between the groups (autistic women, women with borderline personality disorder, women with PMDD, and control group). | ClinicalTrials.gov |
| Secondary | The association between subjective and cognitive measures of emotional dysregulation, assessed in consultation, in ASD compared to BPD, PMDD, and healthy volunteers | 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); | ClinicalTrials.gov |
| Secondary | The evolution of self-reported emotional dysregulation assessed in daily life during two menstrual cycles | 3 months | Comparison of all these assessments between the groups (autistic women, women with borderline personality disorder, women with PMDD, and control group). | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 2
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Emotional Stroop Task | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)