Perinatal Thymic DYsregulation: Characterization of Perinatal Mood Episodes

NCT07008183 | Recruiting

• 2 other identifiers: 2024-A02708-39ID-RCB
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Perinatal Mental Health

Keywords

perinatal mental health; perinatal depression; perinatal bipolar troubles

Outcome Measures

Primary Outcomes (2)

• Detailed description of the Edinburg Postnatal (EPDS) scale

  A sensitivity analysis will be carried out on the group of patients with an EPDS score greater than 12, and a comparison between these patients and patients with an EPDS score equal to or less than 12 will also be carried out

  1 day

• Detailed description of Multidimensional Assessment of Thymic (MAThyS) scale

  1 day

Secondary Outcomes (3)

• Association of the risk factors Perceived Stress Scale (PSS) will be assessed by self-report

  1 day

• Association of the risk factors Medical Outcomes Study -Social Support Survey (MOS-SSS) will be assessed by self-report

  1

• Association of the risk factors Perceived Professional Social Support (QSSP-P) will be assessed by self-report

  1

Study Arms (1)

Usual care

EXPERIMENTAL

The study aims to systematize the evaluation of the various criteria used to characterize mood episodes, and to explore contextual elements.

Other: self-questionnaires

Interventions

self-questionnaires OTHER

Patients who volunteer to take part in the research will complete self-questionnaires before their appointment with the psychiatrist.

Usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Charles Perrens, Bordeaux: lead

Study Sites (1)

Centre Hospitalier CHARLES PERRENS

Bordeaux, Nouvelle-Aquitaine, 33076, France

RECRUITING

Related Publications (5)

• Beck CT. Predictors of postpartum depression: an update. Nurs Res. 2001 Sep-Oct;50(5):275-85. doi: 10.1097/00006199-200109000-00004.

  PMID: 11570712 RESULT

• 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.

  PMID: 7161736 RESULT

• 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.

  PMID: 8818366 RESULT

• 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.

  PMID: 1995132 RESULT

• 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.

  PMID: 16107910 RESULT

Study Officials

• Anne-Laure SUTTER-DALLAY, Prof Md PhD

  Centre Hospitalier Charles Perrens

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne-Laure SUTTER DALLAY, Prof, MD, PhD

CONTACT

+33 556561782; alsutter@ch-perrens.fr

Helen SAVARIEAU

CONTACT

+33556563556; hsavarieau@ch-perrens.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Participants are assigned prospectively to complete self-questionnaires according to the protocol to characterize perinatal mood episodes.

Study Record Dates

• First Submitted: May 6, 2025
• First Posted: June 6, 2025
• Study Start: October 13, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 1, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)