Depression, PostpartumEPDS-PERENCT06772701
Validation of the French Version of the Edinburgh Postnatal Depression Scale (EPDS) Postnatally in the Father
A study testing Mini International Neuropsychiatric Interview and EPDS book in people with Depression, Postpartum, run by Groupe Hospitalier du Havre at 2 sites in France.
Trial summary
In recent years, fatherhood has changed considerably. Fathers are now more involved during the perinatal period, with their partner but also in caring for the child. Investigators now know that this period is also a source of major psychological upheaval, identity crisis, apprehension and anxiety for men. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Depression, Postpartum
- What is being tested?
- Mini International Neuropsychiatric Interview and EPDS book
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 2 sitesFrance
- Study dates
- 11 Jul 2024to 12 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All fathers whose baby is 10 days old or less
Who cannot join
- People with a poor understanding of spoken or written French
- Minors
- Persons under court protection, guardianship or curatorship
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Enrolling by invitation
Antoine-Béclère hospital AP-HP
Clamart, 92140
- Recruiting
Le Havre hospital - site Jacques Monod
Montivilliers, 76290
PICARD Angélique, 0232734856
Gisèle APTER, Professor - child psychiatry
About this study
In recent years, fatherhood has changed considerably. Fathers are now more involved during the perinatal period, with their partner but also in caring for the child. Investigators now know that this period is also a source of major psychological upheaval, identity crisis, apprehension and anxiety for men. These upheavals can lead to depression that must be detected and treated as early as possible. This is an easy screening to perform using the EPDS (Edinburgh Postnatal Depression Scale). Currently, the EPDS is the most widely used self-questionnaire to assess the risk of depression in women during the perinatal period. Indeed, it is systematically recommended in many countries. It is starting to be used for the same purpose in the perinatal period in men, although the scale has not been validated in a representative sample of men in the pre- or post-natal period.
The main objective is to validate the use of the EPDS scale as a screening tool for postnatal depression in a population of French fathers.
They complete the PH-Q9, EPDS and socio-demographic questionnaires online at inclusion and 6 to 8 weeks after the birth of their child. Fathers included at the maternity ward also too Mini International Neuropsychiatric Interview (MINI) at inclusion.
Read the detailed description
Fathers complete the PH-Q9, EPDS and socio-demographic questionnaires online at inclusion and 6 to 8 weeks after the birth of their child. Fathers included at the maternity ward also too Mini International Neuropsychiatric Interview (MINI) at inclusion.
- Conditions
- Depression, Postpartum
- Being tested
- Mini International Neuropsychiatric Interview, EPDS book
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mini International Neuropsychiatric InterviewDiagnostic test
Fathers have Mini International Neuropsychiatric Interview, the standard diagnostic tool for post-natal depression
EPDS bookOther
PH-Q9, EPDS and socio-demographic questionnaires are completed online at inclusion and 6 to 8 weeks after the birth of child.
| Study group | Role | What they receive |
|---|---|---|
| Fathers included at the maternity hospital or through their wife | Active comparator | At inclusion, fathers included at the maternity hospital or through their wife take the Mini International Neuropsychiatric Interview and complete the EPDS book (PH-Q9, EPDS and socio-demographic questionnaire). 6 to 8 weeks after the birth of their child, they complete only EPDS book. Receives: Diagnostic Test: Mini International Neuropsychiatric Interview; Other: EPDS book |
| fathers includes through the awareness campaign | Experimental | At inclusion, fathers included through the awareness campaign have only the EPDS book (PH-Q9, EPDS and socio-demographic questionnaire) at inclusion. 6 to 8 weeks after the birth of their child, they complete the same EPDS book. Receives: Other: EPDS book |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini International Neuropsychiatric Interview
This short structured clinical interview is used to diagnose psychiatric disorders and is currently the gold standard for diagnosing depression.
Measured: at inclusion
Secondary outcomes (1)
socio-demographic questionnaire
Socio-demographic data will be a secondary evaluation criterion. It will be used to study risk and protective factors, both those already known in the literature and those that have been little studied, and to identify profiles that are more at risk, with a view to taking preventive action in the field.
Measured: at inclusion and 6 to 8 weeks after the birth of their child
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start11 Jul 2024
- Primary completion12 Jan 2027 (estimated)
- Study completion12 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression, PostpartumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Fathers included at the maternity hospital or through the mother take the Mini International Neuropsychiatric Interview and complete the PH-Q9, EPDS and socio-demographic questionnaires. Fathers included through the awareness campaign have only the PH-Q9, EPDS and socio-demographic questionnaires.
