National Pregnancy Registry for Psychiatric Medications

October 22, 2025 updated by: Lee S. Cohen, MD, Massachusetts General Hospital
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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Contact:
        • Principal Investigator:
          • Lee Cohen, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Birth up to 1 year; assessed at 8-12 weeks postpartum, assessed through medical records through 1 year of age.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Maternal Gestational Weight Gain
Time Frame: Change from pre-pregnancy to delivery; assessed at 7 months' gestation and 8-12 weeks postpartum.
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
Time Frame: Birth; assessed at 8-12 weeks postpartum.
Did the pregnancy end in a live birth, assessed as a yes/no outcome.
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.
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)
Time Frame: Any time during pregnancy; assessed at 7 months' gestation and 8-12 weeks postpartum.
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
Time Frame: Birth; assessed at 8-12 weeks postpartum.
The gestational age of the infant at birth, recorded in weeks and days.
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.
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
Time Frame: Birth; assessed at 8-12 weeks postpartum.
Birth weight of the infant, recorded in grams or lbs and oz
Birth; assessed at 8-12 weeks postpartum.
Delivery Method
Time Frame: Birth; assessed at 8-12 weeks postpartum.
Was birth vaginal or by C-section; if C-section, emergent: yes/no
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 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
Time Frame: Any time during pregnancy; assessed at baseline, 7 months' gestation and 8-12 weeks postpartum.
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
Time Frame: Any time during pregnancy; assessed at baseline, 7 months' gestation and 8-12 weeks postpartum.
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
Time Frame: Birth; assessed at 8-12 weeks postpartum.
Did maternal postpartum hemorrhage occur, assessed as a yes/no outcome.
Birth; assessed at 8-12 weeks postpartum.
Apgar Scores
Time Frame: Birth; assessed at 8-12 weeks postpartum.
1-min and 5-min Apgar scores.
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.
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
Time Frame: Birth up to 1 year; assessed at 8-12 weeks postpartum, assessed through medical records through 1 year of age.
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
Time Frame: Birth through 1 year; assessed at 8-12 weeks postpartum, assessed through medical records through 1 year of age.
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)
Time Frame: Birth through 1 year; assessed at 8-12 weeks postpartum, assessed through medical records through 1 year of age.
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)
Time Frame: Assessed at 9 months, year 3, and year 5.
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)
Time Frame: Assessed at 9 months, year 3, and year 5.
Were there developmental concerns, as assessed by the Preschool Child Behavior Checklist (CBCL).
Assessed at 9 months, year 3, and year 5.
Breastfeeding
Time Frame: Assessed at 8-12 weeks postpartum.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Massachusetts General Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Bristol-Myers Squibb
Alkermes, Inc.
Otsuka America Pharmaceutical
Eisai Inc.
Sage Therapeutics
Supernus Pharmaceuticals, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lee S Cohen, MD, Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2008

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2033

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2033

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 22, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 22, 2010

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 23, 2010

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 24, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 22, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2008P-001861

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pregnant Women

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings