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Stop or Go?


Relapse prevention training with guided tapering of antidepressants during pregnancy.


Go to the www.stoporgostudie.nl website


Objective
About 2% women in the Netherlands use Selective Serotonin Reuptake Inhibitors (SSRs) during their pregnancy for symptoms of depression and/or anxiety. However, SSRI use in pregnancy is controversial. On the one hand SSRIs may be toxic to the intrauterine developing child, while on the other hand relapse of depression during pregnancy holds 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. No such studies exist to date.
The Stop or Go study aims to investigate the effect of relapse prevention training in combination with guided tapering of antidepressants during pregnancy. We will furthermore study the effects of continuation or tapering on both mother and child.


Study design
A nationwide pragmatic multi-center randomized controlled non-inferiority trial (RCT).


Study population
200 women who are between 8 and 16 weeks pregnant, use SSRIs and are currently without clinically relevant depressive symptoms.


Intervention [or: Methods]
Women will be recruited during their first prenatal visit in midwifery practices (first echelon care) and hospitals (second and third echelons care) or through advertisement in (social) media. After informed consent, women will be randomly allocated into two groups:

1. Gradual, guided discontinuation of SSRIs (conform protocol) under clinical management and additional cognitive therapy (relapse prevention training)
2. Continuation of SSRIs

The additional cognitive therapy will exist of 8 sessions by telephone and will be given by a trained therapist. The therapy is given to prevent relapse and is adjusted to the pregnant population.
All study procedures will be performed by the researchers of this project. Participating midwifery practices and hospitals will only ensure recruitment. They can continue their care as usual, without any interference with the study.


Outcome measures
Primary outcome :
Risk (cumulative incidence) 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 outcomes include:
Child condition at birth (standard birth outcomes)
Child neurodevelopmental outcome at 3 months (General Movements)
Child behavior (CBCL) at 18 months
Cost effectiveness (including indicated second echelon care, hospital delivery and clinical child observation in case of SSRI use)


Power/data analysis
Sample size calculation is based on the goal of this study, which is to demonstrate non-inferiority of preventive cognitive therapy with guided discontinuation of SSRIs compared to continuation, with respect to the risk of relapse of of anxiety and/or depressive disorder up to 3 months postnatal.We will use a non-inferiority margin (tolerance threshold, ‘delta’) of 15%. This is based on the assumption that relapse risk (taking into account the possibility of restoring SSRI treatment) is still in balance with the expected beneficial effects of discontinuation of SSRI on mother (the 85% remaining mothers) and child. We also anticipate that this balance is acceptable for women. With this non-inferiority margin, and the assumption that the overall absolute risk of relapse will be around 15%, we need 178 women. To account for attrition, we aim to include 200 women in total.


Economic evaluation
We will collect data from self-report questionnaires alongside the trial on direct and indirect medical costs, as well as quality of life, to estimate the cost-effectiveness of tapering versus continuation of antidepressants.


Time schedule
Inclusion will start January 2015. We aim to recruit 200 women in two years time. Total follow-up duration of each participant will be 30 months. Estimated end date would be December 2019.


Project leaders
Dr. Mijke Lambregtse-van den Berg, (child- and adolescent)psychiatrist, Erasmus MC
Prof. dr. Claudi Bockting, professor Clinical & Health psychology, clinical psychologist, Utrecht University
Dr. Huib Burger, associate professor of Epidemiology, general practitioner, University Medical Center Groningen
Prof.dr. Gouke Bonsel, professor perinatal health, Erasmus MC


Subsidy
ZonMW funded


Contact (researcher)
Drs. Nina Molenaar, MD & PhD candidate, Erasmus MC (primary contact)
Marlies Brouwer, MSc, psychologist & PhD candidate, Utrecht University
Tel: 06-49844950 / 030 253 23 87
E-mail:
stoporgo@erasmusmc.nl