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier du Havre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06772701
- Sponsor's protocol ID
- 2024-A00242-45
- Acronym
- EPDS-PERE
- Status last verified
- Jan 2026
- First submitted
- 9 Jan 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the French Version of the Edinburgh Postnatal Depression Scale (EPDS) Postnatally in the Father
- ClinicalTrials.gov ID
- NCT06772701
- Acronym / sponsor ID
- EPDS-PERE / 2024-A00242-45
- Conditions
- Depression, Postpartum
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Groupe Hospitalier du HavreUniversity, hospital or other
- Study start
- 11 Jul 2024 (actual)
- Primary completion
- 12 Jan 2027 (estimated)
- Study completion
- 12 Mar 2027 (estimated)
- First posted
- 13 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In recent years, fatherhood has changed considerably. Fathers are now more involved during the perinatal period, with their partner but also in caring for the child. Investigators now know that this period is also a source of major psychological upheaval, identity crisis, apprehension and anxiety for men. These upheavals can lead to depression that must be detected and treated as early as possible. This is an easy screening to perform using the EPDS (Edinburgh Postnatal Depression Scale). Currently, the EPDS is the most widely used self-questionnaire to assess the risk of depression in women during the perinatal period. Indeed, it is systematically recommended in many countries. It is starting to be used for the same purpose in the perinatal period in men, although the scale has not been validated in a representative sample of men in the pre- or post-natal period.
The main objective is to validate the use of the EPDS scale as a screening tool for postnatal depression in a population of French fathers.
They complete the PH-Q9, EPDS and socio-demographic questionnaires online at inclusion and 6 to 8 weeks after the birth of their child. Fathers included at the maternity ward also too Mini International Neuropsychiatric Interview (MINI) at inclusion.
Detailed description
Fathers complete the PH-Q9, EPDS and socio-demographic questionnaires online at inclusion and 6 to 8 weeks after the birth of their child. Fathers included at the maternity ward also too Mini International Neuropsychiatric Interview (MINI) at inclusion.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Fathers included at the maternity hospital or through the mother take the Mini International Neuropsychiatric Interview and complete the PH-Q9, EPDS and socio-demographic questionnaires. Fathers included through the awareness campaign have only the PH-Q9, EPDS and socio-demographic questionnaires.
| Arm | Type | Receives |
|---|---|---|
| Fathers included at the maternity hospital or through their wife | Active comparator | Diagnostic Test: Mini International Neuropsychiatric Interview, Other: EPDS bookAt inclusion, fathers included at the maternity hospital or through their wife take the Mini International Neuropsychiatric Interview and complete the EPDS book (PH-Q9, EPDS and socio-demographic questionnaire). 6 to 8 weeks after the birth of their child, they complete only EPDS book. |
| fathers includes through the awareness campaign | Experimental | Other: EPDS bookAt inclusion, fathers included through the awareness campaign have only the EPDS book (PH-Q9, EPDS and socio-demographic questionnaire) at inclusion. 6 to 8 weeks after the birth of their child, they complete the same EPDS book. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All fathers whose baby is 10 days old or less
Key exclusion criteria (3 listed)
- People with a poor understanding of spoken or written French
- Minors
- Persons under court protection, guardianship or curatorship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mini International Neuropsychiatric InterviewFathers have Mini International Neuropsychiatric Interview, the standard diagnostic tool for post-natal depression | Diagnostic test | Fathers included at the maternity hospital or through their wife |
| EPDS bookPH-Q9, EPDS and socio-demographic questionnaires are completed online at inclusion and 6 to 8 weeks after the birth of child. | Other | Fathers included at the maternity hospital or through their wife, fathers includes through the awareness campaign |
Primary outcome
Mini International Neuropsychiatric Interview
Time frame: at inclusion
This short structured clinical interview is used to diagnose psychiatric disorders and is currently the gold standard for diagnosing depression.
1 secondary outcome
socio-demographic questionnaire
Time frame: at inclusion and 6 to 8 weeks after the birth of their child
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mini International Neuropsychiatric Interview and EPDS book in people with Depression, Postpartum, run by Groupe Hospitalier du Havre at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Angélique PICARD, project coordinator (+33232734856, angelique.picard@ch-havre.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mini International Neuropsychiatric Interview (time frame: at inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.