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Open Access 01-12-2016 | Study protocol

Stop or go? Preventive cognitive therapy with guided tapering of antidepressants during pregnancy: study protocol of a pragmatic multicentre non-inferiority randomized controlled trial

Authors: Nina M. Molenaar, Marlies E. Brouwer, Claudi L. H. Bockting, Gouke J. Bonsel, Christine N. van der Veere, Hanneke W. Torij, Witte J. G. Hoogendijk, Johannes J. Duvekot, Huibert Burger, Mijke P. Lambregtse-van den Berg

Published in: BMC Psychiatry | Issue 1/2016

Abstract

Background

Approximately 6.2 % of women in the USA and 3.7 % of women in the UK, use Selective Serotonin Reuptake Inhibitors (SSRIs) during their pregnancies because of depression and/or anxiety. In the Netherlands, this prevalence is around 2 %. Nonetheless, SSRI use during pregnancy is still controversial. On the one hand SSRIs may be toxic to the intrauterine developing child, while on the other hand relapse or recurrence of depression during pregnancy poses risks for both mother and child. Among patients and professionals there is an urgent need for evidence from randomized studies to make rational decisions regarding continuation or tapering of SSRIs during pregnancy. At present, no such studies exist.

Methods/Design

‘Stop or Go’ is a pragmatic multicentre randomized non-inferiority trial among 200 pregnant women with a gestational age of less than 16 weeks who use SSRIs without clinically relevant depressive symptoms. Women allocated to the intervention group will receive preventive cognitive therapy with gradual, guided discontinuation of SSRIs under medical management (STOP). Women in the control group will continue the use of SSRIs (GO). Primary outcome will be the (cumulative) incidence of relapse or recurrence of maternal depressive disorder (as assessed by the Structured Clinical Interview for DSM disorders) during pregnancy and up to three months postpartum. Secondary outcomes will be child outcome (neonatal outcomes and psychomotor and behavioural outcomes up to 24 months postpartum), and health-care costs. Total study duration for participants will be therefore be 30 months. We specified a non-inferiority margin of 15 % difference in relapse risk.

Discussion

This study is the first to investigate the effect of guided tapering of SSRIs with preventive cognitive therapy from early pregnancy onwards as compared to continuation of SSRIs during pregnancy. We will study the effects on both mother and child with a pragmatic approach. Additionally, the study examines cost effectiveness. If non-inferiority of preventive cognitive therapy with guided tapering of SSRIs compared to intended continuation of SSRIs is demonstrated for the primary outcome, this may be the preferential strategy during pregnancy.

Trial registration

Netherlands Trial Register (NTR): NTR4694; registration date: 16-jul-2014

Relapse is defined as the re-emergence of depressive symptoms during the remission phase, but before full recovery. Recurrence is defined as the onset of a new depression episode during the recovery phase or long remission phase.

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Title: Stop or go? Preventive cognitive therapy with guided tapering of antidepressants during pregnancy: study protocol of a pragmatic multicentre non-inferiority randomized controlled trial
Authors: Nina M. Molenaar
Marlies E. Brouwer
Claudi L. H. Bockting
Gouke J. Bonsel
Christine N. van der Veere
Hanneke W. Torij
Witte J. G. Hoogendijk
Johannes J. Duvekot
Huibert Burger
Mijke P. Lambregtse-van den Berg
Publication date: 01-12-2016
Publisher: BioMed Central
Published in: BMC Psychiatry / Issue 1/2016
Electronic ISSN: 1471-244X
DOI: https://doi.org/10.1186/s12888-016-0752-6

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Stop or go? Preventive cognitive therapy with guided tapering of antidepressants during pregnancy: study protocol of a pragmatic multicentre non-inferiority randomized controlled trial

Abstract

Background

Methods/Design

Discussion

Trial registration

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Abstract

Background

Methods/Design

Discussion

Trial registration

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