Perinatal Thymic DYsregulation: Characterization of Perinatal Mood Episodes

Official title

Perinatal Thymic Dysregulation: Characterization of Perinatal Mood Episodes

Overview

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.

Interventions

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

Primary outcome measures

• Detailed description of the Edinburg Postnatal (EPDS) scale [Time frame: 1 day]
• Detailed description of Multidimensional Assessment of Thymic (MAThyS) scale [Time frame: 1 day]

Secondary outcome measures (3)

• Association of the risk factors Perceived Stress Scale (PSS) will be assessed by self-report [Time frame: 1 day]
• Association of the risk factors Medical Outcomes Study -Social Support Survey (MOS-SSS) will be assessed by self-report [Time frame: 1]
• Association of the risk factors Perceived Professional Social Support (QSSP-P) will be assessed by self-report [Time frame: 1]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Diagnostic

Study locations

France · 1 center

• Centre Hospitalier CHARLES PERRENS — Bordeaux

Publications

• 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
• 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
• 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
• 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
• 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

Identifiers

NCT: NCT07008183 · 2024-A02708-39 · ID-RCB

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