Stop or go?
| Autor: | Molenaar, Nina, Brouwer, M. E., Bockting, C. L. H., Bonsel, G. J., Van der Veere, C. N., Torij, H. W., Hoogendijk, W., Duvekot, J. J., Burger, H. N., Lambregtse-van den Berg, M. P., Trauma and Grief, Leerstoel Bockting |
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| Přispěvatelé: | Psychiatry, Obstetrics & Gynecology, Medical Oncology, Child and Adolescent Psychiatry / Psychology, Trauma and Grief, Leerstoel Bockting, Adult Psychiatry, APH - Mental Health, Amsterdam Neuroscience - Mood, Anxiety, Psychosis, Stress & Sleep, Public and occupational health, Interdisciplinary Centre Psychopathology and Emotion regulation (ICPE), Reproductive Origins of Adult Health and Disease (ROAHD), Life Course Epidemiology (LCE) |
| Jazyk: | angličtina |
| Rok vydání: | 2016 |
| Předmět: |
Pediatrics
Cost effectiveness SEROTONIN REUPTAKE INHIBITORS medicine.medical_treatment POPULATION-BASED COHORT Social Sciences Antidepressive Agents/therapeutic use law.invention COST-EFFECTIVENESS Study Protocol 0302 clinical medicine Randomized controlled trial Clinical Protocols law Recurrence Pregnancy Medicine and Health Sciences SSRI Depressive Disorder/drug therapy RECURRENT DEPRESSION 030212 general & internal medicine Relapse Netherlands Psychomotor learning MAJOR DEPRESSIVE DISORDER Depression digestive oral and skin physiology GENERAL MOVEMENTS Antidepressants Antidepressive Agents Psychiatry and Mental health Prenatal Exposure Delayed Effects antidepressants Major depressive disorder Anxiety Female medicine.symptom Psychology MENTAL-HEALTH Adult medicine.medical_specialty Prenatal Exposure Delayed Effects/prevention & control MATERNAL DEPRESSION PRETERM BIRTH Cognitive therapy behavioral disciplines and activities 03 medical and health sciences Selective serotonin reuptake inhibitors mental disorders medicine Humans study Psychiatry PRENATAL EXPOSURE Depressive Disorder Cognitive Behavioral Therapy Prevention Cognitive Behavioral Therapy/methods Perinatal outcome medicine.disease 030227 psychiatry Discontinuation cognitive therapy Cost-effectiveness Serotonin Uptake Inhibitors/therapeutic use |
| Zdroj: | BMC Psychiatry, 16(1):72. BioMed Central Ltd. BMC Psychiatry, 16(72), 1-10. BMC BMC psychiatry, 16. BioMed Central BMC Psychiatry, 16(72), 1. BioMed Central BMC Psychiatry BMC PSYCHIATRY BMC Psychiatry, 16(1):72. BMC |
| ISSN: | 1471-244X |
| DOI: | 10.1186/s12888-016-0752-6 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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