An interventional study of Multimodal MRI and EEG-ECG/PPG recordings and Biological sampling in Depression in Pregnancy, Major Depressive Disorder and Pregnancy, sponsored by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico. Recruiting at 3 sites in 3 countries. Open to participants aged Up to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Not applicable, Interventional, and Basic science
Among 164 studies in Depressive Disorder, Major with a site in Germany — 26 open to participants now, 27 under way, 5 of them phase 3. Depressive Disorder, Major · Germany.
Among the 164 studies in Depressive Disorder, Major with a site in Germany, this one is the 25th largest by planned enrollment of the 150 interventional ones that give a count, is one of 7 that started in 2026, is one of 53 with no phase, reaches primary completion later than 13 of the 26 other live ones, and was the 164th registered.
3,041 studies on the registry are indexed under Depressive Disorder, Major; 588 are open to participants now.
Browse Depressive Disorder, Major studies →26 of the 164 studies in Depressive Disorder, Major with a site in Germany are open now. Recruiting first, the newest first:
Eli Lilly and Company · Sites in Germany, United States, Australia and 12 more countries
Ages 18–75
University of Regensburg · Sites in Germany
Ages 18–70
Eli Lilly and Company · Sites in Germany, United States, Australia and 12 more countries
Ages 18–75
Cybin IRL Limited · Sites in Germany, United States, Australia and 5 more countries
Ages 18–85
Philipps University Marburg · Sites in Germany
Ages 18–80
A study can be open while its sites in Germany have not opened yet or have stopped. Only those recruiting at a site in Germany →
Of the 410 Depressive Disorder, Major studies recruiting now, 92 (22%) set no upper age limit and 292 (71%) stop at 75 or younger; 54 take children under 18; 98 take healthy volunteers.
This study: Up to 45 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
164 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 11 · Phase 2 29 · Phase 3 51 · Phase 4 10
First in 1998; this study’s year is marked. 7 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 720 is above the median of 79 across 2,530 interventional studies indexed under Depressive Disorder, Major.
Median enrollment 176 across the 150 interventional studies, 104 across the 13 observational. Of the 124 that completed or were terminated, 43 (35%) have results posted.
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80 of 164 have an industry lead sponsor. The 10 most frequent:
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico is the lead sponsor of 234 studies on the registry; 78 are open to participants now.
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico has 3 studies filed under Depressive Disorder, Major — fewer than ten, so there is no comparison to draw.
10 of the studies in Depressive Disorder, Major with a site in Germany that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07076407Phase 3Xenon Pharmaceuticals Inc.A Randomized Study of Azetukalner Versus Placebo in Major Depressive Disorder (X-NOVA3) | 2027-05 |
| NCT06793397Phase 3Cybin IRL LimitedA Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder | 2027-06-07 |
| NCT06389175University of BonnNon-invasive Vagus Nerve Stimulation as a Tool to Modulate Stomach-Brain Coupling in Depression | 2026-12 |
| NCT07197138Max-Planck-Institute of PsychiatryIMPACT-D+: Immune-Modulating and Psychometric Effects of Accelerated TMS in Depression Plus Comorbid Post-COVID-19 Condition | 2027-01 |
| NCT07065240Seaport TherapeuticsA Study to Evaluate the Efficacy and Safety of SPT-300 (GlyphAllo) in Participants With Major Depressive Disorder, With or Without Anxious Distress (BUOY-1 Study) | 2027-03 |
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Among the 164 studies in Depressive Disorder, Major with a site in Germany, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The goal of this study is to learn how depression during pregnancy is linked to changes in the brain and body of the mother and to the development of the baby, in pregnant women with major depressive disorder (MDD) and pregnant women without depression.
The main questions it aims to answer are:
Pregnant women will be screened within the 20th week of pregnancy and assigned to the MDD group or to the control group based on a structured clinical interview. They will not receive any study drug: women with depression will receive the usual care recommended by clinical guidelines.
Participants will:
Their newborns will have a neurological and visual examination, a brain MRI and an EEG-ECG or PPG recording after birth, and a developmental assessment (Bayley Scales) at 6 months.
BRAWO is a non-pharmacological, international, multicenter, non-profit study conducted in Italy (Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, coordinating center), Spain (Institute of Biomedicine of Seville, IBiS) and Germany (Philipps University Marburg). It implements Work Package 3 of the BRAWO research project, funded under the ERA-NET NEURON Joint Transnational Call 2024 "Bidirectional brain-body interactions".
