Clinical trial NCT07008183: Perinatal Thymic DYsregulation: Characterization of Perinatal Mood Episodes
Official title: Perinatal Thymic Dysregulation: Characterization of Perinatal Mood Episodes
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Perinatal Mental Health
Keywords: perinatal mental health
perinatal depression
perinatal bipolar troubles
Lead sponsor: Centre Hospitalier Charles Perrens, Bordeaux
Sponsor class: OTHER_GOV
First posted: 2025-06-06
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Participants are assigned prospectively to complete self-questionnaires according to the protocol to characterize perinatal mood episodes.
Primary purpose: DIAGNOSTIC

Brief summary: The perinatal period is recognized as a time of heightened psychological vulnerability. This research aims to improve the diagnosis and therapeutic management of mood episodes occurring during this time. It is integrated into routine clinical care and seeks to standardize the evaluation of criteria used to characterize mood episodes, while also exploring relevant contextual factors.

Traditionally, clinical attention has focused on postnatal depression; however, increasing evidence highlights the presence of hypomanic symptoms-such as distractibility, reduced need for sleep, tachypsychia, and irritability-during the postpartum period. These symptoms may coexist with depressive features, resulting in complex clinical presentations that are often difficult to recognize and manage. Consequently, many cases go undiagnosed and untreated.

Current research has largely concentrated on depressive episodes (perinatal depression), with less emphasis on manic, hypomanic, or mixed episodes indicative of bipolar disorder. A systematic evaluation of hypomanic symptoms occurring alongside depressive symptoms in the postpartum period could refine clinical diagnosis and support more targeted and effective therapeutic interventions.


Eligibility criteria: Inclusion Criteria:

* Women over 18 years old
* Pregnant or having given birth less than a year ago
* First psychiatric consultation for the pregnancy concerned.
* Good command of the French language.
* Participant affiliated to the social security system
* Participant who has given her consent to take part in the study.

Exclusion Criteria:

* Women who gave birth more than a year ago.
* Participant under psychiatric care
* Participant under court protection

Primary outcomes:
measure: Detailed description of the Edinburg Postnatal (EPDS) scale
timeFrame: 1 day
measure: Detailed description of Multidimensional Assessment of Thymic (MAThyS) scale
timeFrame: 1 day
Secondary outcomes:
measure: Association of the risk factors Perceived Stress Scale (PSS) will be assessed by self-report
timeFrame: 1 day
measure: Association of the risk factors Medical Outcomes Study -Social Support Survey (MOS-SSS) will be assessed by self-report
timeFrame: 1
measure: Association of the risk factors Perceived Professional Social Support (QSSP-P) will be assessed by self-report
timeFrame: 1
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Centre Hospitalier CHARLES PERRENS
state: Nouvelle-Aquitaine
Study officials:
affiliation: Centre Hospitalier Charles Perrens
name: Anne-Laure SUTTER-DALLAY, Prof Md PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Beck CT. Predictors of postpartum depression: an update. Nurs Res. 2001 Sep-Oct;50(5):275-85. doi: 10.1097/00006199-200109000-00004.
citation: Ballinger CB. Emotional disturbance during pregnancy and following delivery. J Psychosom Res. 1982;26(6):629-34. doi: 10.1016/0022-3999(82)90079-4.
citation: Areias ME, Kumar R, Barros H, Figueiredo E. Correlates of postnatal depression in mothers and fathers. Br J Psychiatry. 1996 Jul;169(1):36-41. doi: 10.1192/bjp.169.1.36.
citation: Appleby L. Suicide during pregnancy and in the first postnatal year. BMJ. 1991 Jan 19;302(6769):137-40. doi: 10.1136/bmj.302.6769.137.
citation: Anderson D, Bilodeau B, Deshaies G, Gilbert M, Jobin J. [French-Canadian validation of the MOS Social Support Survey]. Can J Cardiol. 2005 Aug;21(10):867-73. French.