Ignite Creation Date:
2024-05-05 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00279370
Status:
COMPLETED
Last Update Posted:
2013-10-07
First Post:
2006-01-17
Brief Title:
Antidepressant Use During Pregnancy
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Antidepressant Use During Pregnancy
Status:
COMPLETED
Status Verified Date:
2013-09
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:
None
Brief Summary:
This study will determine the safety of antidepressant use during pregnancy for both the mother and the child
Detailed Description:
Symptoms of major depressive disorder MDD include persistent sad mood feelings of hopelessness or guilt decreased energy irritability and more If untreated MDD can interfere with the ability to work study sleep eat and enjoy once pleasurable activities MDD occurs most commonly in females between the ages of 25 and 44 This puts women of childbearing age at a particularly high risk for developing the disorder However very little research has been done to determine the safety of antidepressant use during pregnancy and how the medication may affect the baby This study will determine the safety of antidepressant use during pregnancy for both the mother and the child
Participants in this observational study will not receive medication or treatment of any kind Pregnant woman who are already taking medication for depression will be recruited in addition to pregnant women who are not taking any medication The participants will first undergo interviews to establish their psychiatric diagnoses Subsequent interviews will be held to monitor levels of depressive symptoms exposure to other substances that could potentially harm the fetus levels of antidepressants in the blood and dietary intake during pregnancy Participants will report to the study site for these evaluations at Weeks 20 30 and 36 of pregnancy From Week 36 to Week 40 interviews will be conducted over the phone
At birth cord blood will be collected and the infants cries will be recorded The infants development will be assessed at 2 weeks and 3 6 ½ 12 18 and 24 months postpartum Mothers who take selective serotonin reuptake inhibitors SSRIs and are breastfeeding their children will report to the study site with their children at 1 month postpartum to measure the level of SSRIs in the infants blood In addition digital photographs of the infants face profile hands and torso will be taken at 2 weeks and 3 12 and 24 months postpartum Additional face-only photographs of the infant will be taken at these times and at birth for further in-depth analyses of facial characteristics Mother-child interactions will be videotaped at all postpartum assessments
Participants in this observational study will not receive medication or treatment of any kind Pregnant woman who are already taking medication for depression will be recruited in addition to pregnant women who are not taking any medication The participants will first undergo interviews to establish their psychiatric diagnoses Subsequent interviews will be held to monitor levels of depressive symptoms exposure to other substances that could potentially harm the fetus levels of antidepressants in the blood and dietary intake during pregnancy Participants will report to the study site for these evaluations at Weeks 20 30 and 36 of pregnancy From Week 36 to Week 40 interviews will be conducted over the phone
At birth cord blood will be collected and the infants cries will be recorded The infants development will be assessed at 2 weeks and 3 6 ½ 12 18 and 24 months postpartum Mothers who take selective serotonin reuptake inhibitors SSRIs and are breastfeeding their children will report to the study site with their children at 1 month postpartum to measure the level of SSRIs in the infants blood In addition digital photographs of the infants face profile hands and torso will be taken at 2 weeks and 3 12 and 24 months postpartum Additional face-only photographs of the infant will be taken at these times and at birth for further in-depth analyses of facial characteristics Mother-child interactions will be videotaped at all postpartum assessments
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DSIR AT-SO | US NIH GrantContract | None | httpsreporternihgovquickSearchR01MH060335 |
| R01MH060335 | NIH | None | None |