Stop or Go? Tapering antidepressants in pregnancy: A pragmatic multicenter RCT to investigate risk and benefits for mother and child.

Stop or Go? Tapering antidepressants in pregnancy: A pragmatic multicenter RCT to investigate risk and benefits for mother and child. - Stop or Go?

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON44592

Enrollment

200

Registered

2015-01-26

Start date

2015-01-01

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

effecten op kind na de geboorte Depression depressive disorder

Interventions

1. Preventive cognitive therapy with guided tapering of SSRIs 2. Continuation of SSRIs

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria:

Exclusion criteria

Exclusion criteria: Multiple pregnancies Severe medical conditions Current relapse of depression Current other severe psychiatric disorders

Design outcomes

Primary

Measure	Time frame
Risk of relapse of maternal depressive disorder (as defined by the Structured Clinical Interview for DSM disorders) during pregnancy and up to 3 months postnatal.	—

Secondary

Measure	Time frame
Mother: - Time to relapse of depressive disorder up to 3 months after delivery. - SSRI use and dosage, psychiatric co-medication (e.g. benzodiazepines), adherence to preventive cognitive therapy - Side effects of (tapering of) medication (checklist) - Hazardous behavior (e.g. use of alcohol/drugs, suicidality) - Stress, depressive symptoms, anxiety and childhood trauma - Direct medical costs (until 3 months postpartum), indirect costs (with adjustment for pregnancy leave period), quality of life effects mother - Obstetric complications during pregnancy and delivery (spontaneous abortion, referral midwife to obstetrician, preeclampsia [ISSHP definition], assisted delivery, induced labour for maternal indication [premature, term delivery], epidural anaesthesia for pain, caesarean section) Child: - Specific: child condition at birth (poor neonatal adaptation defined as: 5-min Apgar	—

Measure

Time frame

Mother: - Time to relapse of depressive disorder up to 3 months after delivery. - SSRI use and dosage, psychiatric co-medication (e.g. benzodiazepines), adherence to preventive cognitive therapy - Side effects of (tapering of) medication (checklist) - Hazardous behavior (e.g. use of alcohol/drugs, suicidality) - Stress, depressive symptoms, anxiety and childhood trauma - Direct medical costs (until 3 months postpartum), indirect costs (with adjustment for pregnancy leave period), quality of life effects mother - Obstetric complications during pregnancy and delivery (spontaneous abortion, referral midwife to obstetrician, preeclampsia [ISSHP definition], assisted delivery, induced labour for maternal indication [premature, term delivery], epidural anaesthesia for pain, caesarean section) Child: - Specific: child condition at birth (poor neonatal adaptation defined as: 5-min Apgar

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)