National Pregnancy Registry for Psychiatric Medications

Overview

The National Pregnancy Registry for Psychiatric Medications is dedicated to evaluating the safety of psychiatric medications such as antidepressants, ADHD medications, sedative hypnotics, and atypical antipsychotics that many people take during pregnancy to treat a wide range of mood, anxiety, executive function, or psychiatric disorders. The goal of this Registry is to gather information on the safety of these medications during pregnancy, as current data is limited.

Detailed description

The overarching objectives of the National Pregnancy Registry for Psychiatric Medications are twofold: to assess risk for malformations among infants exposed to specific psychiatric medications and to assess neonatal outcomes associated with prenatal exposure to such medication. Specifically, the Registry will allow us to prospectively determine whether exposure to psychiatric medication is associated with any increased risk for major malformations above the baseline risk noted in the general population. This will be achieved by careful systematic documentation of medication exposure during pregnancy, as well as other relevant exposures often not included in small case series or published reviews of drug safety derived from large administrative databases.

Although psychiatric medications are widely used by reproductive age women, reliable data regarding the reproductive safety of many of these compounds is limited. As a result, clinicians often lack sufficient evidence to evaluate the risks and benefits of using medications to treat psychiatric disorders during pregnancy. The National Pregnancy Registry for Psychiatric Medications is one of the first, and largest, hospital-based pregnancy registries which will systematically and prospectively monitor pregnancy outcomes after exposure to psychiatric medications, including antidepressants, ADHD medications, sedative hypnotics, and atypical antipsychotics.

Primary Aim:

To prospectively evaluate rates of congenital malformations among infants exposed in-utero to psychiatric medications.

Secondary Aims:

1. To evaluate neonatal outcomes of infants with prenatal exposure to specific psychiatric medications alone or in combination with other psychotropics. 2. To evaluate maternal health outcomes associated with use of psychiatric medications during pregnancy. 3. To evaluate neurobehavioral development of children (1 month and older) with prenatal exposure to psychiatric medications.

Primary outcome measures

• Major Malformations in Infants [Time frame: Birth up to 1 year; assessed at 8-12 weeks postpartum, assessed through medical records through 1 year of age.]

Secondary outcome measures (12)

• Maternal Gestational Weight Gain [Time frame: Change from pre-pregnancy to delivery; assessed at 7 months' gestation and 8-12 weeks postpartum.]
• Live Birth [Time frame: Birth; assessed at 8-12 weeks postpartum.]
• Spontaneous Abortion (SAB) [Time frame: Any time during pregnancy; assessed at 7 months' gestation and 8-12 weeks postpartum.]
• Intrauterine Fetal Demise (IUFD) [Time frame: Any time during pregnancy; assessed at 7 months' gestation and 8-12 weeks postpartum.]
• Gestational Age [Time frame: Birth; assessed at 8-12 weeks postpartum.]
• Preterm Delivery [Time frame: Any time during pregnancy; assessed at 7 months' gestation and 8-12 weeks postpartum.]
• Birth Weight [Time frame: Birth; assessed at 8-12 weeks postpartum.]
• Delivery Method [Time frame: Birth; assessed at 8-12 weeks postpartum.]
• Gestational Diabetes [Time frame: Any time during pregnancy; assessed at baseline, 7 months' gestation and 8-12 weeks postpartum.]
• Gestational Hypertension [Time frame: Any time during pregnancy; assessed at baseline, 7 months' gestation and 8-12 weeks postpartum.]
• Preeclampsia/Eclampsia [Time frame: Any time during pregnancy; assessed at baseline, 7 months' gestation and 8-12 weeks postpartum.]
• Maternal Postpartum Hemorrhage [Time frame: Birth; assessed at 8-12 weeks postpartum.]

