Adherence to Antidepressants During Pregnancy

NCT06476028 | Completed

• 1 other identifier: APHP240101
• Study Type: observational
• Target: 402
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Women Treated With Antidepressants During Pregnancy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• estimate the prevalence of low antidepressant adherence, as well as associated maternal factors

  Through study time period, 6 months

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women treated with antidepressants during pregnancy

You may qualify if:

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

You may not qualify if:

• Women under legal protection

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• University of Oslo: collaborator

Study Sites (1)

Hôpital Trousseau

Paris, 75012, France

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2024
• First Posted: June 26, 2024
• Study Start: September 15, 2024
• Primary Completion: March 14, 2025
• Study Completion: March 14, 2025
• Last Updated: March 27, 2025

Record last verified: 2025-03

Locations

FR (1)