The study is classified as interventional because it includes procedures that are not part of standard clinical care (maternal, fetal and neonatal MRI, EEG-ECG/PPG recordings, biological sampling). These procedures are non-invasive or minimally invasive. No investigational medicinal product is tested; women with MDD receive standard care, which may include SSRI antidepressants.
Groups:
Visits: V0 screening (within 20 gestational weeks, GW), V1 (by 22 GW), V2 (26 GW), V3 (32 GW), V4 (birth), V5 (1 month postpartum), V6 (6 months postpartum).
Maternal clinical assessments include clinician-rated scales (Hamilton Depression Rating Scale, Hamilton Anxiety Rating Scale, Global Assessment of Functioning) and self-rated questionnaires (EPDS, STAI Y1-2, SCL-90-R, CES-D); bonding, couple and family scales (MPAS, PBQ, ECR-R, RQI, DAS, FES, PSI-SF) are administered at 1 and 6 months postpartum.
Biological samples: maternal plasma at V1, V2 and V3, umbilical venous cord blood at birth, and placental tissue (elective cesarean deliveries, about 10 participants per group, Milan only). Proteomic analyses (LC-MS/MS) are centralized in Milan; placental samples also undergo RNA sequencing and histological analyses. With specific consent, residual samples are stored in the Policlinico biobank.
Neuroimaging and electrophysiology: maternal multimodal MRI (structural, diffusion, task and resting-state functional MRI) with simultaneous EEG-ECG (Milan) or ECG/PPG (Seville, Marburg); fetal MRI; neonatal MRI and EEG-ECG/PPG at 40+0 to 43+6 weeks of gestational age. Data are harmonized across sites (e.g., ComBat).
Sample size: a screening target of 600 pregnant women was calculated to estimate MDD prevalence (expected 15%, precision ±3.42%, 95% confidence level, 30% dropout). At least 60 women per group completing follow-up to 6 months postpartum provide >90% power to detect hippocampal volume differences (two-sample t-test, alpha 0.05). In total, 600 pregnant women and 120 newborns are expected to be enrolled. An interim analysis of dropout rate and data quality is planned at about half of enrollment.
Pre-collected data from a previous study at the coordinating center (MINI protocol) and publicly available data from the developing Human Connectome Project (dHCP) will be used to train multivariate, machine learning and dynamical systems models, which will be tested on BRAWO data to predict maternal and infant outcomes at 6 months.
Data are collected in REDCap and imaging data in XNAT.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Pregnant women with major depressive disorder (Group 1):
Pregnant women without depression (Group 2):
Placental tissue sampling (Milan only, Groups 1 and 2):
Newborns:
Exclusion Criteria:
Pregnant women (Groups 1 and 2):
Newborns:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Pregnant women aged 18-45 years diagnosed with major depressive disorder (SCID-5-CV) at screening (within 20 gestational weeks), followed until 6 months postpartum, and their newborns. Participants receive standard clinical care for depression, which may include SSRI antidepressants; no study drug is administered.
Diagnostic Test: Multimodal MRI and EEG-ECG/PPG recordings · Procedure: Biological sampling · Other: Clinical and neurodevelopmental assessments
Pregnant women aged 18-45 years without current or past psychiatric disorders and without family history of psychiatric disorders (SCID-5-CV and FIGS), followed until 6 months postpartum, and their newborns.
Diagnostic Test: Multimodal MRI and EEG-ECG/PPG recordings · Procedure: Biological sampling · Other: Clinical and neurodevelopmental assessments
Study-specific, non-invasive acquisitions: maternal brain MRI (structural, diffusion, task and resting-state fMRI) with simultaneous EEG-ECG (Milan) or ECG/PPG (Seville, Marburg) by 22 gestational weeks; fetal MRI by 22 gestational weeks; fetal ultrasound at 22, 26 and 32 gestational weeks; neonatal brain MRI and polygraphic EEG-ECG (Milan, Marburg) or MRI with PPG (Seville, Marburg) at 40+0 to 43+6 weeks of gestational age, during spontaneous sleep without sedation.
Maternal peripheral blood sampling at 22, 26 and 32 gestational weeks (plasma aliquots stored at -80 °C); umbilical venous cord blood sampling at birth; placental tissue sampling in a subgroup of about 10 participants per group with elective cesarean delivery (Milan only). Proteomic analysis by LC-MS/MS; placental RNA sequencing and histology. Residual samples stored in the Policlinico biobank with specific consent.
