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Women Treated With Antidepressants During PregnancyMAMP-DEPNCT06476028

Adherence to Antidepressants During Pregnancy

An observational study of Women Treated With Antidepressants During Pregnancy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Depression is one of the most common psychiatric disorders accompanying pregnancy and the postpartum period. In Western countries, it is estimated that up to 18% of women experience depression during pregnancy, and 13% have at least one episode of severe depression. Read more about this study

Who is it for?
Ages 18 to 50 years, women only
How many people
402 participants
Where
1 siteFrance
Study dates
15 Sep 2024to 14 Mar 2025
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 50 years
  • Women only
  • No healthy volunteers
  • Adult

Study population: Women treated with antidepressants during pregnancy

Who may be able to join

  • Aged between 18 and 50 years
  • Pregnant or have given birth in the past year.
  • Used antidepressants 12 months before and/or during pregnancy

Who cannot join

  • Women under legal protection

Trial locations and contacts

1 site in 1 country.

France1 site
  • Hôpital Trousseau

    Paris, 75012

Other trials in France

About this study

Official title: Utilization of Antidepressants During Pregnancy: a Multinational Cross-sectional, Web-based Survey - French Contribution

Depression is one of the most common psychiatric disorders accompanying pregnancy and the postpartum period. In Western countries, it is estimated that up to 18% of women experience depression during pregnancy, and 13% have at least one episode of severe depression.

Although non-pharmacological interventions are of central importance in treating depression and anxiety, especially during pregnancy, for some women, pharmacological interventions are necessary.

Read more

While prescription data is inadequate to capture real-life adherence to medication, there is also a lack of suitable self-completed scales to measure adherence to antidepressants among pregnant women. The information the investigators currently have on adherence to antidepressants in pregnancy is from the studies that have used pregnancy non-specific measurements, which do not consider pregnancy-related factors that could influence adherence, including fear of the potential teratogenic risk of antidepressants or untreated psychiatric disorders to the fetus and specific pregnancy-related concerns, such as being a good mother and bonding with a child that is going to be born.

In this study, the investigators will develop and adherence scale dedicated to antidepressant treatement during pregnancy and investigators will include pregnancy-specific predictors of antidepressant adherence as well as the woman's beliefs and perceptions regarding such use.

The recruitment of the patients will be done in various countries from Europe. This protocol covers the French contribution to this international initiative

Read the detailed description

Depression is one of the most common psychiatric disorders accompanying pregnancy and the postpartum period.

In Western countries, it is estimated that up to 18% of women experience depression during pregnancy, and 13% have at least one episode of severe depression. Anxiety disorders are also common in the perinatal period, with a prevalence estimate of 15%. In many cases, these disorders concur, adding substantial illness burden to the woman.

Although non-pharmacological interventions are of central importance in treating depression and anxiety, especially during pregnancy, for some women, pharmacological interventions are necessary.

Selective serotonin reuptake inhibitors (SSRIs) are in the first line of the pharmacological treatment of depression and anxiety, but depending on the clinical situation, the choice is often between SSRIs (international prevalence of use in pregnancy: 3.0% [95% CI 2.3-3.7]), serotonin-norepinephrine reuptake inhibitors (SNRIs; 0.7% [95% CI 0.5-0.9]) and tricyclic antidepressants (TCAs; 0.4% [95% CI 0.3-0.5]). Prevalence estimates have shown significant variation by geographical region, with a prevalence estimate of 1.6% for SSRIs in Europe.

When choosing treatment options for pregnant women, three crucial aspects must be considered: the benefits of the treatment, the risks of the treatment, and the risks of untreated disease for both mother and child.

Overestimation of the medication risk often results in the discontinuation of pharmacological therapy. Every other pregnant woman on antidepressant treatment prior to pregnancy stops using the treatment, usually during the first six weeks of the pregnancy. Even among women continuing antidepressants during pregnancy, one in two has a low level of adherence to therapy.

The benefit of continued use of antidepressants for relapse prevention in pregnant women seems to be more prominent among women having severe depression.

Depression left untreated in pregnancy can lead to negative consequences for the mother, child, and family as a whole, including poor living and eating habits, substance abuse, suicidal thoughts, thoughts of harming the infant, and the development of postpartum depression. Untreated depressive symptoms and poor health behaviors in pregnancy may increase the risk of preterm birth, low birth weight, and developmental problems in offspring. Maternal anxiety during pregnancy is also positively related to behavioral, cognitive, and emotional difficulties in offspring, and is associated with an increased risk of preterm birth and low birth weight. Being adherent to antidepressants is of special importance to women with severe or recurrent depression, who are at an increased risk of relapse following antidepressant discontinuation.

While prescription data is inadequate to capture real-life adherence to medication, there is also a lack of suitable self-completed scales to measure adherence to antidepressants among pregnant women. The information investigators currently have on adherence to antidepressants in pregnancy is from the studies that have used pregnancy non-specific measurements, which do not consider pregnancy-related factors that could influence adherence, including fear of the potential teratogenic risk of antidepressants or untreated psychiatric disorders to the fetus and specific pregnancy-related concerns, such as being a good mother and bonding with a child that is going to be born.

In this study, the adherence scale to be developed includes pregnancy-specific predictors of antidepressant adherence as well as the woman's beliefs and perceptions regarding such use. It will ideally enable tailored interventions in practice, which would improve antidepressant adherence and the outcome of antidepressant therapy.

The recruitment of the patients will be done in various countries from Europe. This protocol covers the French contribution to this international initiative

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. develop an international scale for measuring adherence to antidepressants during pregnancy

    develop an international scale for measuring adherence to antidepressants during pregnancy, building upon the scale previously piloted in a Norwegian population (Adherence to Antidepressants in Pregnancy Scale ; AADP)

    Measured: Through study time period, 6 months

  2. evaluate an international scale for measuring adherence to antidepressants during pregnancy

    evaluate an international scale for measuring adherence to antidepressants during pregnancy (Adherence to Antidepressants in Pregnancy Scale ; AADP)

    Measured: Through study time period, 6 months

Secondary outcomes (1)
  1. estimate the prevalence of low antidepressant adherence, as well as associated maternal factors

    The secondary aim is to estimate the prevalence of low antidepressant adherence, as well as associated maternal factors.

    This will be done through the following specific objectives:

    1. assessment of the psychometric properties of the AADP scale and identification of cut-off levels for low and high adherence to antidepressants in pregnancy;
    2. description of the extent to which women adhere to antidepressants in pregnancy;
    3. determination of the maternal factors associated with low adherence to antidepressants during pregnancy.

    Measured: Through study time period, 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2024
  2. Study start15 Sep 2024
  3. Primary completion14 Mar 2025
  4. Study completion14 Mar 2025

Resources

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
Other
Time perspective
Prospective
Enrolment
402 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06476028
Sponsor's protocol ID
APHP240101
Acronym
MAMP-DEP
Status last verified
Mar 2025
First submitted
13 Jun 2024
Last updated
27 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Women Treated With Antidepressants During Pregnancy, run by Assistance Publique - Hôpitaux de Paris 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 3 inclusion and 1 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 27 Mar 2025. 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?

develop an international scale for measuring adherence to antidepressants during pregnancy (time frame: Through study time period, 6 months). The study lists 2 primary outcomes in all. 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 27 Mar 2025.

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