Ignite Creation Date:
2024-07-17 @ 10:51 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06476028
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-06-13
Brief Title:
Adherence to Antidepressants During Pregnancy
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Utilization of Antidepressants During Pregnancy a Multinational Cross-sectional Web-based Survey - French Contribution
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MAMP-DEP
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 womans 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
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 womans 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 30 95 CI 23-37 serotonin-norepinephrine reuptake inhibitors SNRIs 07 95 CI 05-09 and tricyclic antidepressants TCAs 04 95 CI 03-05 Prevalence estimates have shown significant variation by geographical region with a prevalence estimate of 16 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 womans 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
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 30 95 CI 23-37 serotonin-norepinephrine reuptake inhibitors SNRIs 07 95 CI 05-09 and tricyclic antidepressants TCAs 04 95 CI 03-05 Prevalence estimates have shown significant variation by geographical region with a prevalence estimate of 16 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 womans 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None