Phase 4 Depression and Anxiety Trial, Recruiting NCT06833788 Sponsor: Assistance Publique - Hôpitaux de Paris Condition: Depression and Anxiety
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Phase 4 Depression and Anxiety Trial, Recruiting

NCT06833788
Recruiting Phase 4

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People aged 18 or older
  • People who have had a caesarean delivery (planned or emergency)
  • People who gave birth at 32 weeks of pregnancy or later
  • People whose haemoglobin (a measure of red blood cells) was measured within 72 hours after birth and fell within a specific moderate range — not too low, not normal (confirm with trial site for exact values)
  • People whose iron stores (measured by ferritin level or transferrin saturation — two types of iron blood tests) are below a certain threshold, tested after the haemoglobin measurement
  • People who scored below 11 on a postnatal mood questionnaire (called the EPDS) shortly after birth, and answered "never" to question 10 of that questionnaire
  • People who have signed a consent form agreeing to take part
  • People staying in the postnatal maternity ward
  • People covered by French national social security, including AME (a form of French health coverage)

Who may not be able to join:

  • People whose baby was stillborn or died shortly after birth
  • People whose recorded body weight (measured late in pregnancy or after birth) was below 35kg or above 100kg
  • People with Biermer disease (a condition affecting vitamin B12 absorption)
  • People with haemochromatosis (a condition causing the body to store too much iron)
  • People with homozygous sickle cell disease or thalassaemia (inherited blood disorders)
  • People who were taking iron supplements regularly before pregnancy (not as part of pregnancy care)
  • People with a known allergy or sensitivity to the iron treatments being studied (whether given by injection or by mouth)
  • People for whom the iron treatments being studied (injectable or oral iron) are medically unsuitable
  • People with severe asthma requiring daily ongoing medication
  • People with a known serious kidney or liver condition
  • People with an active infection at the time of joining
  • People with a diagnosis of schizophrenia, or whose physical or intellectual condition would make it difficult to reliably complete self-assessment questionnaires
  • People currently receiving medication or electroconvulsive therapy (ECT) for depression or bipolar disorder
  • People already participating in another clinical trial that could affect haemoglobin levels at 2 months after birth, affect EPDS mood scores at 2 or 6 months after birth, or that involves a treatment with a risk of serious allergic reaction given during the postnatal hospital stay
  • People who do not have a sufficient understanding of the French language
  • People under legal guardianship or a formal protection order (curatorship or tutorship)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 26 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: Marie-Pierre BONNET, MD, PhD, Assistance Publique - Hôpitaux de Paris

Phone: (+) 33 1 71 73 89 56

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 4
Registry
ClinicalTrials.gov
Start date
22 October 2025
Est. completion
22 June 2028

Where this trial is recruiting

🇫🇷 France

Primary endpoints

Prevalence of PostPartum Depression (PPD) symptoms defined by an Edinburg Postpartum Depression Scale (EPDS) score ≥ 11

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov