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About 2% women use Selective Serotonin Reuptake Inhibitors (SSRIs) during pregnancy for symptoms of anxiety and/or depression. SSRI use in pregnancy is controversial. On the one hand SSRIs may be toxic to the intrauterine developing child, on the other hand, relapse of depression and/or anxiety during pregnancy holds risks for mother and child. Among patients and professionals there is an urgent need for evidence from randomized studies to make rational decisions around continuing or tapering of SSRIs during pregnancy. No such studies exist to date.

The aim of this study is to investigate the effect of guided tapering of SSRI and additional preventive cognitive therapy in early pregnancy as compared to continuation of SSRIs during pregnancy. We will include 200 women who use an SSRI at their first antenatal visit (<16 weeks gestation), without clinical anxiety and/or depression. Women will be randomized to either continuation or guided tapering of SSRI under clinical management and additional preventive cognitive therapy.

This study quantifies the effects of SSRI tapering on mother, child and cost effectiveness outcomes:

 

PRIMARY OUTCOME

Time to relapse of maternal anxiety and/or depressive disorder (as defined by the Structured Clinical Interview for DSM disorders) during pregnancy up to 3 months postnatal.

 

SECONDARY OUTCOMES

- Child neurodevelopmental outcome at 3 months (General Movements)

- Cost effectiveness (incl. indicated second echelon care, hospital delivery and clinical child observation in case of SSRI use)

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