National Pregnancy Registry for Psychiatric Medications

NCT01246765 | Recruiting

• 1 other identifier: 2008P-001861
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnant Women; Psychotropic Drugs

Keywords

Pregnancy; Medication use during pregnancy; Psychiatric medications; ADHD; Atypical Antipsychotics; Antidepressants; Sedative Hypnotics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (20)

• Maternal Gestational Weight Gain

  Change from pre-pregnancy to delivery; assessed at 7 months' gestation and 8-12 weeks postpartum.

• Live Birth

  Birth; assessed at 8-12 weeks postpartum.

• Spontaneous Abortion (SAB)

  Any time during pregnancy; assessed at 7 months' gestation and 8-12 weeks postpartum.

• Intrauterine Fetal Demise (IUFD)

  Any time during pregnancy; assessed at 7 months' gestation and 8-12 weeks postpartum.

• Gestational Age

  Birth; assessed at 8-12 weeks postpartum.

Study Arms (5)

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.

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Alkermes, Inc.: collaborator
• Eisai Inc.: collaborator
• Otsuka America Pharmaceutical: collaborator
• Supernus Pharmaceuticals, Inc.: collaborator
• Sage Therapeutics: collaborator
• Bristol-Myers Squibb: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Related Publications (12)

• 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.

  PMID: 26441156 BACKGROUND

• 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 DERIVED

• 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 DERIVED

• 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 DERIVED

• 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 DERIVED

• 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.

  PMID: 36602927 DERIVED

• 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 DERIVED

• 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 DERIVED

• 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.

  PMID: 33710399 DERIVED

• 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.

  PMID: 30111186 DERIVED

• 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.

  PMID: 28810177 DERIVED

• 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.

  PMID: 25939066 DERIVED

Related Links

• National Pregnancy Registry for Atypical Antipsychotics Website

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Lee S Cohen, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bryn Rediger

CONTACT

(617) 724-8020; brediger@partners.org

Lee Cohen, MD

CONTACT

(617) 724-8020; lcohen2@partners.org

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 15 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, MGH Center for Women's Mental Health

Study Record Dates

• First Submitted: November 22, 2010
• First Posted: November 23, 2010
• Study Start: November 1, 2008
• Primary Completion (Estimated): December 1, 2033
• Study Completion (Estimated): December 1, 2033
• Last Updated: October 24, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)