Deepa Singal, PhD Candidate. 1 Manitoba Centre for Health Policy

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1 Childhood Neurodevelopmental, Heath & Educational Outcomes of Children Exposed to Antidepressants and Maternal Depression During Pregnancy Study Protocol Deepa Singal, PhD Candidate 1 Manitoba Centre for Health Policy

2 Research Team & Funding Deepa Singal Dr. Marni Brownell Dr. Dan Chateau Dr. Laurence Katz Dr. Chelsea Ruth Matt Dahl Farzana Quddus Manitoba Centre for Health Policy This study is supported by the Canadian Institutes of Health Research (Grant #142365) 2 Manitoba Centre for Health Policy

3 Mental Disorders & Women Mental disorders are among the leading cause of disability and illness in Western society 1. Women are two times more likely to be affected then men % experience depression during pregnancy 4. 3 Manitoba Centre for Health Policy

4 Antidepressant Use During Pregnancy 5-13% of women are treated with antidepressants during pregnancy 4-7. Selective Serotonin Reuptake Inhibitors (SSRIs) most commonly prescribed. 4 Manitoba Centre for Health Policy

5 Conflicting data regarding the risks of prenatal antidepressant use Evidence about the comparative benefits and harms of pharmacological treatment of depression in pregnancy and postpartum women was largely inadequate to allow informed decisions about treatment 8 (MgDonagh et al 2014) 5 Manitoba Centre for Health Policy

6 6 Manitoba Centre for Health Policy Conflicting Data

7 Emerging Data Antenatal SSRI exposure and an increased risk of Autism Spectrum Disorder (ASD). 6/8 studies confirm as association evidence must be interpreted with caution. 7 Manitoba Centre for Health Policy

8 Bound by the limitations of observational research Small sample sizes Recall bias Incomplete data on drug exposure Not enough follow up time to study outcomes in childhood and adolescence Difficult to control for confounding maternal lifestyle factors and comorbidities Distinguishing between the effect of medication exposure versus maternal depression Confounding by indication Confounding by severity of depression 8 Manitoba Centre for Health Policy

9 STUDY APPROACH: Utilizing administrative data to tease out a complex clinical challenge & address limitations of current evidence: Disentangle effects of in-utero antidepressant exposure from maternal depression and other prenatal confounding factors. Long term outcomes. Types of antidepressants, dose response & gestational timing of exposure. 9 Manitoba Centre for Health Policy

10 Primary Study Objectives (1) To determine whether prenatal exposure to antidepressant medications is associated with adverse birth and neonatal outcomes compared to untreated prenatal mood/anxiety disorders. (1) To determine if prenatal exposure to antidepressant medications is associated with adverse early childhood outcomes compared to untreated prenatal mood/anxiety disorders. 10 Manitoba Centre for Health Policy

11 Methodological Approach DATA SOURCE: Administrative data housed at the Manitoba Centre for Health Policy (MCHP) will be used to generate a population based cohort of all children born in Manitoba between 1996 and 2015 whose mother had a diagnosis of mood/anxiety disorder three months prior to conception Data linkage project children will be linked to their birth mothers using mother-child linkage developed at MCHP 11 Manitoba Centre for Health Policy

12 Datasets Linked for Study Psychiatric Morbidity Mood/Anxiety Disorders Antidepressant Exposure Study Population Exposed & Unexposed Groups Outcome Data Hospital Abstracts Employment & Income Assistance Census Data at area level Physician Claims Population-Based Research Registry Families First & Healthy Baby Programs Prescription Medications Education Data EDI Data Child & Family Services SES Demographics Confounding variables 12 Manitoba Centre for Health Policy

13 Identifying Exposures Exposure to mood/anxiety disorder: A woman is considered to have prenatal mood/anxiety disorders if in the 15 months prior to giving birth she had: one or more hospitalizations with a diagnosis for depressive disorder, affective psychoses, neurotic depression, or adjustment reaction OR one or more physician visits with a diagnosis for depressive disorder, affective psychoses, or adjustment reaction, OR one or more hospitalizations with a diagnosis for anxiety disorders, anxiety states, phobic disorders, or obsessive- compulsive disorders, OR two or more physician visits with a diagnosis for anxiety disorders. This definition was developed and used in a 2012 MCHP Report investigating Perinatal Services and Outcomes in Manitoba. 13 Manitoba Centre for Health Policy

14 Identifying Exposures Exposure to antidepressants will be defined by utilizing prescription drug data and the World Health Organization s Anatomical Therapeutic Chemical (ATC) classification codes, specifically all drugs coded as NO6A for antidepressants. SSRIs (fluoxetine, paroxetine, citalopram, fluvoxamine); SNRIs (effexor, xymbalta, savella, fetzima); Other antidepressants including: tricyclic antidepressants (amitriotyline, nortriyline, desipramine, imiparamine) and monoamine oxidase inhibitors. Exclusion criteria: Women exposed to antipsychotic medications and/or benzodiazepines 14 Manitoba Centre for Health Policy

