National Pregnancy Registry for Psychiatric Medications

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.

Study Overview

• Status: Recruiting
• Conditions: Pregnant Women; Psychotropic Drugs

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.

• Study Type: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

• Study Contact: Name: Bryn Rediger; Phone Number: (617) 724-8020; Email: brediger@partners.org
• Study Contact Backup: Name: Lee Cohen, MD; Phone Number: (617) 724-8020; Email: lcohen2@partners.org

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
      • Contact: Bryn Rediger, BA; Phone Number: (617) 724-8020; Email: admin@womensmentalhealth.org
      • Principal Investigator: Lee Cohen, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Pregnant women from across the United States will be enrolled in this registry.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort
Atypical Antipsychotic Cohort; Pregnant women who have taken at least one type of atypical antipsychotic at some point during pregnancy. Medications of Special Interest: Abilify (aripiprazole); Aristada (aripiprazole lauroxil); Aristada Initio (aripiprazole lauroxil); Clozaril (clozapine); Lybalvi (olanzapine and samidorphan); Rexulti (brexpiprazole); Risperdal (risperidone); Seroquel (quetiapine); Symbax (olanzapine-fluoxetine HCL); Zyprexa (olanzapine)
Antidepressant Medications; Pregnant women who have taken at least one type of antidepressant medication at some point during pregnancy. Medications of Special Interest: Spravato (esketamine); Zulresso (brexanolone)
ADHD Medications; Pregnant women who have taken at least one type of ADHD medication at some point during pregnancy. Medications of Special Interest: • Qelbree (viloxazine)
Sedative Hypnotic Medications; Pregnant women who have taken at least one type of sedative hypnotic medication at some point during pregnancy. Medications of Special Interest: • Dayvigo (lemborexant)
Other Psychiatric Medications; Pregnant women who have taken other psychiatric medications (other than atypical antipsychotics, ADHD medications, antidepressants, or sedative hypnotics) at some point during pregnancy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major Malformations in Infants	The primary outcome for this study is rates of major malformations among infants exposed in-utero to psychiatric medications. A major malformation is defined as a structural abnormality with surgical, medical, or cosmetic importance. Exclusions include (1) minor anomalies; (2) deformations; (3) physiologic features due to prematurity, such as undescended testes; (4) birthmarks; (5) genetic disorders and chromosomal abnormalities; and (6) any finding by prenatal sonography, such as absence of 1 kidney, or at surgery (or autopsy) that was not identified by an examining pediatrician. This data is collected through review of pediatric medical records through the first twelve months of infants' lives.	Birth up to 1 year; assessed at 8-12 weeks postpartum, assessed through medical records through 1 year of age.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal Gestational Weight Gain	Maternal gestational weight gain is measured by the change in maternal weight from pre-pregnancy to weight at delivery, recorded in pounds.	Change from pre-pregnancy to delivery; assessed at 7 months' gestation and 8-12 weeks postpartum.
Live Birth	Did the pregnancy end in a live birth, assessed as a yes/no outcome.	Birth; assessed at 8-12 weeks postpartum.
Spontaneous Abortion (SAB)	Did a spontaneous abortion (SAB) occur during the pregnancy, assessed as a yes/no outcome.	Any time during pregnancy; assessed at 7 months' gestation and 8-12 weeks postpartum.
Intrauterine Fetal Demise (IUFD)	Did intrauterine fetal demise (IUFD) occur during the pregnancy, assessed as a yes/no outcome.	Any time during pregnancy; assessed at 7 months' gestation and 8-12 weeks postpartum.
Gestational Age	The gestational age of the infant at birth, recorded in weeks and days.	Birth; assessed at 8-12 weeks postpartum.
Preterm Delivery	Was the baby born before 37 weeks gestational age, assessed as a yes/no outcome.	Any time during pregnancy; assessed at 7 months' gestation and 8-12 weeks postpartum.
Birth Weight	Birth weight of the infant, recorded in grams or lbs and oz	Birth; assessed at 8-12 weeks postpartum.
