Adherence to Antidepressants During Pregnancy
NCT Number: NCT06476028
Acronym: MAMP-DEP
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Women Treated With Antidepressants During Pregnancy
Sponsor: Assistance Publique - Hôpitaux de Paris
Collaborators: University of Oslo
Sex: FEMALE
Age: ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2025-03-01

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.

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

Primary Outcome Measures: 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), 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), Through study time period, 6 months
Secondary Outcome Measures: 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., Through study time period, 6 months