Perinatal Mental HealthDYPNCT07008183
Perinatal Thymic DYsregulation: Characterization of Perinatal Mood Episodes
A study testing self-questionnaires in people with Perinatal Mental Health, run by Centre Hospitalier Charles Perrens, Bordeaux at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Perinatal Mental Health
- What is being tested?
- self-questionnaires
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 13 Oct 2025to 31 Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Women who gave birth more than a year ago.
- Participant under psychiatric care
- Participant under court protection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier CHARLES PERRENS
Bordeaux, New Aquitaine, 33076
Helen SAVARIEAU, +33556563556, hsavarieau@ch-perrens.fr
Marine GALLET, MD, +33 789 416 570, galletm@ch-perrens.fr
About this study
Official title: Perinatal Thymic Dysregulation: Characterization of Perinatal Mood Episodes
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
- Being tested
- self-questionnaires
- Keywords
- perinatal mental health, perinatal depression, perinatal bipolar troubles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self-questionnairesOther
Patients who volunteer to take part in the research will complete self-questionnaires before their appointment with the psychiatrist.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | Experimental | The study aims to systematize the evaluation of the various criteria used to characterize mood episodes, and to explore contextual elements. Receives: Other: self-questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day
Detailed description of Multidimensional Assessment of Thymic (MAThyS) scale
Measured: 1 day
Secondary outcomes (3)
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
Measured: 1 day
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
Measured: 1
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
Measured: 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start13 Oct 2025
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Perinatal Mental HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants are assigned prospectively to complete self-questionnaires according to the protocol to characterize perinatal mood episodes.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Charles Perrens, Bordeaux
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Anne-Laure SUTTER-DALLAY, Prof Md PhD, Principal investigator, Centre Hospitalier Charles Perrens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07008183
- Sponsor's protocol ID
- 2024-A02708-39
- Other IDs
- ID-RCB
- Acronym
- DYP
- Status last verified
- Nov 2025
- First submitted
- 6 May 2025
- Last updated
- 1 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 11570712Ballinger 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 7161736Areias 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 8818366Appleby 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 1995132Anderson 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