Delivery Method	Was birth vaginal or by C-section; if C-section, emergent: yes/no	Birth; assessed at 8-12 weeks postpartum.
Gestational Diabetes	Gestational diabetes diagnosed during pregnancy, assessed as a yes/no outcome.	Any time during pregnancy; assessed at baseline, 7 months' gestation and 8-12 weeks postpartum.
Gestational Hypertension	Gestational hypertension diagnosed during pregnancy, assessed as a yes/no outcome.	Any time during pregnancy; assessed at baseline, 7 months' gestation and 8-12 weeks postpartum.
Preeclampsia/Eclampsia	Pre-eclampsia or eclampsia diagnosed during pregnancy, assessed as a yes/no outcome.	Any time during pregnancy; assessed at baseline, 7 months' gestation and 8-12 weeks postpartum.
Maternal Postpartum Hemorrhage	Did maternal postpartum hemorrhage occur, assessed as a yes/no outcome.	Birth; assessed at 8-12 weeks postpartum.
Apgar Scores	1-min and 5-min Apgar scores.	Birth; assessed at 8-12 weeks postpartum.
Neonatal Intensive Care Unit (NICU) admission	Was the infant admitted to the NICU, assessed as a yes/no outcome; if yes, number of days in NICU and reason for admission	Birth up to 1 year; assessed at 8-12 weeks postpartum, assessed through medical records through 1 year of age.
Infant Death	Did the infant die before the age of one; assessed as a yes/no outcome.	Birth up to 1 year; assessed at 8-12 weeks postpartum, assessed through medical records through 1 year of age.
Neonatal Extrapyramidal Symptoms	Did movement dysfunction occur in the infant (such as dystonia, akathisia, parkinsonism characteristic symptoms such as rigidity, bradykinesia, tremor, and tardive dyskinesia); assessed as a yes/no outcome.	Birth through 1 year; assessed at 8-12 weeks postpartum, assessed through medical records through 1 year of age.
Poor Neonatal Adaptation Syndrome (PNAS)	Did poor neonatal adaptation syndrome (PNAS) occur (including poor muscle tone, tremors, jitteriness, irritability, seizures, feeding difficulties, sleep disturbances, hypoglycemia, and respiratory distress); assessed as a yes/no outcome	Birth through 1 year; assessed at 8-12 weeks postpartum, assessed through medical records through 1 year of age.
Child Development Outcomes - Ages and Stages Questionnaire (ASQ-3)	Were there developmental concerns, as assessed by the Ages and Stages Questionnaire (ASQ-3).	Assessed at 9 months, year 3, and year 5.
Child Development Outcomes - Preschool Child Behavior Checklist (CBCL)	Were there developmental concerns, as assessed by the Preschool Child Behavior Checklist (CBCL).	Assessed at 9 months, year 3, and year 5.
Breastfeeding	Did breastfeeding occur, assessed as a yes/no outcome; if yes, duration of breastfeeding recorded in weeks.	Assessed at 8-12 weeks postpartum.

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Bristol-Myers Squibb; Alkermes, Inc.; Otsuka America Pharmaceutical; Eisai Inc.; Sage Therapeutics; Supernus Pharmaceuticals, Inc.
• Investigators: Principal Investigator: Lee S Cohen, MD, Massachusetts General Hospital

Publications and helpful links

General 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. Epub 2015 Oct 6.
• 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.
• 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.
• 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.
• 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.
• 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.22m14492.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Helpful Links

• National Pregnancy Registry for Atypical Antipsychotics Website

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2008
• Primary Completion (Estimated): December 1, 2033
• Study Completion (Estimated): December 1, 2033

Study Registration Dates

• First Submitted: November 22, 2010
• First Submitted That Met QC Criteria: November 22, 2010
• First Posted (Estimated): November 23, 2010

Study Record Updates

• Last Update Posted (Estimated): October 24, 2025
• Last Update Submitted That Met QC Criteria: October 22, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Pregnancy; ADHD; Atypical Antipsychotics; Antidepressants; Medication use during pregnancy; Psychiatric medications; Sedative Hypnotics
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Attention Deficit and Disruptive Behavior Disorders; Attention Deficit Disorder with Hyperactivity
• Other Study ID Numbers: 2008P-001861

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO