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Pregnancy-related neural and hormonal changes associated with depression risk – PlasMa

Pregnancy-related neural and hormonal changes associated with depression risk – PlasMa - PlasMa

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00038312
Enrollment
400
Registered
2025-11-24
Start date
2026-02-16
Completion date
Unknown
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

No specific illness or health issue is being investigated.

Interventions

Group 1: As part of this retrospective observational study, women who have never been pregnant and are planning to become pregnant within the next year will be included to determine the relationship b

Sponsors

Institut für Medizinische Psychologie (Zentrum für Psychosoziale Medizin)
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: a) >=18 years b) sufficient proficiency in German c) planning to become pregnant within the next year d) existing health insurance e) ability to provide consent

Exclusion criteria

Exclusion criteria: a) current depressive episode b) previous pregnancy (including elective and spontaneous abortions) c) Long-term medication that significantly disrupts the production and function of reproductive hormones d) Current medication with antidepressants e) MRI incompatibility f) Known diagnoses that significantly impacts fertility Note: Reproductive medical treatment that was started after the baseline measurement does not lead to exclusion from the study.

Design outcomes

Primary

MeasureTime frame
1. Morphology and connectivity of regions in the brain that have been linked to caregiving behavior and postpartum depressive symptoms in previous studies, e.g., orbitofrontal cortex, striatum, anterior cingulate cortex, and insula, as well as activity in these regions during tasks involving emotion regulation, emotion inhibition, and reward, measured using structural, functional, and diffusion MRI. 2. Concentrations of endocrine parameters (estradiol, estriol, progesterone) and the neuroactive steroid allopregnanolone at five time points (1x before, 3x during, and 1x after pregnancy) 3. Depressive symptoms assessed using Module A of the Structured Clinical Interview for DSM-V (SKID-5, First and Beesdo-Baum, 2019) at the time of study inclusion and three months postpartum, as well as the self-assessment scales Center for Epidemiological Studies – Depression scale (CES-D, Radloff, 1977; Riediger et al., 1998) and Edinburgh Postnatal Depression Scale (EPDS, Bergant et al., 1998; Cox et al., 2014) at all survey points.

Secondary

MeasureTime frame
1. Social and physical environmental conditions during childhood are retrospectively recorded using questionnaires and geocoded data and cover various aspects to enable a detailed characterization of developmental conditions. These include: early stress experiences (Teicher and Parigger, 2015), material deprivation (Guio et al., 2018), perceived social cohesion and neighborhood quality (Araya et al., 2006; Dupuis et al., 2016), perceived social support (Canty-Mitchell & Zimet, 2000), critical life events (Wolfe et al., 2012), urbanity of the residential area, and the extent of green spaces and air pollution within the residential neighborhood (satellite-based). 2. Maternal caregiving behavior is assessed at 3 months postpartum using an interactive play situation. Coding schemes are used to determine the extent of maternal sensitivity, dyadic synchrony, and maternal touch (Censullo et al., 1987; Mantis et al., 2019; Stack et al., 1996).

Countries

Germany

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Apr 4, 2026