Clinical trial NCT01246765: National Pregnancy Registry for Psychiatric Medications
Official title: National Pregnancy Registry for Psychiatric Medications
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pregnant Women
Psychotropic Drugs
Keywords: Pregnancy
Medication use during pregnancy
Psychiatric medications
ADHD
Atypical Antipsychotics
Antidepressants
Sedative Hypnotics
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Alkermes, Inc.
name: Eisai Inc.
name: Janssen Pharmaceuticals
name: Otsuka America Pharmaceutical
name: Sage Therapeutics
name: Supernus Pharmaceuticals, Inc.
name: Teva Pharmaceuticals USA
First posted: 2010-11-23
Enrollment: 5000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women from across the United States will be enrolled in this registry.

Brief summary: 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.

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

Primary outcomes:
measure: Major Malformations in Infants
timeFrame: Birth up to 1 year; assessed at 8-12 weeks postpartum, assessed through medical records through 1 year of age.
Secondary outcomes:
measure: Maternal Gestational Weight Gain
timeFrame: Change from pre-pregnancy to delivery; assessed at 7 months' gestation and 8-12 weeks postpartum.
measure: Live Birth
timeFrame: Birth; assessed at 8-12 weeks postpartum.
measure: Spontaneous Abortion (SAB)
timeFrame: Any time during pregnancy; assessed at 7 months' gestation and 8-12 weeks postpartum.
measure: Intrauterine Fetal Demise (IUFD)
timeFrame: Any time during pregnancy; assessed at 7 months' gestation and 8-12 weeks postpartum.
measure: Gestational Age
timeFrame: Birth; assessed at 8-12 weeks postpartum.
measure: Preterm Delivery
timeFrame: Any time during pregnancy; assessed at 7 months' gestation and 8-12 weeks postpartum.
measure: Birth Weight
timeFrame: Birth; assessed at 8-12 weeks postpartum.
measure: Delivery Method
timeFrame: Birth; assessed at 8-12 weeks postpartum.
measure: Gestational Diabetes
timeFrame: Any time during pregnancy; assessed at baseline, 7 months' gestation and 8-12 weeks postpartum.
measure: Gestational Hypertension
timeFrame: Any time during pregnancy; assessed at baseline, 7 months' gestation and 8-12 weeks postpartum.
measure: Preeclampsia/Eclampsia
timeFrame: Any time during pregnancy; assessed at baseline, 7 months' gestation and 8-12 weeks postpartum.
measure: Maternal Postpartum Hemorrhage
timeFrame: Birth; assessed at 8-12 weeks postpartum.
measure: Apgar Scores
timeFrame: Birth; assessed at 8-12 weeks postpartum.
measure: Neonatal Intensive Care Unit (NICU) admission
timeFrame: Birth up to 1 year; assessed at 8-12 weeks postpartum, assessed through medical records through 1 year of age.
measure: Infant Death
timeFrame: Birth up to 1 year; assessed at 8-12 weeks postpartum, assessed through medical records through 1 year of age.
measure: Neonatal Extrapyramidal Symptoms
timeFrame: Birth through 1 year; assessed at 8-12 weeks postpartum, assessed through medical records through 1 year of age.
measure: Poor Neonatal Adaptation Syndrome (PNAS)
timeFrame: Birth through 1 year; assessed at 8-12 weeks postpartum, assessed through medical records through 1 year of age.
measure: Child Development Outcomes - Ages and Stages Questionnaire (ASQ-3)
timeFrame: Assessed at 9 months, year 3, and year 5.
measure: Child Development Outcomes - Preschool Child Behavior Checklist (CBCL)
timeFrame: Assessed at 9 months, year 3, and year 5.
measure: Breastfeeding
timeFrame: Assessed at 8-12 weeks postpartum.
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Lee S Cohen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. Epub 2015 Oct 6.
citation: 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.
citation: Freeman MP, Viguera AC, Goez-Mogollon L, Young AV, Caplin PS, McElheny SA, Church TR, Chitayat D, Hernandez-Diaz S, Cohen LS. Reproductive safety of aripiprazole: data from the Massachusetts General Hospital National Pregnancy Registry for Atypical Antipsychotics. Arch Womens Ment Health. 2021 Aug;24(4):659-667. doi: 10.1007/s00737-021-01115-6. Epub 2021 Mar 12.
citation: Cohen LS, Goez-Mogollon L, Sosinsky AZ, Savella GM, Viguera AC, Chitayat D, Hernandez-Diaz S, Freeman MP. Risk of Major Malformations in Infants Following First-Trimester Exposure to Quetiapine. Am J Psychiatry. 2018 Dec 1;175(12):1225-1231. doi: 10.1176/appi.ajp.2018.18010098. Epub 2018 Aug 16.
citation: Panchaud A, Hernandez-Diaz S, Freeman MP, Viguera AC, MacDonald SC, Sosinsky AZ, Cohen LS. Use of atypical antipsychotics in pregnancy and maternal gestational diabetes. J Psychiatr Res. 2017 Dec;95:84-90. doi: 10.1016/j.jpsychires.2017.07.025. Epub 2017 Jul 29.
citation: Cohen LS, Viguera AC, McInerney KA, Kwiatkowski MA, Murphy SK, Lemon EL, Hernandez-Diaz S. Establishment of the National Pregnancy Registry for Atypical Antipsychotics. J Clin Psychiatry. 2015 Jul;76(7):986-9. doi: 10.4088/JCP.14br09418.