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.
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
- Conditions the study is for
- Women Treated With Antidepressants During Pregnancy
- 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.
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.
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
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)
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:
- assessment of the psychometric properties of the AADP scale and identification of cut-off levels for low and high adherence to antidepressants in pregnancy;
- description of the extent to which women adhere to antidepressants in pregnancy;
- 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.
- First posted26 Jun 2024
- Study start15 Sep 2024
- Primary completion14 Mar 2025
- Study completion14 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Women Treated With Antidepressants During PregnancyStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 402 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilization of Antidepressants During Pregnancy: a Multinational Cross-sectional, Web-based Survey - French Contribution
- ClinicalTrials.gov ID
- NCT06476028
- Acronym / sponsor ID
- MAMP-DEP / APHP240101
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 402 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- University of Oslo
- Study start
- 15 Sep 2024 (actual)
- Primary completion
- 14 Mar 2025 (actual)
- Study completion
- 14 Mar 2025 (actual)
- First posted
- 26 Jun 2024 (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.
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.
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
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
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women treated with antidepressants during pregnancy
Key inclusion criteria (3 listed)
- Aged between 18 and 50 years
- Pregnant or have given birth in the past year.
- Used antidepressants 12 months before and/or during pregnancy
Key exclusion criteria (1 listed)
- Women under legal protection
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
develop an international scale for measuring adherence to antidepressants during pregnancy
Time frame: Through study time period, 6 months
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)
evaluate an international scale for measuring adherence to antidepressants during pregnancy
Time frame: Through study time period, 6 months
evaluate an international scale for measuring adherence to antidepressants during pregnancy (Adherence to Antidepressants in Pregnancy Scale ; AADP)
1 secondary outcome
estimate the prevalence of low antidepressant adherence, as well as associated maternal factors
Time frame: Through study time period, 6 months
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 27 Mar 2025.
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 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.