Pregnant WomenNCT01246765
National Pregnancy Registry for Psychiatric Medications
An observational study of Pregnant Women and Psychotropic Drugs, run by Massachusetts General Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnant Women, Psychotropic Drugs
- How many people
- 5,000 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Dec 2033
- How long will I take part?
- 15 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant women worldwide will be enrolled in this registry.
Who may be able to join
- Pregnant women
- Age 18-45
- Subjects will be willing to participate over the phone
- Subjects will be able to provide informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Bryn Rediger, BA, (617) 724-8020, admin@womensmentalhealth.org
Lee Cohen, MD
About this study
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.
Read the 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:
- To evaluate neonatal outcomes of infants with prenatal exposure to specific psychiatric medications alone or in combination with other psychotropics.
- To evaluate maternal health outcomes associated with use of psychiatric medications during pregnancy.
- To evaluate neurobehavioral development of children (1 month and older) with prenatal exposure to psychiatric medications.
- Conditions
- Pregnant Women, Psychotropic Drugs
- Keywords
- Pregnancy, Medication use during pregnancy, Psychiatric medications, ADHD, Atypical Antipsychotics, Antidepressants, Sedative Hypnotics
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) * Quviviq (daridorexant) | |
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Maternal gestational weight gain is measured by the change in maternal weight from pre-pregnancy to weight at delivery, recorded in pounds.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Birth; assessed at 8-12 weeks postpartum.
Preterm Delivery
Was the baby born before 37 weeks gestational age, assessed as a yes/no outcome.
Measured: 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
Measured: Birth; assessed at 8-12 weeks postpartum.
Delivery Method
Was birth vaginal or by C-section; if C-section, emergent: yes/no
Measured: Birth; assessed at 8-12 weeks postpartum.
Gestational Diabetes
Gestational diabetes diagnosed during pregnancy, assessed as a yes/no outcome.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Birth; assessed at 8-12 weeks postpartum.
Apgar Scores
1-min and 5-min Apgar scores.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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).
Measured: 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).
Measured: 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.
Measured: Assessed at 8-12 weeks postpartum.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2010 (estimated)
- Study startNov 2008
- Primary completionDec 2033 (estimated)
- Study completionDec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Pregnant WomenStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 15 Months
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Alkermes, Inc., Eisai Inc., Otsuka America Pharmaceutical, Supernus Pharmaceuticals, Inc., Sage Therapeutics, Bristol-Myers Squibb
- Responsible party
- Principal investigator, Lee S. Cohen, MD, Massachusetts General Hospital
- Investigators
- Lee S Cohen, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01246765
- Sponsor's protocol ID
- 2008P-001861
- Status last verified
- Oct 2025
- First submitted
- 22 Nov 2010
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 26441156Swetlik 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.
PubMed 38488388Szpunar 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.
PubMed 37235505Viguera 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.
PubMed 36825887Cohen 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.
PubMed 36716275Viguera 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.
PubMed 36602927Szpunar 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.
PubMed 35909254Viguera 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.
PubMed 34352165Freeman 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.
PubMed 33710399Cohen 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.
PubMed 30111186Panchaud 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.
PubMed 28810177Cohen 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.
PubMed 25939066
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Pregnancy Registry for Psychiatric Medications
- ClinicalTrials.gov ID
- NCT01246765
- Acronym / sponsor ID
- 2008P-001861
- Conditions
- Pregnant Women, Psychotropic Drugs
- Keywords
- Pregnancy, Medication use during pregnancy, Psychiatric medications, ADHD, Atypical Antipsychotics, Antidepressants, Sedative Hypnotics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Alkermes, Inc., Eisai Inc., Otsuka America Pharmaceutical, Supernus Pharmaceuticals, Inc., Sage Therapeutics, Bristol-Myers Squibb
- Study start
- Nov 2008 (actual)
- Primary completion
- Dec 2033 (estimated)
- Study completion
- Dec 2033 (estimated)
- First posted
- 23 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To evaluate neonatal outcomes of infants with prenatal exposure to specific psychiatric medications alone or in combination with other psychotropics.
- To evaluate maternal health outcomes associated with use of psychiatric medications during pregnancy.
- To evaluate neurobehavioral development of children (1 month and older) with prenatal exposure to psychiatric medications.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 15 Months
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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) * Quviviq (daridorexant) |
| 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women worldwide will be enrolled in this registry.
Key inclusion criteria (4 listed)
- Pregnant women
- Age 18-45
- Subjects will be willing to participate over the phone
- Subjects will be able to provide informed consent
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
20 secondary outcomes
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.
Apgar Scores
Time frame: Birth; assessed at 8-12 weeks postpartum.
Neonatal Intensive Care Unit (NICU) admission
Time frame: Birth up to 1 year; assessed at 8-12 weeks postpartum, assessed through medical records through 1 year of age.
Infant Death
Time frame: Birth up to 1 year; assessed at 8-12 weeks postpartum, assessed through medical records through 1 year of age.
Neonatal Extrapyramidal Symptoms
Time frame: Birth through 1 year; assessed at 8-12 weeks postpartum, assessed through medical records through 1 year of age.
Poor Neonatal Adaptation Syndrome (PNAS)
Time frame: 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)
Time frame: Assessed at 9 months, year 3, and year 5.
Child Development Outcomes - Preschool Child Behavior Checklist (CBCL)
Time frame: Assessed at 9 months, year 3, and year 5.
Breastfeeding
Time frame: Assessed at 8-12 weeks postpartum.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Background: PubMed 26441156Cohen 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.
- Derived from this study: PubMed 38488388Swetlik 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.
- Derived from this study: PubMed 37235505Szpunar 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.
- Derived from this study: PubMed 36825887Viguera 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.
- Derived from this study: PubMed 36716275Cohen 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.
- Derived from this study: PubMed 36602927Viguera 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.
- Derived from this study: PubMed 35909254Szpunar 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.
- Derived from this study: PubMed 34352165Viguera 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.
- Derived from this study: PubMed 33710399Freeman 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.
- Derived from this study: PubMed 30111186Cohen 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.
- Derived from this study: PubMed 28810177Panchaud 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.
- Derived from this study: PubMed 25939066Cohen 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.
- National Pregnancy Registry for Atypical Antipsychotics WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lee S Cohen, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnant Women and Psychotropic Drugs, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bryn Rediger ((617) 724-8020, brediger@partners.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01246765, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.