Perinatal Thymic DYsregulation: Characterization of Perinatal Mood Episodes

NCT ID: NCT07008183

Last Updated: 2025-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-13

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Perinatal Mental Health

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Participants are assigned prospectively to complete self-questionnaires according to the protocol to characterize perinatal mood episodes.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Usual care

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

Group Type EXPERIMENTAL

self-questionnaires

Intervention Type OTHER

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

Interventions

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self-questionnaires

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Charles Perrens, Bordeaux

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anne-Laure SUTTER-DALLAY, Prof Md PhD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Charles Perrens

Locations

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Centre Hospitalier CHARLES PERRENS

Bordeaux, Nouvelle-Aquitaine, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Anne-Laure SUTTER DALLAY, Prof, MD, PhD

Role: CONTACT

+33 556561782

Helen SAVARIEAU

Role: CONTACT

+33556563556

Facility Contacts

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Helen SAVARIEAU

Role: primary

+33556563556

Marine GALLET, MD

Role: backup

+33 789 416 570

References

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

Reference Type RESULT
PMID: 11570712 (View on PubMed)

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.

Reference Type RESULT
PMID: 7161736 (View on PubMed)

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.

Reference Type RESULT
PMID: 8818366 (View on PubMed)

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.

Reference Type RESULT
PMID: 1995132 (View on PubMed)

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.

Reference Type RESULT
PMID: 16107910 (View on PubMed)

Other Identifiers

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2024-A02708-39

Identifier Type: -

Identifier Source: org_study_id

ID-RCB

Identifier Type: OTHER

Identifier Source: secondary_id

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