跳至主要内容
临床试验/NCT07008183
NCT07008183招募中不适用

Perinatal Thymic Dysregulation: Characterization of Perinatal Mood Episodes

Centre Hospitalier Charles Perrens, Bordeaux2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年10月13日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
2
主要终点
Detailed description of the Edinburg Postnatal (EPDS) scale

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

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

结局指标

主要结局

Detailed description of the Edinburg Postnatal (EPDS) scale

时间窗: 1 day

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

Detailed description of Multidimensional Assessment of Thymic (MAThyS) scale

时间窗: 1 day

次要结局

  • 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)

研究者

发起方
Centre Hospitalier Charles Perrens, Bordeaux
申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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