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RecruitingNCT07008183DYPUpdated Dec 1, 2025

Perinatal Thymic DYsregulation: Characterization of Perinatal Mood Episodes

An interventional study of self-questionnaires in Perinatal Mental Health, sponsored by Centre Hospitalier Charles Perrens, Bordeaux. Recruiting at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-01.

Sponsored by Centre Hospitalier Charles Perrens, Bordeaux · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Started Oct 2025; still recruiting 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Perinatal Mental Health

Keywords

  • perinatal mental health
  • perinatal depression
  • perinatal bipolar troubles
03

In context

Lead sponsor

Centre Hospitalier Charles Perrens, Bordeaux is the lead sponsor of 19 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Women who gave birth more than a year ago.
  • Participant under psychiatric care
  • Participant under court protection
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    Usual care

    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

  • Otherself-questionnaires

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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 1 day

  2. Detailed description of Multidimensional Assessment of Thymic (MAThyS) scale

    Time frame: 1 day

Secondary outcomes

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

    the level of perceived stress by self report score\>=14 characterize a high level of perceived stress

    Time frame: 1 day

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

    the level of perceived social support by self-report scale scores can range from 19 to 95, with a median score of 57

    Time frame: 1

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

    the level of perceived social support in the professional by self-report. scale scores pcan range from 12 to 120, with a median score of 66

    Time frame: 1

07

Study locations

1 of 1 sites recruiting
  • Centre Hospitalier CHARLES PERRENS
    Bordeaux, New Aquitaine 33076, France
    Recruiting
08

References and documents

Publications

  • Beck CT. Predictors of postpartum depression: an update. Nurs Res. 2001 Sep-Oct;50(5):275-85. doi: 10.1097/00006199-200109000-00004. PubMed 11570712 ↗
  • 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. PubMed 7161736 ↗
  • 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. PubMed 8818366 ↗
  • 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. PubMed 1995132 ↗
  • 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. PubMed 16107910 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 1, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07008183
Lead sponsor
Centre Hospitalier Charles Perrens, Bordeaux
Responsible party
Sponsor
First posted
Jun 6, 2025
Start date
Oct 13, 2025
Primary completion
Jul 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Dec 1, 2025

Study contacts

Anne-Laure SUTTER DALLAY, Prof, MD, PhD
Contact
alsutter@ch-perrens.fr
+33 556561782
Helen SAVARIEAU
Contact
hsavarieau@ch-perrens.fr
+33556563556
Anne-Laure SUTTER-DALLAY, Prof Md PhD
principal investigator · Centre Hospitalier Charles Perrens

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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