Eligibility criteria

Inclusion criteria

• Pregnant women
• Age 18-45
• Subjects will be willing to participate over the phone
• Subjects will be able to provide informed consent

Exclusion criteria

• Women who have completed their pregnancy
• Women who are planning to become pregnant
• Women who are not taking any psychiatric medications and/or have no history of psychiatric illness

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model

Case-control

Study locations

United States · 1 center

• Massachusetts General Hospital — Boston

Publications

• Cohen LS, Viguera AC, McInerney KA, Freeman MP, Sosinsky AZ, Moustafa D, Marfurt SP, Kwiatkowski MA, Murphy SK, Farrell AM, Chitayat D, Hernandez-Diaz S. Reproductive Safety of Second-Generation Antipsychotics: Current Data From the Massachusetts General Hospital National Pregnancy Registry for Atypical Antipsychotics. Am J Psychiatry. 2016 Mar 1;173(3):263-70. doi: 10.1176/appi.ajp.2015.15040506. PMID 26441156
• Swetlik C, Cohen LS, Kobylski LA, Sojka ET, Killenberg PC, Freeman MP, Viguera AC. Effects of Prenatal Exposure to Second-Generation Antipsychotics on Development and Behavior Among Preschool-Aged Children: Preliminary Results From the National Pregnancy Registry for Psychiatric Medications. J Clin Psychiatry. 2024 Mar 13;85(1):23m14965. doi: 10.4088/JCP.23m14965. PMID 38488388
• Szpunar MJ, Freeman MP, Kobylski LA, Rossa ET, Gaccione P, Chitayat D, Viguera AC, Cohen LS. Risk of Major Malformations in Infants After First-Trimester Exposure to Stimulants: Results From the Massachusetts General Hospital National Pregnancy Registry for Psychiatric Medications. J Clin Psychopharmacol. 2023 Jul-Aug 01;43(4):326-332. doi: 10.1097/JCP.0000000000001702. Epub 2023 May 29. PMID 37235505
• Viguera AC, Freeman MP, Kobylski LA, Rossa ET, Gaccione P, Chitayat D, Hernandez-Diaz S, Cohen LS. Risk of Major Malformations Following First-Trimester Exposure to Olanzapine: Preliminary Data From the Massachusetts General Hospital National Pregnancy Registry for Psychiatric Medications. J Clin Psychopharmacol. 2023 Mar-Apr 01;43(2):106-112. doi: 10.1097/JCP.0000000000001665. PMID 36825887
• Cohen LS, Church TR, Freeman MP, Gaccione P, Caplin PS, Kobylski LA, Arakelian M, Rossa ET, Chitayat D, Hernandez-Diaz S, Viguera AC. Reproductive Safety of Lurasidone and Quetiapine: Update from the National Pregnancy Registry for Psychiatric Medications. J Womens Health (Larchmt). 2023 Apr;32(4):452-462. doi: 10.1089/jwh.2022.0310. Epub 2023 Jan 30. PMID 36716275
• Viguera AC, McElheny SA, Caplin PS, Kobylski LA, Rossa ET, Young AV, Gaccione P, Goez-Mogollon L, Freeman MP, Cohen LS. Risk of Poor Neonatal Adaptation Syndrome Among Infants Exposed to Second-Generation Atypical Antipsychotics Compared to Antidepressants: Results From the National Pregnancy Registry for Psychiatric Medications. J Clin Psychiatry. 2023 Jan 4;84(1):22m14492. doi: 10.4088/JCP.22m14 PMID 36602927
• Szpunar MJ, Freeman MP, Kobylski LA, Caplin PS, Gaccione P, Viguera AC, Chitayat D, Hernandez-Diaz S, Cohen LS. Risk of major malformations in infants after first-trimester exposure to benzodiazepines: Results from the Massachusetts General Hospital National Pregnancy Registry for Psychiatric Medications. Depress Anxiety. 2022 Dec;39(12):751-759. doi: 10.1002/da.23280. Epub 2022 Jul 31. PMID 35909254
• Viguera AC, Freeman MP, Goez-Mogollon L, Sosinsky AZ, McElheny SA, Church TR, Young AV, Caplin PS, Chitayat D, Hernandez-Diaz S, Cohen LS. Reproductive Safety of Second-Generation Antipsychotics: Updated Data From the Massachusetts General Hospital National Pregnancy Registry for Atypical Antipsychotics. J Clin Psychiatry. 2021 Aug 3;82(4):20m13745. doi: 10.4088/JCP.20m13745. PMID 34352165

Identifiers

NCT: NCT01246765 · 2008P-001861

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