15 Study Groups EXCLUDED Women exposed to antipsychotic medications or benzodiazepines or opioids are excluded STUDY POPULATION: All women with a live birth between and a diagnosis of mood/anxiety disorder 3 months prior to conception EXPOSED GROUP 1: Children whose mother had at least 2 prescriptions for an AD during pregnancy UNEXPOSED GROUP: Children whose mothers had a diagnosis of mood/anxiety disorder during pregnancy but did not have a prescription of an AD EXPOSED GROUP 2: AD prescription in the 1 st trimester EXPOSED GROUP 3: AD prescription in the 2nd trimester EXPOSED GROUP 4: AD prescription in the 3 rd trimester 15 Manitoba Centre for Health Policy

16 Study Outcomes Neonatal outcomes Neonatal and infant mortality Birth weight Preterm birth 5 minute Apgar score NICU admissions Breastfeeding initiation Persistent pulmonary hypertension Postnatal adaption syndrome: respiratory distress, confusions, feeding difficulties, jaundice Congenital anomalies down syndrome, congenital heart defects Severe Neonatal morbidity Childhood outcomes Neurodevelopmental disorders: autism Learning disabilities, diabetes, epilepsy, language difficulties Educational outcomes: grade repetition, high school completion, school assessments Mental Health: Mood and anxiety disorders, substance use, personality disorders, schizophrenia, suicide, oppositional defiant disorder 16 Manitoba Centre for Health Policy

17 Proposed Analysis Propensity scores will be used to construct Inverse Probability Treatment Weights (IPTW). IPTWs will balance differences in observed characteristics between exposed and unexposed groups. Attempt to control for confounding by indication and depression severity Number of visits to a psychiatrist Number of times diagnosed with a mood/anxiety disorder Number of times diagnosed as having any mental disorder Number of hospitalizations Number of antidepressant prescriptions History of suicide attempts 17 Manitoba Centre for Health Policy

18 SES Covariates used for propensity mothers age history of teen birth education level weights: receipt of community prenatal support program Adequacy of prenatal care Co-morbid mental illness Co-morbid chronic illness Prenatal alcohol/substance use Known or suspected risk factors for certain outcomes eg. Congenital cardiac malformation maternal hypertension, diabetes, renal disease 18 Manitoba Centre for Health Policy

19 Study Strengths (1) Largest sample size 7.5% of women were diagnosed with prenatal psychological distress (including depression) out of 15,000 births in 2008/2009. Over 20,0000 women diagnosed with prenatal psychological distress. (2) Clinically relevant comparison groups (3) Accurate exposure data and the ability for sensitivity analysis (4) Accurate, validated, and novel longitudinal health social and education data for outcome measures (5) Powerful statistical methodology to control for important confounding variables 19 Manitoba Centre for Health Policy

20 Limitations 1. Lack of data on non-pharmaceutical treatment of mood/anxiety disorders. 2. Assumption that all women prescribed antidepressants are actually taking the medication can result in overestimation of exposure. 3. Quality of the data extensively validated for this type of research. 4. Potential for unmeasured confounding. 20 Manitoba Centre for Health Policy

21 Study Implications: Improve the care of women during pregnancy. Equipping physicians and patients with high quality up date evidence. Inform decisions about treating mood/anxiety disorders. Teasing out an important clinical quandary antidepressants versus untreated mood/anxiety disorders. 21 Manitoba Centre for Health Policy

22 Recognizing the challenges of clinical management Clinical management of severe depression during pregnancy is a challenge. Difficult for patients to stop medications during pregnancy. Cannot be a categorical approach: Not our intention to suggest that AD should always be avoided or always prescribed. Benefits outweigh harms. 22 Manitoba Centre for Health Policy

23 Questions? Thank-you for your time. Further inquires: 23 Manitoba Centre for Health Policy

24 References 1. Data and statistics: prevalence of mental disorders ; Accessed Februrary De las Cuevas C, Sanz E. Do therapeutic indications of antidepressants change from one year to another? Pharmacoepidemiology and drug safety. May 2004;13(5): Hansen DG, Sondergaard J, Vach W, Gram LF, Rosholm JU, Kragstrup J. Antidepressant drug use in general practice: inter-practice variation and association with practice characteristics. European journal of clinical pharmacology. Jun 2003;59(2): Cooper WO, Willy ME, Pont SJ, Ray WA. Increasing use of antidepressants in pregnancy. American journal of obstetrics and gynecology. Jun 2007;196(6):544 e Cooper WO, Willy ME, Pont SJ, Ray WA. Increasing use of antidepressants in pregnancy. American journal of obstetrics and gynecology. Jun 2007;196(6):544 e Oberlander TF, Warburton W, Misri S, Aghajanian J, Hertzman C. Neonatal outcomes after prenatal exposure to selective serotonin reuptake inhibitor antidepressants and maternal depression using population-based linked health data. Archives of general psychiatry. Aug 2006;63(8): Daw JR, Hanley GE, Greyson DL, Morgan SG. Prescription drug use during pregnancy in developed countries: a systematic review. Pharmacoepidemiology and drug safety. Sep 2011;20(9): Daw JR, Mintzes B, Law MR, Hanley GE, Morgan SG. Prescription drug use in pregnancy: a retrospective, population-based study in British Columbia, Canada ( ). Clinical therapeutics. Jan 2012;34(1): e McDonagh MS, Matthews A, Phillipi C, et al. Depression drug treatment outcomes in pregnancy and the postpartum period: a systematic review and meta-analysis. Obstetrics and gynecology. Sep 2014;124(3): Manitoba Centre for Health Policy

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