Maternal clinician-rated scales (HDRS, HARS, GAF) and self-rated questionnaires (EPDS, STAI Y1-2, SCL-90-R, CES-D) from screening to 6 months postpartum; bonding, couple and family scales (MPAS, PBQ, ECR-R, RQI, DAS, FES, PSI-SF) at 1 and 6 months postpartum; neonatal Hammersmith Neonatal Neurological Examination and visual function assessment after birth; Bayley Scales of Infant and Toddler Development, Third Edition at 6 months.
Prevalence of Major Depressive Disorder Among Screened Pregnant Women
Percentage of pregnant women screened within 20 gestational weeks who meet DSM-5 criteria for major depressive disorder according to the Structured Clinical Interview for DSM-5, Clinical Version (SCID-5-CV). The prevalence will be reported with its 95% confidence interval.
Time frame: At screening (within 20 gestational weeks)
Left Hippocampal Volume
Left hippocampal volume, expressed in milliliters (mL), estimated from 3D T1-weighted brain MRI processed with CAT12, compared between pregnant women with major depressive disorder and pregnant women without depression.
Time frame: At Visit 1 (by 22 gestational weeks)
Right Hippocampal Volume
Right hippocampal volume, expressed in milliliters (mL), estimated from 3D T1-weighted brain MRI processed with CAT12, compared between pregnant women with major depressive disorder and pregnant women without depression.
Time frame: At Visit 1 (by 22 gestational weeks)
Hamilton Depression Rating Scale (HDRS) Total Score at 6 Months Postpartum
Maternal depressive symptom severity assessed with the clinician-administered Hamilton Depression Rating Scale (HDRS). Higher scores indicate more severe depression.
Time frame: 6 months postpartum
Number of Depressive Relapses After Birth
Number of depressive relapses per participant in the 6 months after birth, confirmed with the SCID-5-CV by a psychiatrist or psychologist.
Time frame: From birth to 6 months postpartum
Bayley-III Cognitive Composite Score
Infant cognitive development assessed with the Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III), cognitive scale. Composite scores have a mean of 100 and a standard deviation of 15; higher scores indicate better development.
Time frame: 6 months of age
Bayley-III Language Composite Score
Infant language development (receptive and expressive) assessed with the Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III), language scale. Composite scores have a mean of 100 and a standard deviation of 15; higher scores indicate better development.
Time frame: 6 months of age
Bayley-III Motor Composite Score
Infant motor development (fine and gross) assessed with the Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III), motor scale. Composite scores have a mean of 100 and a standard deviation of 15; higher scores indicate better development.
Time frame: 6 months of age
Number of Participants With Preterm Birth
Number of participants delivering at 28 weeks or more but before 37 completed weeks of gestation.
Time frame: At birth
Number of Newborns With Low Birth Weight
Number of newborns with birth weight below 2500 grams.
Time frame: At birth
Number of Newborns Small for Gestational Age
Number of newborns classified as small for gestational age (SGA) based on birth weight for gestational age.
Time frame: At birth
Number of Newborns With Apgar Score Below 7
Number of newborns with an Apgar score below 7 at 1 and at 5 minutes after delivery. The Apgar score ranges from 0 to 10, with lower scores indicating poorer condition at birth.
Time frame: 1 and 5 minutes after birth
Hammersmith Neonatal Neurological Examination (HNNE) Total Score
Neonatal neurological maturity assessed with the Hammersmith Neonatal Neurological Examination (posture, tone, reflexes, movements, abnormal signs and behavior). Higher scores indicate more optimal neurological status.
Time frame: Within the first days after birth
Edinburgh Postnatal Depression Scale (EPDS) Total Score
Maternal self-reported depressive symptoms assessed with the 10-item Edinburgh Postnatal Depression Scale. Total score ranges from 0 to 30; higher scores indicate more severe symptoms.
Time frame: 1 month and 6 months postpartum
Plan to share: Undecided — Individual participant data sharing will be decided by the BRAWO consortium according to the Consortium Agreement and applicable data protection regulations (GDPR).
No publications or documents are linked to this record.
Started Apr 2026 (actual). Primary completion is estimated for Oct 2027, 18 months after the start.
Of 647 non-industry interventional studies with no phase under Depressive Disorder, Major, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 55. This study's planned 18 months is below that.
Counting every sponsor, half of 687 studies reached it within 33 months; a quarter within 17 and three quarters within 55.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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