Depression, PostpartumsereneNCT03088319
Post-natal Depression and Chronic Stress
An observational study of Depression, Postpartum, run by Institut de Recherche Biomedicale des Armees at 1 site in France.
Trial summary
The risk of emergence of a post natal depression is based on an interaction between a maternal psychic vulnerability and a chronic environmental context of stress. The PND appears as a relevant model for studying the mechanisms of chronic stress and vulnerability to psychological pathologies. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Depression, Postpartum
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 11 Apr 2017to 11 Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: WOMEN DURING EARLY PREGNANCY
Who may be able to join
- Physiological pregnancy
- Follow-up of pregnancy in a participating maternity
- Female over 18 years
- Affiliated to a social security scheme
Who cannot join
- Multiple pregnancy
- Psychiatric, neurological, or endocrine or autoimmune diseases
- Hormonal or psychotropic treatments
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Chronic Stress Protection for Post-natal Depression Prevention: An Exploratory Study
The risk of emergence of a post natal depression is based on an interaction between a maternal psychic vulnerability and a chronic environmental context of stress. The PND appears as a relevant model for studying the mechanisms of chronic stress and vulnerability to psychological pathologies.
This study aim to follow a cohort of pregnant women to determine the predictive psychobiological factors of the emergence of postnatal depression
Read the detailed description
The prevalence of postnatal depression is high in civilian settings (20%). In mechanistic terms, the risk of emergence of a post natal depression is based on an interaction between a maternal psychic vulnerability and a chronic environmental context of stress. The post natal depression appears as a relevant model for studying the mechanisms of chronic stress and vulnerability to psychological pathologies.
- On the one hand, the repetition of stressors during pregnancy corresponds to a natural chronic stress model of several months and thus allows to study the biological cost of responses to repeated stresses, and the adaptive mechanisms leading to From functional drift to psychic dysfunction.
- On the other hand, isolated vulnerability factors characterize a mirroring psychological profile of a Mindfulness type of functioning. Mindfulness or full consciousness has been described as a state of consciousness which results from intentionally, at the present moment, without judging the experience that unfolds moment by moment. This psychological resource has been associated with resilient or even resilient psychic functioning.
This study aim to follow a cohort of pregnant women from the first trimester of pregnancies to 2 months after the delivery to determine the predictive psychobiological factors of the emergence of postnatal depression
- Conditions
- Depression, Postpartum
- Keywords
- postnatal depression stress mindfulness allostatic load
- Medical subject headings
- Depression, Postpartum
What is being measured
The primary outcome is the main question the study is designed to answer.
post natal depression
change in Edimbourg Post-Partum Depression scale at two months after labour delivery
Measured: baseline at three 3 months of pregnancy and two months after labour delivery
Secondary outcomes (1)
allostatic load as a composite index including blood GABA, BDNF and 8iso-Prostaglandins and capillary cortisol + heart rate variability index
change in allostatic load two months after labour delivery
Measured: baseline at three 3 months of pregnancy and two months after labour delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2017
- Study start11 Apr 2017
- Primary completion11 Oct 2019
- Study completion11 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Recherche Biomedicale des Armees
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Marion Trousselard, Institut de Recherche Biomedicale des Armees
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03088319
- Sponsor's protocol ID
- 2016-A00887-44
- Acronym
- serene
- Status last verified
- Aug 2018
- First submitted
- 11 Mar 2017
- Last updated
- 12 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tharwat D, Trousselard M, Bales M, Sutter-Dallay AL, Fromage D, Spitz E, Dallay D, Harvey T, Welter E, Coatleven F, Cherier L, Teissedre F, Pouly JL, Dutheil F, Duffaud AM. Chronic Stress protection for postnatal dEpREssioN prEvention (SERENE): a protocol for an exploratory study. BMJ Open. 2018 May 3;8(5):e018317. doi: 10.1136/bmjopen-2017-018317.
PubMed 29724735
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Stress Protection for Post-natal Depression Prevention: An Exploratory Study
- ClinicalTrials.gov ID
- NCT03088319
- Acronym / sponsor ID
- serene / 2016-A00887-44
- Conditions
- Depression, Postpartum
- Keywords
- postnatal depression stress mindfulness allostatic load
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Institut de Recherche Biomedicale des ArmeesOther government
- Study start
- 11 Apr 2017 (actual)
- Primary completion
- 11 Oct 2019 (actual)
- Study completion
- 11 Oct 2019 (actual)
- First posted
- 23 Mar 2017 (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.
The risk of emergence of a post natal depression is based on an interaction between a maternal psychic vulnerability and a chronic environmental context of stress. The PND appears as a relevant model for studying the mechanisms of chronic stress and vulnerability to psychological pathologies.
This study aim to follow a cohort of pregnant women to determine the predictive psychobiological factors of the emergence of postnatal depression
Detailed description
The prevalence of postnatal depression is high in civilian settings (20%). In mechanistic terms, the risk of emergence of a post natal depression is based on an interaction between a maternal psychic vulnerability and a chronic environmental context of stress. The post natal depression appears as a relevant model for studying the mechanisms of chronic stress and vulnerability to psychological pathologies.
- On the one hand, the repetition of stressors during pregnancy corresponds to a natural chronic stress model of several months and thus allows to study the biological cost of responses to repeated stresses, and the adaptive mechanisms leading to From functional drift to psychic dysfunction.
- On the other hand, isolated vulnerability factors characterize a mirroring psychological profile of a Mindfulness type of functioning. Mindfulness or full consciousness has been described as a state of consciousness which results from intentionally, at the present moment, without judging the experience that unfolds moment by moment. This psychological resource has been associated with resilient or even resilient psychic functioning.
This study aim to follow a cohort of pregnant women from the first trimester of pregnancies to 2 months after the delivery to determine the predictive psychobiological factors of the emergence of postnatal depression
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- WOMEN DURING EARLY PREGNANCY
Key inclusion criteria (4 listed)
- Physiological pregnancy
- Follow-up of pregnancy in a participating maternity
- Female over 18 years
- Affiliated to a social security scheme
Key exclusion criteria (3 listed)
- Multiple pregnancy
- Psychiatric, neurological, or endocrine or autoimmune diseases
- Hormonal or psychotropic treatments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
post natal depression
Time frame: baseline at three 3 months of pregnancy and two months after labour delivery
change in Edimbourg Post-Partum Depression scale at two months after labour delivery
1 secondary outcome
allostatic load as a composite index including blood GABA, BDNF and 8iso-Prostaglandins and capillary cortisol + heart rate variability index
Time frame: baseline at three 3 months of pregnancy and two months after labour delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2020.
- Derived from this study: PubMed 29724735Tharwat D, Trousselard M, Bales M, Sutter-Dallay AL, Fromage D, Spitz E, Dallay D, Harvey T, Welter E, Coatleven F, Cherier L, Teissedre F, Pouly JL, Dutheil F, Duffaud AM. Chronic Stress protection for postnatal dEpREssioN prEvention (SERENE): a protocol for an exploratory study. BMJ Open. 2018 May 3;8(5):e018317. doi: 10.1136/bmjopen-2017-018317.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression, Postpartum, run by Institut de Recherche Biomedicale des Armees at 1 site 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 4 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: finished, as of the sponsor's last update on 12 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post natal depression (time frame: baseline at three 3 months of pregnancy and two months after labour delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03088319, which also lists 1 linked publication.
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 12 Feb 2020.